10037310 Rev U

Change Summary:
Revision Date Author Description
[redacted]

Summary:

This Risk process Management covers the PB560 Ventilator. It was completed with input from the following team: .

Access Residual Risk - RPN # after Risk Mitigations have been implemented (Refer to Process Failure
Analysis Procedure DC00070840:

Page 1 of 21
 Process Flow Map - PB560
Process Flow Map for PB560

Process: PB560 Assembly Prepared by [redacted] Activity Classes Operation Delay

Responsibility [redacted] Date: Refer to Agile Inspection Transport

Revision U Inspection/Operation Storage
Decision

ORIGIN INPUTS PROCESS STEPS OUTPUT Destination

KPIV's Msm Sys Type Activity Class Process Step KPOV's MSN sys Specs

as per Galway
New Material for Galway Requirements
Start Receiving, Part Numbers, Revisions Procedure Operation, Storage Requirements Planning Warehouse Storage
Receiving disposition Planning System (BPCS)
System (BPCS)

Incoming Inspection, Released Mfg

Receiving Visual, verniers, Optical. Equipment Inspection Acceptable material Released Mfg drawings, as per drawing Line storage
drawings, IPC-A-610, II019105
Incoming Inspection

Incoming Inspection,
Unpack material & store in tote bins etc N/A Procedure Storage Segregated material BOMs for product Tube Cutting
Stores
Storage location Fixtures Calibrated Ruler Equipment Operation Lower Enclusore Assembly
Assembly Procedure 10021625, PHR
Storage location G-QAP004 Procedure Operation Tube Cutting Lower Enclusore Assembly
10021626
10095161, 10095162 &
Storage location Materials 10021625 Material Operation Material cut to length Calibrated ruler Lower Enclusore Assembly
10095163
Storage location Trained operator Procedure Operation Lower Enclusore Assembly

Storage location Unpack material & store in tote bins etc N/A Procedure Storage Segregated material BOMs for product
10095161, 10095162 &
Storage location Fixtures 3834400, 3835100, 3834500, 3835000 Equipment Operation Assembled unit Final Assembly Enclosure
10095163
Assembly Procedure 10095161, Bottom Enclosure sub-
Storage location G-QAP004 Procedure Operation Top Enclosure Assembly
10095162 & 10095163 PHR 10038461 assembly
10095161, 10095162 & 10095163,
Storage location Materials Materials Operation Top Enclosure Assembly
4096600
G-QCAL041 and G-
Storage location Air De-ioniser and air gun Charge Plate Analyser Equipment Operation Top Enclosure Assembly
QCAL234
Sub Assembly, Main
Torque set to 4.4in-lb, 8.9in-lb +/- 0.5, 4.4in-lb +/-
Storage location Torque tooling Static Torque setter, URYU Tooling Operation Assembly. G-QCAL030 Top Enclosure Assembly
8.9in-lb 0.5,
Trained operator Procedure Operation Top Enclosure Assembly
Assembly Procedures 10095161,
Storage location Procedure Operation Assembled unit Safety Analyzer Test
10095162, 10095163
Storage location, Bottom 10095161, 10095162 & 10095163
Enclosure Assy
Materials Materials Operation Assembled unit Safety Analyzer Test
4096600
Torque set to 4.4in-lb, 8.9in-lb +/- 0.5, 4.4in-lb +/-
Storage location Torque tooling Static Torque setter, URYU Tooling Operation G-QCAL030 Safety Analyzer Test
8.9in-lb 0.5,
Trained operator G-QAP017 Procedure Operation Safety Analyzer Test
G-QCAL041 and G-
Storage location Air De-ioniser and air gun Charge Plate Analyser Tooling Operation Safety Analyzer Test
QCAL234

Storage location Metron QA-90 Safety Test Analyser Equipment Operation Calibrated Tester 10036007
Safety Test - Safety Analyzer
10037310U00 2/21
 Process Flow Map - PB560
Safety Test - Safety Analyzer
Storage location Cables Equipment Operation 10036007 Download Process
Storage location UUT Equipment Operation Unit with application s/w 10036007 Download Process
Storage location Safety Test Process Equipment Operation 10036007 Download Process
Trained Operator 10036007 Procedure Unit with application s/w 10036007 Download Process

Storage location Cables Equipment Operation System Test

Storage location PC Equipment Operation Unit with application s/w 10036007 System Test
Storage location UUT Equipment Operation Software Download Process Unit with application s/w 10036007 System Test
Storage location S/W Equipment Operation System Test
Storage location Download process Equipment Operation 10036007 System Test
Trained Operator 10036007 Procedure Unit with application s/w 10036007 System Test

Unit with s/w downloaded

Storage location System Test procedure 10036007 Procedure Inspection /Test 10036007 Test & Battery Charge
and calibration tested
Unit with s/w downloaded
Storage location Trained Operator 10036007 Procedure Inspection /Test 10036007 Test & Battery Charge
and calibration tested
System Calibration & Test
Unit with s/w downloaded
Storage location PC & S/W Equipment Inspection /Test 10036007 Test & Battery Charge
and calibration tested
Unit with s/w downloaded
Storage location UUT Equipment Inspection /Test 10036007 Test & Battery Charge
and calibration tested
Storage location Cables Equipment Inspection /Test

Unit ready for Final

Storage location Assembly Procedure 10036007 Proceduure Operation / Test 10036007 System Final Test
System Test
Unit ready for Final
Storage location Materials 4096600 Materials Operation / Test Battery Discharge / Charge 10036007 System Final Test
System Test
Unit ready for Final
Trained operator 10036007 Procedure Operation 10036007 System Final Test
System Test
Unit ready for Final
Storage location Test Equipment Equipment Operation 10036007 System Final Test
System Test

Storage location System Test procedure 10039030 Procedure Inspection /Test Final Tested Unit 10039030 Pack Unit
Storage location Trained Operator 10039030 Procedure Inspection /Test Final Tested Unit 10039030 Pack Unit
Storage location PC & S/W 10039030 Procedure Inspection /Test Final Tested Unit 10039030 Pack Unit
System Final Test
Storage location UUT Equipment Inspection /Test Final Tested Unit 10039030 Pack Unit
Storage location Cables Equipment Inspection /Test Final Tested Unit 10039030 PB560 10039196 Pack Unit

Product Release
Storage location Assembly Instruction 10039897 Procedure Operation /Inspection Packed Unit 10039897
Authorisation
Product Release
Storage location Materials Materials Operation 10039897
Authorisation
UDI Barcode Grading Verifier / Device & Carton Labels G-QAP019 (Calibration Tasks performed as per PB560 Packing &
On line Equipment QS00002016 procedure Operation / Inspection
equipment Pack unit Verified as UDI Compliant procedure) applicable procedures Labelling Procedure
(All product)
PM: Testers and Test Stands, G-AMFG-
Workstation Verification Scanner 1180-00,10149038 verification scanner Procedure Packed Unit 10149038 Product Release
operation procedure
Operation/Inspection
Product Release
Trained Operator 10039897 Procedure Operation 10039897
Authorisation
Product Release
Storage location UUT Equipment Operation
Authorisation

Product Audit Release Product Released for Signature on DHR

Storage location Assembly instruction 10021754 Procedure Operation Shipping
Authorisation Shipment 10038461
(All product) Product Released for Signature on DHR
Storage location Trained Operator 10021754 Procedure Operation Shipping
Shipment 10048361

Customer
Ship unit

Product manufactured in Humidity monitored per

Humidity Humidity Sensor Procedure Inspection 22%-78% RH
acceptable humidity range G-AMFG-1110-00
Environmental Product manufactured in
Temperature monitored
Temperature Hanwell Temperature Procedure Inspection acceptable temperature 16.5 to 29.5deg C
per G-AMFG-1110-00
range

10037310U00 3/21
 Process FMEA for PB560

Process/Product
Process/Product
Failure
Failure Modes
Modes and
and Effects
Effects Analysis
Analysis
(FMEA)
(FMEA)

Process or Product Name: PB560 Assembly, Test & Pack Updated by: [redacted] Page __1__ of __16__
Responsible: [redacted] FMEA Date (Refer to AGILE) U

S
e
v R
O D S O D R
e P
CTQ CTS Process Function Process Step Key Process Input Potential Failure Mode Potential Failure Effects Hazard Tag r Potential Causes C Current Controls E Actions Recommended Resp. Actions Taken E C E P
N
i C T V C T N
t
y

How often does cause or

FM occur?
Critical to Critical to Safety: Operation Name for Description of step What is the Key Process In what ways does the Key What is the impact on the Key Unique Identifier for the How What causes the Key What are the existing controls and What are the actions for reducing the Whose What are the completed

How well can you detect

cause or FM?
Quality Risk documents listed Manufacturing task within operation Input? Input go wrong? Output Variables (Customer hazard severity Input to go wrong? procedures (inspection and test) that occurrence of the Cause, or improving Responsible for actions taken with the
in this column must Requirements) or internal effects prevent either the cause or the Failure detection? Should have actions only on the recalculated RPN? Be
be reviewed prior to requirements? the Mode? Should include an SOP high RPN's or easy fixes. recommended sure to include
making any changes process number. action? completion month/year
to procedures in Key
Process Input or
Current Controls

Tube Cutting Tube Cutting Tube cutting fixture set Incorrect setting Tubes cut to the incorrect N/A Procedure not followed, Measure at start and end per procedure N/A N/A N/A
/Assembly (PB560 /Assembly (PB560 up. length, can not assemble operator error 10095162; Ruler is calibrated and metric
Assy Procedure Assy Procedure 4 10 only. 1 40 - - - -
10095162 / 10095162 /
10021625) 10021625)
Tube cutting fixture set Incorrect setting Tubes cut to the incorrect N/A Procedure not followed, Measure at start and end per procedure N/A N/A N/A
up. length causing kinks. operator error 10095162;; Ruler is calibrated and metric
4 10 only. Tubes selected prior to assembly 1 40 - - - -
onto valve. Product 100% tested.

Tube cutting Incorrect setting Tube cut shorter than N/A Procedure not followed, Measure at start and end per N/A N/A N/A
specification but can be operator error procedure10095162;; Ruler is calibrated
assembled 7 10 and metric only. Tubes selected prior to 1 70 - - - -
assembly onto valve. Product 100%
tested.
Tube cutting Flash after cut Potentially impact on sensor N/A poor quality cut Precision fixture. Inspection of first and N/A N/A N/A
7 1 last part during cutting for flash. 540 PM 3 21 - - - -
procedure verifys clean cut.
Tubing specification Incorrect Tubing type or Tubes do not assemble to N/A Miss-labelling of tubing Supplier Qualification: Receiving against N/A N/A N/A
size fittings or is incorrect type 7 10 manufacturer's p/n. Incoming Inspection 1 70 - - - -
Process.
Tubing specification Incorrect Tubing type or Tubing kinks. N/A Miss-labelling of tubing Supplier Qualification: Receiving against N/A N/A N/A
size 7 10 manufacturer's p/n. Incoming Inspection 1 70 - - - -
Process.
Process task Dirt entering tubing Impact performance of N/A Dirt in production area Production area cleaned daily N/A N/A N/A
7 1 1 7 - - - -
assembly
Process task Silicone Bumpers Missing Potential reliability issue in the N/A Process operative error Visual, Cosmetic Check, Final QA. N/A N/A N/A
4 2 3 24 - - - -
field
Inspiratory Conical Inspiratory Conical Trained Operator Label placed with air bubble Cosmetic Impact N/A Process operative error Visual, Cosmetic Check, Final QA. N/A N/A N/A
Block (PB560 Assy Block (PB560 Assy
Procedure 10095162) Procedure 10095162) 2 10 3 60 - - - -

Process task Label incorrectly placed Customer is miss directed N/A Process operative error Training; all procedures will be peer N/A N/A N/A
reviewed prior to approval; label shape is
8 10 unique to application. Procedure contains 1 80 - - - -
photo checks
Process task Inspiratory block is not Label falls off N/A Process operative error Process instruction; training. Final N/A N/A N/A
8 10 1 80 - - - -
cleaned inspection contains a label check.
Inspiratory block Flash on tube fittings Leaks - obstructions N/A Vendor quality issue Qualified Vendor / Galway Incoming N/A N/A N/A
7 10 Inspection Procedure.100% inspection in 1 70 - - - -
place at incoming
Process task Tubes are incorrectly Tubing does not assemble N/A Process operative error If tubings misoriented, assy will not N/A N/A N/A
placed 4 10 assemble into unit (diff. lengths of tubing) 2 80 - - - -

Process task Tubes are incorrectly Kinks in the tubing. N/A Process operative error 10095162;, training. Photos in procedure N/A N/A N/A
5 10 1 50 - - - -
placed for direction.
Process task FiO2 connector is Connector cannot be N/A Process operative error Parts are keyed, 10095162;, training N/A N/A N/A
incorrectly aligned with tightened correctly. 2 10 3 60 - - - -
inspiratory block
Process task FiO2 connector is not Connector is loose N/A Fixture 10038462 Training. Additional warnings in N/A N/A N/A
tightened fully as connector contacts inspirotory procedure. Fitting will be loose during
is close to side of block wall while test.
inspiratory block. Fixture 4 tightening 10 2 80 - - - -
torques against inspiratory
block.
Process task Dirt entering conical block Impact performance of N/A Dirt in production area Production area cleaned daily N/A N/A N/A
7 1 1 7 - - - -
assembly
Process task Cable harness not routed Cable makes loose electrical N/A Process operative error Process instruction training. N/A N/A N/A
correctly / too much connection over time leading 7 2 3 42 - - - -
pressure. to failure
Expiratory Conical Expiratory Conical Trained Operator Label placed with air bubble Cosmetic Impact N/A Process operative error Visual, Cosmetic Check, Final QA. N/A N/A N/A
Block (PB560 Assy Block (PB560 Assy
Procedure 10095162) Procedure 2 10 3 60 - - - -
10095162;)
Process task Label incorrectly placed Customer is miss directed N/A Process operative error Training; all procedures will be peer N/A N/A N/A
reviewed prior to approval; label shape is
8 10 unique to application. Procedure contains 1 80 - - - -
photo checks
Process task Expiratory block is not Label falls off N/A Process operative error Process instruction; training. Final N/A N/A N/A
8 10 1 80 - - - -
cleaned inspection contains a label check.
Process task Tubes are incorrectly Tubing does not assemble N/A Process operative error If tubings misoriented, assy will not N/A N/A N/A
placed 4 10 assemble into unit (diff. lengths of tubing) 2 80 - - - -

Process task Tubes are incorrectly Kinks in the tubing. N/A Process operative error 10095162;, training. Photos in procedure N/A N/A N/A
5 10 1 50 - - - -
placed for direction.

Page 4 of 21 10037310U00
 Process FMEA for PB560

S
e
v R
O D S O D R
e P
CTQ CTS Process Function Process Step Key Process Input Potential Failure Mode Potential Failure Effects Hazard Tag r Potential Causes C Current Controls E Actions Recommended Resp. Actions Taken E C E P
N
i C T V C T N
t
y

How often does cause or

FM occur?

cause or FM?
Critical to Critical to Safety: Operation Name for Description of step What is the Key Process In what ways does the Key What is the impact on the Key Unique Identifier for the How What causes the Key What are the existing controls and What are the actions for reducing the Whose What are the completed

How well can you detect

Quality Risk documents listed Manufacturing task within operation Input? Input go wrong? Output Variables (Customer hazard severity Input to go wrong? procedures (inspection and test) that occurrence of the Cause, or improving Responsible for actions taken with the
in this column must Requirements) or internal effects prevent either the cause or the Failure detection? Should have actions only on the recalculated RPN? Be
be reviewed prior to requirements? the Mode? Should include an SOP high RPN's or easy fixes. recommended sure to include
making any changes process number. action? completion month/year
to procedures in Key
Process Input or
Current Controls

Process task Tubes are loosely Tube becomes disconnected N/A Process operative error process instruction 10095162;training; N/A N/A N/A
connected over time 8 10 test instructions 10036007; 10039030. 1 80 - - - -
Check before closing unit.
Torque Driver Driver set below Fittings become loose N/A Torque driver is Calibration Procedure; if tool dropped, N/A N/A N/A
specification 8 incorrect set. 1 CAL Lab are notified etc as per 5 40 - - - -
10095162;
Torque Driver Driver set above Fittings are damaged N/A Torque driver is Calibration Procedure; if tool dropped, N/A N/A N/A
specification 8 incorrect set. 1 CAL Lab are notified etc as per 2 16 - - - -
10095162;
Process task Dirt entering exhalation Impact performance of N/A Dirt in production area Production area cleaned daily N/A N/A N/A
7 1 1 7 - - - -
block assembly
Battery Cover (PB560 Battery Cover (PB560 Process task Label placed with air bubble Cosmetic Impact N/A Process operative error Training,10095163; Cosmetic check in N/A N/A N/A
Assy Procedure Assy Procedure procedure
10095163) 10095163) 2 10 3 60 - - - -

Process task Battery Cover is not Battery label falls off N/A Process operative error Process instruction; training. Final N/A N/A N/A
4 10 1 40 - - - -
cleaned inside inspection contains a label check.
Process task Battery Cover is not Adhesive stops fall off, battery N/A Process operative error Training, 10095163; Only potential N/A N/A N/A
cleaned inside is not secured. opportunity for stops to fall off is during
7 10 assembly; Stops checked immeadiately 1 70 - - - -
prior to assembly
Process task Adhesive stops not fitted Battery in not secured, system N/A Process operative error Training, 10095163 Only potential N/A N/A N/A
connection to battery could be opportunity for stops to fall off is during
damaged 7 10 assembly; Stops checked immeadiately 1 70 - - - -
prior to assembly
Process task Battery Cover is not Label falls off, no direction for N/A Process operative error Shipping audit. Customer has the N/A N/A N/A
cleaned outside user. 8 10 operation manual for reference. There is 1 80 - - - -
a label check at pack.
Blower Housing Blower Housing Process task Foam strips too long Interference to overall N/A Process operative error Specific length per procedure. Cut with N/A N/A N/A
(PB560 Assy (PB560 Assy assembly calibrated fixture. Length is verified by
Procedure 10095162) Procedure 10095162) 5 10 how it fits in assembly. 1 50 - - - -

Process task Foam strips too short Blower assembly could vibrate N/A Process operative error Specific length per procedure. Cut with N/A N/A N/A
3 10 calibrated fixture. Length is verified by 1 30 - - - -
how it fits in assembly.
Process task Turbine not cleaned Foam on top of blower might N/A Process operative error Training, 10095162 (top of blower is N/A N/A N/A
not stick. cleaned); Foam will be held in place by
4 10 top housing. Occurrence of falling off are 1 40 - - - -
remote.
Process task Turbine not cleaned Collar does not stick and N/A Process operative error Training, 10095162 (top of blower is N/A N/A N/A
Power Supply / Blower cleaned). Check in procedure.
Harness ferrite is unsupported 4 10 1 40 - - - -

Torque Driver Spacers too tight Turbine housing damage N/A Torque driver is Calibration Procedure; if tool dropped, N/A N/A N/A
8 incorrect set. 1 CAL Lab are notified etc as per 3 24 - - - -
10095162
Torque Driver Spacers too loose Spacers work loose N/A Torque driver is Calibration Procedure; if tool dropped, N/A N/A N/A
8 incorrect set. 1 CAL Lab are notified etc as per 5 40 - - - -
10095162
Process task Loctite not applied Screws work loose N/A Process operative error Training, 10095162. Procedure contains N/A N/A N/A
8 10 1 80 - - - -
check for loctite
Process task Blower card mis-orientated Can not assemble shield N/A Process operative error Training, 10095162 N/A N/A N/A
4 10 2 80 - - - -
Process task Cable is not wrapped Cable is pinched between N/A Process operative error Training, 10095162(check in place) N/A N/A N/A
7 10 1 70 - - - -
correctly shield and turbine.
Process task Mis-handling of blower card Unit fails over time; impacts N/A Process operative error Training N/A N/A N/A
8 10 1 80 - - - -
- ESD damage production yield
Process task Mis-handling of blower card Physical damage N/A Process operative error Training N/A N/A N/A
8 10 1 80 - - - -
Process task Connect the power Blower does not function N/A Process operative error 10095162 procedure, training, N/A N/A N/A
supply/blower harnesses 8 10 10036007 / 10039030 test procedures, 1 80 - - - -
(3822500) incorrectly Keying of connection
Process task power supply/blower Blower does not function N/A Process operative error 10095162 procedure, training, N/A N/A N/A
Harnesses not connected 8 10 10036007 / 10039030 test procedures, 1 80 - - - -
Keying of connection
Process task Tubing not connected Blower does not function N/A Process operative error 10095162 procedure, training, N/A N/A N/A
8 10 10036007 / 10039030 test procedures, 1 80 - - - -
Keying of connection
Tubing specification Incorrect Tubing type or Tubes do not assemble to N/A Miss-labelling of tubing Control of suppliers (AML) ref G-QAP007; N/A N/A N/A
size fittings. GMP audit to be completed as part of
4 3 validation (material is segregated) 1 12 - - - -

Tubing specification Incorrect Tubing type or Tubing kinks. N/A Miss-labelling of tubing Control of suppliers (AML) ref G-QAP007; N/A N/A N/A
size GMP audit to be completed as part of
7 3 validation (material is segregated) 3 63 - - - -

Process task Tubing connected to Will fail test N/A Process operative error 10036007 / 10039030 test procedures N/A N/A N/A
8 10 1 80 - - - -
incorrect fitting
Hand Torque Driver Torque too high Damage threading on blower N/A Torque driver is Calibration Procedure; if tool dropped, N/A N/A N/A
housing incorrect set. CAL Lab are notified etc as per
10095162; If torque is too high, threading
7 1 may be shredded and torque tool will not 3 21 - - - -
'click' (indication of torque level
achieved).

Page 5 of 21 10037310U00
 Process FMEA for PB560

S
e
v R
O D S O D R
e P
CTQ CTS Process Function Process Step Key Process Input Potential Failure Mode Potential Failure Effects Hazard Tag r Potential Causes C Current Controls E Actions Recommended Resp. Actions Taken E C E P
N
i C T V C T N
t
y

How often does cause or

FM occur?

cause or FM?
Critical to Critical to Safety: Operation Name for Description of step What is the Key Process In what ways does the Key What is the impact on the Key Unique Identifier for the How What causes the Key What are the existing controls and What are the actions for reducing the Whose What are the completed

How well can you detect

Quality Risk documents listed Manufacturing task within operation Input? Input go wrong? Output Variables (Customer hazard severity Input to go wrong? procedures (inspection and test) that occurrence of the Cause, or improving Responsible for actions taken with the
in this column must Requirements) or internal effects prevent either the cause or the Failure detection? Should have actions only on the recalculated RPN? Be
be reviewed prior to requirements? the Mode? Should include an SOP high RPN's or easy fixes. recommended sure to include
making any changes process number. action? completion month/year
to procedures in Key
Process Input or
Current Controls

Hand torque Driver Torque too low Collar could shake loose N/A Torque driver is Calibration Procedure; if tool dropped, N/A N/A N/A
7 incorrect set. 1 CAL Lab are notified etc as per 6 42 - - - -
10095162
Process task Collar not fitted Power Supply Blower Harness N/A Process operative error Note in procedure to check for collars N/A N/A N/A
ferrite is unsupported 4 10 1 40 - - - -

Process task CPU / Power supply Blower does not function N/A Process operative error 10095162 procedure, training, N/A N/A N/A
harness (3822300) not 8 10 10036007 / 10039030 test procedures. 1 80 - - - -
connected
Process task CPU / Power supply Blower does not function N/A Process operative error 10095162 procedure, training, N/A N/A N/A
harness (3822300) not 8 10 10036007 / 10039030 test procedures, 1 80 - - - -
assembled correctly Keying of connection
Process task CPU / blower driver harness Blower does not function N/A Process operative error 10095162 procedure, training, N/A N/A N/A
(3822400) not connected 8 10 10036007 / 10039030 test procedures. 1 80 - - - -

Process task CPU / blower driver harness Blower does not function N/A Process operative error 10095162 procedure, training, N/A N/A N/A
(3822400) not assembled 8 10 10036007 / 10039030 test procedures, 1 80 - - - -
correctly Keying of connection
Process task Dirt entering blower Impact performance of N/A Dirt in production area Production area cleaned daily N/A N/A N/A
7 1 1 7 - - - -
assembly
Upper Housing Upper Housing Process task Handle mis-orientated Parts will not assemble N/A Process operative error Only one orientation, 10095163 N/A N/A N/A
(PB560 Assy (PB560 Assy procedure, training
Procedure 10095163) Procedure 10095163) 4 10 1 40 - - - -

Torque Driver Screws too tight Handle is damaged N/A Torque driver is Calibration Procedure; if tool dropped, N/A N/A N/A
4 incorrect set. 1 CAL Lab are notified etc as per 6 24 - - - -
10095163
Torque Driver Screws too loose Handle becomes loose N/A Torque driver is Calibration Procedure; if tool dropped, N/A N/A N/A
4 incorrect set. 1 CAL Lab are notified etc as per 6 24 - - - -
10095163
Process task Housing is not cleaned Membrane does not stick N/A Supplier neglects to Supplier cleans Housing prior to painting N/A N/A N/A
down properly clean housing / process: Operator cleaning task is
7 Process operator 3 secondary. Training, procedure 3 63 - - - -
neglects to clean 10095163
housing
Process task Housing is not cleaned Alarm Label does not stick N/A Supplier neglects to Supplier cleans Housing prior to painting N/A N/A N/A
down properly clean housing / process: Operator cleaning task is
4 Process operator 3 secondary. Training, procedure 3 36 - - - -
neglects to clean 10095163
housing
Process task Membrane not located Damage due to relocation N/A Process operative error Design of membrane and corresponding N/A N/A N/A
correctly 7 10 recess in top housing: only one possible 1 70 - - - -
install.
Process task Membrane not located Cosmetic Impact N/A Process operative error Training. References in procedure N/A N/A N/A
4 10 1 40 - - - -
correctly
Process task Flex tail not located through Part will not assemble N/A Process operative error 10095163; training N/A N/A N/A
4 10 2 80 - - - -
slot
Process task Even pressure is not Membrane will become N/A Process operative error Training. References in procedure N/A N/A N/A
7 10 1 70 - - - -
applied detached
Process task Switch panel damaged Push button or Alarm LED not N/A Damage due to mis Physical condition checked as part of IIP, ALARP - Review PFMEA as part of G- PB560 Reviewed historical failure
during manufacture or working handling during system test excercises all keypad QAP056. Review failure rate for keypads to Manufacturing yield data for PB540.
assembly. manufacture, shipping, buttons and LEDs. Keypads lot revise occurance. Engineer. Based on this data,
8 assembly. 5 controlled. Warnings in mainline 3 120 reduce occurrence 8 3 3 72
procedure regarding handling of keypads.

Switch Cover (PB560 Switch Cover (PB560 Process task Spring mis-assembled Spring does not work N/A Process operative error Check in procedure 10095161 to ensure N/A N/A N/A
Assy Procedure Assy Procedure correct operation
10095161) 10095161) 7 10 1 70 - - - -

Process task Axle not cantered Parts will not assemble N/A Process operative error Check in procedure 10051246 to ensure N/A N/A N/A
4 10 1 40 - - - -
correct operation
Process task Place spring through the Parts will not assemble N/A Process operative error Check in procedure 10051246 to ensure N/A N/A N/A
4 10 1 40 - - - -
wrong opening correct operation
Process task Retaining ring not secured Parts will become dislodged in N/A Part not assembled Check in procedure 10095161 N/A N/A N/A
correctly to lower housing the field 8 correctly as per 10 1 80 - - - -
procedure
Lower Housing Lower Housing Process task ESD label not fitted Service warning not present N/A Process operative error All Product should be serviced in field N/A N/A N/A
(PB560 Assy (PB560 Assy only be trained service personnel using
Procedure 10095161) Procedure 10095161) 2 10 Service manual. 3 60 - - - -

Process task Air inlet label not fitted End user will may need to N/A Process operative error Revision of label needs to be recorded on N/A N/A N/A
refer to manual DHR as per 10095161. Product Release
4 10 procedure verifies DHR completion. 1 40 - - - -

Process task O2/RA/SP label not fitted End user will may need to N/A Process operative error Revision of label needs to be recorded on N/A N/A N/A
refer to manual DHR as per 10095161. Product Release
4 10 procedure verifies DHR completion. 1 40 - - - -

Process task Identification label is not Traceability is lost on the N/A Process operative error Revision of label needs to be recorded on N/A N/A N/A
fitted device. 8 10 DHR as per 10095161 S/N is read during 1 80 - - - -
several steps of process
Process task Warning label is not fitted Operator will be mis-directed N/A Process operative error Revision of label needs to be recorded on N/A N/A N/A
DHR as per 10095161. Product Release
6 10 procedure verifies DHR completion. 1 60 - - - -

Page 6 of 21 10037310U00
 Process FMEA for PB560

S
e
v R
O D S O D R
e P
CTQ CTS Process Function Process Step Key Process Input Potential Failure Mode Potential Failure Effects Hazard Tag r Potential Causes C Current Controls E Actions Recommended Resp. Actions Taken E C E P
N
i C T V C T N
t
y

How often does cause or

FM occur?

cause or FM?
Critical to Critical to Safety: Operation Name for Description of step What is the Key Process In what ways does the Key What is the impact on the Key Unique Identifier for the How What causes the Key What are the existing controls and What are the actions for reducing the Whose What are the completed

How well can you detect

Quality Risk documents listed Manufacturing task within operation Input? Input go wrong? Output Variables (Customer hazard severity Input to go wrong? procedures (inspection and test) that occurrence of the Cause, or improving Responsible for actions taken with the
in this column must Requirements) or internal effects prevent either the cause or the Failure detection? Should have actions only on the recalculated RPN? Be
be reviewed prior to requirements? the Mode? Should include an SOP high RPN's or easy fixes. recommended sure to include
making any changes process number. action? completion month/year
to procedures in Key
Process Input or
Current Controls

Process task Adhesive feet not fitted. Unit can slide on resting N/A Process operative error Procedure 10095161 training N/A N/A N/A
surface / potential excess 1 10 1 10 - - - -
vibration on some surfaces
Polymide Tube Prep Tool Tube 'Flaring' Tool not Ends of o2 Connector Tubing N/A Process operative error Detail added to Procedure 10095161 to N/A N/A N/A
employed are not widened, making use fixture prior to insertion, also
insertion more difficult. 2 10 statement "ensure tubing is pushed all 3 60 - - - -
the way in". Operators are Trained in
procedure and in use of fixture.
Torque Driver Over tighten O2 connection Damage to connection N/A Torque driver is Calibration Procedure; if tool dropped, N/A N/A N/A
incorrect set. CAL Lab are notified etc as per
10095161; If torque is too high, plastic
7 1 threading will be shredded and torque 3 21 - - - -
tool will not 'click' (indication of torque
level achieved).
Torque Driver Under tighten O2 O2 connection will come loose N/A Torque driver is Calibration Procedure; if tool dropped, N/A N/A N/A
connection incorrect set. CAL Lab are notified etc as per
7 1 10095161, 10095162, 10095163; 4 28 - - - -
connection is used during test process;
unit is serviced periodically in the field;
Process task Over tighten O2 connection Connector damage N/A Process operative error Procedure 10095161, 10095162, N/A N/A N/A
3 10 1 30 - - - -
fastener 10095163; training
Process task Under tighten O2 Leaks N/A Process operative error Procedure 10095161, 10095162, N/A N/A N/A
7 10 1 70 - - - -
connection fastener 10095163; training
Torque Driver Over tighten alarm call Damage to connection N/A Torque driver is Calibration Procedure; if tool dropped, N/A N/A N/A
connection incorrect set. CAL Lab are notified etc as per
10095161; If torque is too high, plastic
3 1 threading will be shredded and torque 6 18 - - - -
tool will not 'click' (indication of torque
level achieved).
Torque Driver Under tighten alarm call Alarm call connection will N/A Torque driver is Calibration Procedure; if tool dropped, N/A N/A N/A
connection come loose incorrect set. CAL Lab are notified etc as per
7 1 10095161; connection is used during test 6 42 - - - -
process; unit is serviced periodically in
the field;
Process task Knurled knob not fitted Expiratory block can be N/A Process operative error Procedure 10095161; training. Check at N/A N/A N/A
installed but cannot be 5 10 final QA 1 50 - - - -
secured
Process task Foam is cut too short Turbine will not sit level if the N/A Process operative error Training, 10095161 N/A N/A N/A
foam moves during assembly. 3 10 1 30 - - - -

Process task Foam is cut too long Turbine will not fit correctly N/A Process operative error Training, 10095161 N/A N/A N/A
3 10 1 30 - - - -
and will not assemble
Process task Foam not placed Turbine will not be secured in N/A Process operative error Training; check in place in 10095161 to N/A N/A N/A
place ensure that foam is in place. Foam is still
3 10 visible after blower is integrated into 1 30 - - - -
assembly
Torque Driver Torque too high Damage to O2 valve (due to 4 N/A Torque driver is Calibration Procedure; if tool dropped, N/A N/A N/A
screws being overtightened) incorrect set. CAL Lab are notified etc as per
10095161; If torque is too high, plastic
7 1 threading will be shredded and torque 3 21 - - - -
tool will not 'click' (indication of torque
level achieved).
Torque Driver Torque too low O2 valve could shake loose N/A Torque driver is Calibration Procedure; if tool dropped, N/A N/A N/A
(due to 4 screws being 7 incorrect set. 1 CAL Lab are notified etc as per 6 42 - - - -
undertightened) 10095161
Process task Bracket fitted wrong way Cause assembly issues later N/A Process operative error Procedure w/ 3 pictorials N/A N/A N/A
4 10 2 80 - - - -
around
Tubing Specification Incorrect type of tubing Assembly issues N/A Miss-labelling of tubing Receiving; p/n identification; N/A N/A N/A
4 3 1 12 - - - -
used tote bins
Tubing Specification Incorrect length of tubing Assembly issues N/A Miss-labelling of tubing GMP, 10095161, 10021625 N/A N/A N/A
4 3 1 12 - - - -
tote bins
Tubing Specification Incorrect length of tubing Kinking N/A Miss-labelling of tubing Training, 10095161 GMP N/A N/A N/A
7 3 1 21 - - - -
tote bins
Process task Tube put on incorrect O2 mixing will not function N/A Process operative error Training, 10095161 N/A N/A N/A
8 10 1 80 - - - -
connection
Process task Ty Wrap not fitted O2 leaks N/A Process operative error Training, 10095161. Check added to N/A N/A N/A
7 10 1 70 - - - -
procedure
Process task Tube placed on incorrect O2 mixing will not function N/A Process operative error Training, 10095161 N/A N/A N/A
8 10 1 80 - - - -
connection
Process task Threaded cap not fitted O2 leaks N/A Process operative error Training, 10095161 Check added to N/A N/A N/A
7 10 1 70 - - - -
procedure
Process task Collar / Ferrite Wiring pinched/crushed N/A Process operative error Training, 10095161. Check added to N/A N/A N/A
7 10 1 70 - - - -
procedure
Lower Housing II Lower Housing II Process task Storage of fans Fan balancing compromised N/A Storage inappropriate Stored unsegregated, in tote Totes with compartments to be sourced N/A N/A
(PB560 Assy (PB560 Assy
Procedure 10095161) Procedure 10095161) 8 2 1 16 - - - -

Process task Fan positioned upside down Fan will not function as N/A Process operative error Training, 10095161, 10038461. Check ALARP - Review PFMEA as part of G- PB560 Reviewed historical failure
efficiently as it should. added to procedure QAP056. Review failure rate for internal Manufacturing yield data and PFMEA for
temperature and customer complaint rate for Engineer. PB540. Based on this
5 10 2 100 evidence of occurance. Revise occurance data, reduce occurrence 5 4 2 40
rating accordingly. rate in line with PB540

Process task Fan positioned with cable Will not assemble N/A Process operative error Training, 10095161 N/A N/A N/A
8 10 1 80 - - - -
exiting incorrectly

Page 7 of 21 10037310U00
 Process FMEA for PB560

S
e
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O D S O D R
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CTQ CTS Process Function Process Step Key Process Input Potential Failure Mode Potential Failure Effects Hazard Tag r Potential Causes C Current Controls E Actions Recommended Resp. Actions Taken E C E P
N
i C T V C T N
t
y

How often does cause or

FM occur?

cause or FM?
Critical to Critical to Safety: Operation Name for Description of step What is the Key Process In what ways does the Key What is the impact on the Key Unique Identifier for the How What causes the Key What are the existing controls and What are the actions for reducing the Whose What are the completed

How well can you detect

Quality Risk documents listed Manufacturing task within operation Input? Input go wrong? Output Variables (Customer hazard severity Input to go wrong? procedures (inspection and test) that occurrence of the Cause, or improving Responsible for actions taken with the
in this column must Requirements) or internal effects prevent either the cause or the Failure detection? Should have actions only on the recalculated RPN? Be
be reviewed prior to requirements? the Mode? Should include an SOP high RPN's or easy fixes. recommended sure to include
making any changes process number. action? completion month/year
to procedures in Key
Process Input or
Current Controls

Process task kinked cable noise N/A incorrect installation Operator training N/A N/A N/A
4 2 2 16 - - - -
storage
Torque Driver Torque too high Lower enclosure threading will N/A Torque driver is Calibration Procedure; if tool dropped, N/A N/A N/A
not torque incorrect set. CAL Lab are notified etc as per
10095161; If torque is too high, plastic
4 1 threading will be shredded and torque 3 12 - - - -
tool will not 'click' (indication of torque
level achieved).
Torque Driver Torque too low Fan could shake loose N/A Torque driver is Calibration Procedure; if tool dropped, N/A N/A N/A
8 incorrect set. 1 CAL Lab are notified etc as per 3 24 - - - -
10095161. Check in procedure
Process task Enclosure cracks where Fan could shake loose N/A Screw Hole in Check for crack added to mainline N/A N/A N/A
screw is inserted. 8 enclosure is incorrectly 2 procedure 10095161 3 48 - - - -
sized.
Process task Card mis-orientated Will not assemble N/A Process operative error Training, 10095161 N/A N/A N/A
4 10 1 40 - - - -
Torque Driver Torque too high Damage to card stop N/A Torque driver is Calibration Procedure; if tool dropped, N/A N/A N/A
incorrect set. CAL Lab are notified etc as per
10095161; If torque is too high, plastic
8 1 threading will be shredded and torque 3 24 - - - -
tool will not 'click' (indication of torque
level achieved).
Torque Driver Torque too low Card stop could shake loose N/A Torque driver is Calibration Procedure; if tool dropped, N/A N/A N/A
8 incorrect set. 1 CAL Lab are notified etc as per 6 48 - - - -
10095161. Check in procedure
Process task Do not insert the power Will not assemble N/A Process operative error Training, 10095161 N/A N/A N/A
4 10 1 40 - - - -
card rear first
Process task Do not attach fan Unit will run hot N/A Process operative error Product SW will detect if fan is not N/A N/A N/A
connected "COOLING FAN FAILURE";
8 10 Training,10095161, 10038461. DHR has 1 80 - - - -
specific check.
Handling of PCBA Warpage of Power supply component failure N/A poor handling/tool Operator training N/A N/A N/A N/A N/A N/A N/A
PCBA board slippage
8 1 storage 2 16
dropping of the board
Torque Driver Torque too high Damage to power card N/A Torque driver is Calibration Procedure; if tool dropped, N/A N/A N/A
(PCBA) incorrect set. CAL Lab are notified etc as per
10095161; If torque is too high, plastic
8 1 threading will be shredded and torque 3 24 - - - -
tool will not 'click' (indication of torque
level achieved).
Torque Driver Torque too low Power card (PCBA) could N/A Torque driver is Calibration Procedure; if tool dropped, N/A N/A N/A
shake loose incorrect set. CAL Lab are notified etc as per
7 1 10095161; connection is used during test 4 28 - - - -
process; unit is serviced periodically in
the field;
Final Assembly Final Assembly Process task Do not connect silicone Unit will fail test N/A Process operative error Training, 10095163; 10036007, N/A N/A N/A
(PB560 Assy (PB560 Assy tubing 10039030. Specific checks in procedure
Procedure 10095163) Procedure 10095163) 8 10 1 80 - - - -

Process task Do not connect Power Unit will fail test N/A Process operative error Training, 10095163; 10036007, N/A N/A N/A
Supply Blower Harness fully 8 10 10039030 1 80 - - - -

Process task Do not connect tubing from Unit will fail test N/A Process operative error Training, 10095163 10036007, 10039030 N/A N/A N/A
8 10 1 80 - - - -
O2 valve fully
Process task Do not connect cable tie O2 leaks N/A Process operative error Training, 10095163 Check on DHR N/A N/A N/A
5 10 1 50 - - - -
Process task Do not connect cable tie O2 tube becomes N/A Process operative error Training, 10095163; 10036007, N/A N/A N/A
4 10 1 40 - - - -
disconnected. Unit will fail. 10039030
Process task Catch cables with blower Damage wiring N/A Process operative error CAUTION Note contained in PI ALARP - Review PFMEA and test procedure to PB560 N/A
E:\Update PFMEA assembly 8 10 10095163. 2 160 determine if RPN score can be reduced further. Manufacturing - - - -
24Oct08\FMECA_LR0001.DOC
Revise occurance rating accordingly. Engineer.
Process task Do not connect cables to Unit will fail test N/A Process operative error Training, 10095163; 10036007, N/A N/A N/A
8 10 1 80 - - - -
buzzer card fully 10039030
Process task Do not connect the tubing Unit will fail test or come loose N/A Process operative error Training, 10051250; 10036007, N/A N/A N/A
8 10 1 80 - - - -
E:\Upda te PFMEA
24O ct08\FMEC A_LR 000 2. DOC

correctly in field over time 10039030

Process task Do not fit ferrite to FiO2 Unit could be succeptable to N/A Process operative error Training, 10095163 ALARP - Change sequence of assembly to Sean Knight Updated mainline
cable emissions. 8 10 5 400 include ferrite during sub assembly. Add check procedure. Ref ECO- 8 5 1 40
to DHR. R180705
Process task Pinch FiO2 cable in ferrite Unit will not have FiO2 N/A Process operative error Training,10095163; 10036007, 10039030 N/A N/A N/A
5 10 1 50 - - - -
functionality
Process task FiO2 wire is not wound Unit could be succeptable to N/A Process operative error Training, 10095163 ALARP - Change sequence of assembly to Sean Knight Updated mainline
around ferrite emissions. 8 10 5 400 include ferrite during sub assembly. Add procedure. Ref ECO- 8 5 1 40
instruction regarding routing cables. R180705
Process task FiO2 wire is left too long Unit could be succeptable to N/A Process operative error Training, 10095163 ALARP - Change sequence of assembly to Sean Knight Updated mainline
between J5 and ferrite emissions. 8 10 5 400 include ferrite during sub assembly procedure. Ref ECO- 8 5 1 40
R180705
Process task FiO2 wire is left too short Connection J5 cannot be N/A Process operative error Training, 10095161 N/A N/A N/A
4 10 1 40
between J5 and ferrite made
Process task Tubing gets pinched Unit will fail test N/A Process operative error Training, 10095163 10036007, 10039030 N/A N/A N/A
7 10 1 70 - - - -

Page 8 of 21 10037310U00
 Process FMEA for PB560

S
e
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O D S O D R
e P
CTQ CTS Process Function Process Step Key Process Input Potential Failure Mode Potential Failure Effects Hazard Tag r Potential Causes C Current Controls E Actions Recommended Resp. Actions Taken E C E P
N
i C T V C T N
t
y

How often does cause or

FM occur?

cause or FM?
Critical to Critical to Safety: Operation Name for Description of step What is the Key Process In what ways does the Key What is the impact on the Key Unique Identifier for the How What causes the Key What are the existing controls and What are the actions for reducing the Whose What are the completed

How well can you detect

Quality Risk documents listed Manufacturing task within operation Input? Input go wrong? Output Variables (Customer hazard severity Input to go wrong? procedures (inspection and test) that occurrence of the Cause, or improving Responsible for actions taken with the
in this column must Requirements) or internal effects prevent either the cause or the Failure detection? Should have actions only on the recalculated RPN? Be
be reviewed prior to requirements? the Mode? Should include an SOP high RPN's or easy fixes. recommended sure to include
making any changes process number. action? completion month/year
to procedures in Key
Process Input or
Current Controls

Torque Driver Torque too high Damage to card. N/A Torque driver is Calibration Procedure; if tool dropped, N/A N/A N/A
incorrect set. CAL Lab are notified etc as per
10095161, 10095162, 10095163; If
8 1 torque is too high, plastic threading will 3 24 - - - -
be shredded and torque tool will not 'click'
(indication of torque level achieved).

Torque Driver Torque too low Card could shake loose N/A Torque driver is Calibration Procedure; if tool dropped, N/A N/A N/A
incorrect set. CAL Lab are notified etc as per
7 1 10095161, 10095162, 10095163; 4 28 - - - -
connection is used during test process;
unit is serviced periodically in the field;
Process task Do not connect O2 valve Unit will fail test N/A Process operative error Training, 10095163; 10036007, N/A N/A N/A
8 10 1 80 - - - -
10039030
Process task Do not connect SPO2 valve Unit will fail test N/A Process operative error Training, 10095163 10036007, 10039030 N/A N/A N/A
8 10 1 80 - - - -
Process task Do not connect alarm Unit will fail test N/A Process operative error Training, 10095163; 10036007, N/A N/A N/A
8 10 1 80 - - - -
repeater harness 10039030
Process task Do not connect buzzer Unit will fail test N/A Process operative error Training, 10095163 10036007, 10039030 N/A N/A N/A
8 10 1 80 - - - -
connection
Process task Do not connect power cord Unit will fail test N/A Process operative error Training, 10095163 10036007, 10039030 N/A N/A N/A
8 10 1 80 - - - -
Process task Do not connect blower Unit will fail test N/A Process operative error Training, 10051250; 10036007, N/A N/A N/A
8 10 1 80 - - - -
connection. 10039030
Process task Put foam in backwards Harder to see if the filter is N/A Process operative error PI specifies to mount black side of foam N/A N/A N/A
dirty 3 10 toward inside of unit. Specific check in 1 30 - - - -
procedure
Process task Do not connect keypad Unit will fail test N/A Process operative error Training, 10095163; 10036007, N/A N/A N/A
8 10 1 80 - - - -
10039030
Process task Do not lock keypad flex tail Unit will operate intermittently N/A Process operative error Training, 10095163; 10036007, N/A N/A N/A
8 10 1 80 - - - -
connection 10039030. Specific checks in procedure
Process task Pinch keypad cable in Prevent functionality of keypad N/A Process operative error Training, 10095163; 10036007, N/A N/A N/A
enclosure / keyboard. Fail test. Keyboard 10039030
Flex Tail Track(s) can be 8 10 1 80 - - - -
broken / damaged.
Torque Driver Torque too high Damage to enclosure. N/A Torque driver is Calibration Procedure; if tool dropped, N/A N/A N/A
incorrect set. CAL Lab are notified etc as per
10095161,10095162 & 10095163. If
6 1 torque is too high, plastic threading will 3 18 - - - -
be shredded and torque tool will not 'click'
(indication of torque level achieved).

Torque Driver Torque too low Enclosure could shake loose N/A Torque driver is Calibration Procedure; if tool dropped, N/A N/A N/A
incorrect set. CAL Lab are notified etc as per
7 1 10095161,10095162 & 10095163; 4 28 - - - -
connection is used during test process;
unit is serviced periodically in the field;
Process task Loose screw left in vent Screw could short an electrical N/A Operator accidently Training, 10095163, screws are inserted N/A N/A N/A
assembly. circuit. 8 drops screw from 10 one at a time. 1 80
screwdriver.
Process task Screw becomes loose and Screw could short an electrical N/A Torque driver is Calibration Procedure; if tool dropped, N/A N/A N/A
free to move within unit. circuit. 8 incorrect set. 1 CAL Lab are notified etc as per 6 48
10095163
Mount the Battery Mount the Battery Process task Insert battery incorrectly Unit will fail test N/A Process operative error Training, 10095163; 10036007, N/A N/A N/A
(PB560 Assy (PB560 Assy 10039030
Procedure 10051250 Procedure 10051250 8 10 1 80 - - - -

Torque Driver Torque too high Damage to battery cover. N/A Torque driver is Calibration Procedure; if tool dropped, N/A N/A N/A
incorrect set. CAL Lab are notified etc as per
10095161,10095162 & 10095163; If
8 1 torque is too high, plastic threading will 3 24 - - - -
be shredded and torque tool will not 'click'
(indication of torque level achieved).

Torque Driver Torque too low Cover could shake loose N/A Torque driver is Calibration Procedure; if tool dropped, N/A N/A N/A
incorrect set. CAL Lab are notified etc as per
7 1 10095161,10095162 & 10095163; 4 28 - - - -
connection is used during test process;
unit is serviced periodically in the field;
Process task Do not fit the cable restraint. Mains cable could become N/A Process operative error Training, 10095163 N/A N/A N/A
4 10 1 40 - - - -
disconnected.
Hipot Test Hipot Test PB500 ELECTRICAL Procedures misinterpreted Hipot test is not executed N/A Lack of review of Procedure is ECO controlled in Agile; ALARP - Review PFMEA and test procedure PB560 Reviewed historical failure
SAFETY TEST & due lack of clarity; correctly or unsafely procedure Process is validated - LR0005; as part of G-QAP056. Review procedure vs Manufacturing yield data and PFMEA for
BUZZER CARD CHARGE incorrectly written practice. Revise occurance rating accordingly. Engineer. PB540. Based on this
PROCEDURE - 9 10 1 90 data, reduce occurrence 9 2 1 18
10076002 rate in line with PB540

Operator: Operator: does not follow Hipot test is not executed N/A Operator doesn't follow Operator trained and signed off on ALARP - Review PFMEA as part of G- PB560 Reviewed historical failure
test procedure correctly correctly or unsafely procedure - cables not procedure per G-QAP017. Test QAP056. Review procedure vs practice. Manufacturing yield data and PFMEA for
connected per setup instrument is automated with Pass/Fail Revise occurance rating accordingly. Engineer. PB540. Based on this
9 10 result and test will fail if the hipot or 1 90 data, reduce occurrence 9 5 1 45
ground cable is not connected rate in line with PB540

Page 9 of 21 10037310U00
 Process FMEA for PB560

S
e
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O D S O D R
e P
CTQ CTS Process Function Process Step Key Process Input Potential Failure Mode Potential Failure Effects Hazard Tag r Potential Causes C Current Controls E Actions Recommended Resp. Actions Taken E C E P
N
i C T V C T N
t
y

How often does cause or

FM occur?

cause or FM?
Critical to Critical to Safety: Operation Name for Description of step What is the Key Process In what ways does the Key What is the impact on the Key Unique Identifier for the How What causes the Key What are the existing controls and What are the actions for reducing the Whose What are the completed

How well can you detect

Quality Risk documents listed Manufacturing task within operation Input? Input go wrong? Output Variables (Customer hazard severity Input to go wrong? procedures (inspection and test) that occurrence of the Cause, or improving Responsible for actions taken with the
in this column must Requirements) or internal effects prevent either the cause or the Failure detection? Should have actions only on the recalculated RPN? Be
be reviewed prior to requirements? the Mode? Should include an SOP high RPN's or easy fixes. recommended sure to include
making any changes process number. action? completion month/year
to procedures in Key
Process Input or
Current Controls

Test Equipment: Hipot Test Equipment: Hipot Hipot test is not executed N/A Hipot Tester Process is validated - LR0005; N/A N/A N/A
Tester Tester does not test unit correctly malfunction or out of Equipment is on a calibration schedule.
properly or has the incorrect 9 calibration 4 Hipot tester settings are checked on a 1 36 - - - -
voltage/trip current settings daily basis before use and recorded on
log 10060262.
Test Equipment: Hipot Test Equipment: Hipot Hipot test is not executed N/A broken wire in cable Cables are checked on a daily basis ALARP - Review PFMEA as part of G- PB560 Reviewed historical failure
Tester cables Tester cables are open correctly - potential shock before use and test will fail if the hipot or QAP056. Review procedure vs practice. Manufacturing yield data and PFMEA for
circuit hazard ground cable is not connected or broken. Revise occurance rating accordingly. Engineer. PB540. Based on this
9 10 Preventive Maintenance G-AMFG-1180- 1 90 data, reduce occurrence 9 4 1 36
00 inspects Hipot cable assy rate in line with PB540

Leakage Current Leakage Current PB500 ELECTRICAL Procedures misinterpreted Leakage Current test is not N/A Lack of review of Procedure is ECO controlled in Agile; N/A N/A N/A
Tests Tests SAFETY TEST & due lack of clarity; executed correctly or unsafely procedure Process is validated - LR0005;
BUZZER CARD CHARGE incorrectly written 6 10 1 60 - - - -
PROCEDURE -
10076002
Operator Operator: does not follow Leakage Current tests are not N/A Operator doesn't follow Operator trained and signed off on N/A N/A N/A
test procedure correctly executed correctly procedure - does not procedure per G-QAP017. Test is
connect cables per automated, but needs cables connected
6 setup 10 properly. Hipot test should catch any 1 60 - - - -
gross enclosure leakage faults which
would be seen at the USB connectors
Test Equipment:Safety Test Equipment: Safety Leakage Current tests are not N/A Safety Analyzer Tester Process is validated - LR0005; N/A N/A N/A
Analyzer Tester Analyzer Tester does not executed correctly malfunction or out of Equipment is on a calibration schedule.
test unit properly or has the 6 calibration. 10 Settings are stored in the tester unit and 1 60 - - - -
incorrect settings recalled each time the unit is turned on.

Test Equipment: Safety Test Equipment: Safety Leakage Current tests are not N/A Broken wire in cable Cables are checked for continuity on a N/A N/A N/A
Analyzer Tester cables Analyzer Tester cables are executed correctly 6 10 daily basis before use 1 60 - - - -
open circuit
Software Download Software Download Procedure: PB560, Procedures misinterpreted Software is not downloaded or N/A Lack of review of Procedure is ECO controlled in Agile; N/A N/A N/A
incl Battery Patch incl Battery Patch Calibration and Test - P/N due lack of clarity; verified to be downloaded procedure process is validated - LR0005;
Download Download 10036007 incorrectly written correctly Successful download message is
checked when download is complete.
6 10 Test process will not execute successfully 1 60 - - - -
without product software loaded and S/W
version are recorded on DHR later in
procedure

Operator Operator: does not follow Operator does not complete N/A Operator doesn't follow Operator trained and signed off on N/A N/A N/A
test procedure product software download procedure - power procedure per G-QAP017. Process is
successfully switch in wrong position validated - LR0005; Successful download
for ST10 download, message is checked when download is
6 wrong com port 10 complete. Download app cannot start 1 60 - - - -
selected for either with wrong com port number. Test
download app, process will not execute successfully
download cable not without product software loaded
connected

Test Equipment: Cable: download cable Software download does not N/A Cable is worn or broken Process is validated - LR0005; N/A N/A N/A
Download cable, USB shorted or open circuit execute from use Download cannot start with bad cable.
Type A/ Mini B Test process will not run without product
software loaded. Download cable can be
4 2 replaced with off the self spare. 3 24 - - - -
Preventive Maintenance G-AMFG-1180-
00 inspects download cable

Test Equipment: Test Equipment: Download Software download does not N/A PC software is corrupt Process is validated - LR0005; N/A N/A N/A
Download PC PC does not function execute or PC hardware Successful download message when
properly - download app problem download is complete and S/W version is
does not run 4 2 recorded on DHR later in procedure. 3 24 - - - -
Test process will not run without product
software loaded. PC can be replaced
with any spare.

Product Software Product Software is not the Vent has incorrect version of N/A Download PC has Process is validated - LR020. Product N/A N/A N/A
CPU: p/n 10039034 correct version software loaded relevant software in software is ECO controlled/released.
Power: p/n 3832100 4 incorrect file location. 2 Product s/w version is recorded on DHR 2 16 - - - -
later in procedure.
Operator PB540/PB520 CPU S/W is Vent has incorrect software N/A Incorrect file path is CPU software version is hand written on N/A N/A N/A
loaded instead of the loaded chosen at download. DHR. Operator must record downloaded
PB560S/W version and verify against the version
4 3 printed on the DHR 2 24 - - - -

Operator Incorrect CPU software is vent has incorrect software N/A Incorrect file path is Openvent software at final test will look N/A N/A N/A
loaded on vent chosen at download. for correct PB560 vent serial number.
4 3 2 24 - - - -

Operator Incorrect version Power Generic Power management N/A Universal PIC, Power Process validated as per LR0017. PIC N/A N/A N/A
Management Board S/W is software for PB500 units management software software (power management) will be
loaded recorded and verified by operator.
1 1 1 1 - - - -

Page 10 of 21 10037310U00
 Process FMEA for PB560

S
e
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O D S O D R
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CTQ CTS Process Function Process Step Key Process Input Potential Failure Mode Potential Failure Effects Hazard Tag r Potential Causes C Current Controls E Actions Recommended Resp. Actions Taken E C E P
N
i C T V C T N
t
y

How often does cause or

FM occur?

cause or FM?
Critical to Critical to Safety: Operation Name for Description of step What is the Key Process In what ways does the Key What is the impact on the Key Unique Identifier for the How What causes the Key What are the existing controls and What are the actions for reducing the Whose What are the completed

How well can you detect

Quality Risk documents listed Manufacturing task within operation Input? Input go wrong? Output Variables (Customer hazard severity Input to go wrong? procedures (inspection and test) that occurrence of the Cause, or improving Responsible for actions taken with the
in this column must Requirements) or internal effects prevent either the cause or the Failure detection? Should have actions only on the recalculated RPN? Be
be reviewed prior to requirements? the Mode? Should include an SOP high RPN's or easy fixes. recommended sure to include
making any changes process number. action? completion month/year
to procedures in Key
Process Input or
Current Controls

Download Software p/n Download Software Software download fails N/A unexpected software Process is validated - LR0005; N/A N/A N/A
3832500 and 3832600 performs download fault Successful download message is
incorrectly checked when download is complete.
4 2 Product S/W version is recorded on DHR 3 24 - - - -
later in procedure. Test process will not
execute successfully without product
software loaded

Download Software p/n Download Software is not Software download may not N/A specific to reason for Process is validated - LR0005. Download N/A N/A N/A
3832500 and 3832600 the correct version work as expected (specific to update software is ECO controlled/realeased. A
reason for update) validation process is performed with
4 2 update of download software. Product 3 24 - - - -
S/W version is recorded on DHR later in
procedure.

Operator Battery Patch Software is Battery Capacity Check will N/A Operator does not Operator trained and signed off on N/A N/A N/A
not downloaded per fail if the Battery Patch s/w complete download procedure per G-QAP017. If not caught
procedure download was required. 6 successfully 4 at the Battery Capacity Check, may also 2 48 - - - -
fail the Battery Discharge-Charge Cycle
Testing
Check Power Up Check Power Up Procedure: PB560, Procedures misinterpreted Power Up indicators are not N/A Lack of review of The AC Led is also checked in Power ALARP - Review PFMEA as part of G- PB560 Reviewed historical failure
Indicators Indicators Calibration and Test - P/N due lack of clarity; checked correctly procedure Source Switching test, the Yellow alarm QAP056. Review procedure vs practice. Manufacturing yield data and PFMEA for
10036007 incorrectly written led is also checked in the Remote Alarm Revise occurance rating accordingly. Engineer. PB540. Based on this
test and the Red alarm led is also data, reduce occurrence
checked in the Patient Disconnect Test of rate in line with PB540
the 10036007 test procedure. The two
6 10 2 120 6 2 2 24
buzzers are also checked in the
10036007 test proc. Procedure is ECO
controlled in Agile; Process is validated -
LR0005; operator trained and signed off
on procedure

Operator Operator: does not follow Power Up indicators are not N/A Operator doesn't follow Operator trained and signed off on ALARP - Review PFMEA as part of G- PB560 Reviewed historical failure
test procedure checked to test procedure procedure - operator procedure per G-QAP017. The AC Led QAP056. Review procedure vs practice. Manufacturing yield data and PFMEA for
does not verify all and is also checked in Power Source Revise occurance rating accordingly. Engineer. PB540. Based on this
indicators Switching test, the yellow alarm led is data, reduce occurrence
also checked in the Remote Alarm test rate in line with PB540
6 10 and the Red alarm led is also checked in 2 120 6 6 2 72
the Patient Disconnect Test of the
10036007 test procedure. The two
buzzers are also checked in the
10036007 test proc.

Set Vent S/N Set Vent S/N Procedure: PB560, Procedures misinterpreted Vent has wrong or no S/N N/A Lack of review of S/N written is verified later in procedure, N/A N/A N/A
Calibration and Test - P/N due lack of clarity; stored procedure Procedure is ECO controlled in Agile;
10036007 incorrectly written 2 10 Process is validated - LR0004/LR0005; 2 40 - - - -
operator trained and signed off on
procedure
Operator Operator: does not enter Vent has wrong S/N stored N/A Operator doesn't follow S/N written is verified later in procedure, N/A N/A N/A
S/N correctly procedure - enters operator trained and signed off on
wrong S/N or does not procedure per G-QAP017.
2 click Ecruiture S/N to 10 2 40 - - - -
store serial number

Setup Time/Date Setup Time/Date Procedure: PB560, Procedures misinterpreted Time/date not written to N/A Lack of review of Time/date written verified later in Review PFMEA as part of G-QAP056. Review PB560 Reviewed historical failure
Calibration and Test - P/N due lack of clarity; ventilator procedure procedure, Procedure is ECO controlled procedure vs practice. Revise occurance rating Manufacturing yield data and PFMEA for
10036007 incorrectly written in Agile; Process is validated - LR0005; accordingly. Engineer. PB540. Based on this
5 10 2 100 data, reduce occurrence 5 2 2 20
rate in line with PB540

Operator Operator: does not enter Wrong time or date entered to N/A Operator doesn't follow Time/date is written verified later in Review PFMEA as part of G-QAP056. Review PB560 Reviewed historical failure
time or date correctly vent procedure - wrong time procedure, operator trained and signed procedure vs practice. Revise occurance rating Manufacturing yield data and PFMEA for
and/or date entered off on procedure per G-QAP017. accordingly. Engineer. PB540. Based on this
5 10 2 100 data, reduce occurrence 5 5 2 50
rate in line with PB540

Record Software Record Software Operator Operator: does not record Test not executed correctly - N/A Operator doesn't follow Procedure is ECO controlled in Agile; N/A N/A N/A
Versions Versions software version numbers incorrect software s/n's procedure - wrong Process is validated - LR0005; operator
as displayed on ventilator recorded 1 number recorded - typo 10 trained and signed off on procedure per 2 20 - - - -
screen errors G-QAP017.
Check Vent S/N Check Vent S/N Operator Operator: does not check Test not executed correctly - N/A Operator doesn't follow Operator trained and signed off on N/A N/A N/A
that the ventilator S/N potential for missed faults procedure - comparison procedure per G-QAP017. Checked in
stored matches the DHR 1 made incorrectly 10 Product Authorisation Release 2 20 - - - -
correctly
Remote Alarm Tests Remote Alarm Tests Procedure: PB560, Procedures misinterpreted Remote Alarm is not checked N/A Lack of review of Procedure is ECO controlled in Agile; N/A N/A N/A
Calibration and Test - P/N due lack of clarity; correctly 6 procedure 10 Process is validated - LR0005; 1 60 - - - -
10036007 incorrectly written
Operator Operator: does not follow Remote Alarm is not checked N/A Operator doesn't follow The normally closed and open Remote Review PFMEA as part of G-QAP056. Review PB560 Reviewed historical failure
procedure correctly to test procedure correctly procedure - does not Alarm Contacts are checked using a procedure vs practice. Check customer Manufacturing yield data and PFMEA for
verify all indicators or DVM for continuity in both the complaint rates. Revise occurance rating Engineer. PB540. Based on this
6 the DVM continuity 10 deactivated and activated positions and 2 120 accordingly. data, reduce occurrence 6 2 2 24
checks recorded on DHR. Operator trained and rate in line with PB540
signed off on procedure per G-QAP017.

Test Equipment: Patient Patient Connector Ventilator producing N/A Patient Connector Process is validated - LR0005; N/A N/A N/A
Connector Assembly #1 Assembly #1 hoses leaking unexpected alarms causing Assembly #1 has Preventive Maintenance Procedure G-
air confusion when checking 1 broken air hoses or 5 AMFG-1180-00 inspects tubing/fitting 3 15 - - - -
expected alarms fittings

Page 11 of 21 10037310U00
 Process FMEA for PB560

S
e
v R
O D S O D R
e P
CTQ CTS Process Function Process Step Key Process Input Potential Failure Mode Potential Failure Effects Hazard Tag r Potential Causes C Current Controls E Actions Recommended Resp. Actions Taken E C E P
N
i C T V C T N
t
y

How often does cause or

FM occur?

cause or FM?
Critical to Critical to Safety: Operation Name for Description of step What is the Key Process In what ways does the Key What is the impact on the Key Unique Identifier for the How What causes the Key What are the existing controls and What are the actions for reducing the Whose What are the completed

How well can you detect

Quality Risk documents listed Manufacturing task within operation Input? Input go wrong? Output Variables (Customer hazard severity Input to go wrong? procedures (inspection and test) that occurrence of the Cause, or improving Responsible for actions taken with the
in this column must Requirements) or internal effects prevent either the cause or the Failure detection? Should have actions only on the recalculated RPN? Be
be reviewed prior to requirements? the Mode? Should include an SOP high RPN's or easy fixes. recommended sure to include
making any changes process number. action? completion month/year
to procedures in Key
Process Input or
Current Controls

CTQ Power Source Power Source Procedure: PB560, Procedures misinterpreted Power Source switching is not N/A Lack of review of Procedure is ECO controlled in Agile; N/A N/A N/A
Switching Tests Switching Tests Calibration and Test - P/N due lack of clarity; checked correctly 6 procedure 2 Process is validated - LR0005; 2 24 - - - -
10036007 incorrectly written
Operator Operator: does not follow Power Source switching is not N/A Operator doesn't follow Operator trained and signed off on ALARP - Review PFMEA as part of G- PB560 Reviewed historical failure
test procedure checked to test procedure procedure - setup procedure per G-QAP017. DHR QAP056. Review procedure vs practice. Check Manufacturing yield data and PFMEA for
correctly incorrect or makes 10038461 includes all checks performed customer complaint rates. Revise occurance Engineer. PB540. Based on this
power supply in procedure. Measurements checked rating accordingly. data, reduce occurrence
6 adjustment- 10 against limits in Product Authorisation 2 120 rate in line with PB540 6 2 2 24
measurements Release. Power Management board has
incorrectly passed similar tests for power switching
in functional test

Operator Operator: the power supply External DC Power Supply N/A Operator doesn't follow Test procedure contains steps to ALARP - Review PFMEA as part of G- PB560 Reviewed historical failure
is adjusted too fast reading recorded is not the procedure - makes increment/decrement power supply by QAP056. Review procedure vs practice. Check Manufacturing yield data and PFMEA for
correct value or there is not power supply 0.1V steps, then stop and observe for customer complaint rates. Revise occurance Engineer. PB540. Based on this
uniformity of testing between adjustment too fast power led change. Operator trained and rating accordingly. data, reduce occurrence
test operators signed off on procedure per G-QAP017. rate in line with PB540
6 10 Measurements checked against limits in 2 120 6 4 2 48
Product Authorisation Release. Power
Management board has passed similar
tests for power switching in functional test

Test Equipment: External External DC Adjustable Power Source switching is not N/A External DC Adjustable Process is validated - LR0005; N/A N/A N/A
DC Adjustable Power Power Supply output is out checked to test procedure Power Supply out of Equipment is on a calibration schedule.
Supply of spec, or not displaying correctly - false test failures or 6 calibration or faulty 4 Spare PS available 3 72 - - - -
voltage accurately missed faults
Test Equipment: Test DC Test DC Power Cable, P/N Power Source switching is not N/A Broken wire in cable Preventive Maintenance Procedure G- N/A N/A N/A
Power Cable, P/N 10022945 is broken checked to test procedure AMFG-1180-00 inspects DC power cable.
10022945 correctly - false test failures 5 4 Process is validated - LR0005; 2 40 - - - -

CTQ Alarm tests Alarm tests Procedure: PB560, Procedures misinterpreted Alarm tests not executed N/A Lack of review of Procedure is ECO controlled in Agile; ALARP - Review PFMEA as part of G- PB560 Reviewed historical failure
Calibration and Test - P/N due lack of clarity; correctly procedure Process is validated - LR0004/LR0005; QAP056. Review procedure vs practice. Manufacturing yield data and PFMEA for
10036007 incorrectly written Revise occurance rating accordingly. Engineer. PB540. Based on this
7 10 2 140 data, reduce occurrence 7 2 2 28
rate in line with PB540

Operator Operator: does not follow Alarm tests not executed to N/A Operator doesn't follow DHR 10038461 includes checks to be ALARP - Review PFMEA as part of G- PB560 Reviewed historical failure
test procedure test procedure correctly - procedure - checks for performed. Operator trained and signed QAP056. Review procedure vs practice. Check Manufacturing yield data and PFMEA for
potential for missed faults leds, alarm sound and off on procedure per G-QAP017. customer complaint rates. Revise occurance Engineer. PB540. Based on this
7 duration not verified 10 Measurement checked against limits in 2 140 rating accordingly. data, reduce occurrence 7 5 2 70
correctly Product Authorisation Release. rate in line with PB540

Test Equipment: Sound The Alarm sound level is Alarm tests not executed N/A Sound level meter is Process is validated - LR0004/LR0005; N/A N/A N/A
Level Meter reading incorrectly correctly - potential for missed out of calibration Equipment is on a calibration schedule,
faults or false failues 7 1 Sound Level Meter is checked on a daily 2 14 - - - -
basis and recorded on log 10039028

SPKR FAULT1 or SPKR The buzzer battery is not False failure for the N/A The buzzer battery is Procedure is ECO controlled in Agile; N/A N/A N/A
FAULT4 alarm events sufficently charged for the Involuntary Alarm Test not sufficently charged Process is validated - LR0004/LR0005;
test for the test 10036007 test proc has test note to
6 4 insure vent is switched on for at least 15 3 72 - - - -
minutest to permit ample charging of the
buzzer battery before performing the
Involuntary Stop Alarm Test

Operator Exhalation Valve Alarm Exhalation Valve Alarm test is N/A PB560 Vent settings Procedure is ECO controlled in Agile; ALARP - Review PFMEA as part of G- PB560 No non value type
does not sound as not executed correctly are not set correctly to Process is validated - LR0004/LR0005. QAP056. Review procedure vs practice. Check Manufacturing configuration used in this
expected in test be in a valve type Vent settings are specifically stated in customer complaint rates. Revise occurance Engineer. process. Reviewed
7 configuration per 10 procedure to insure vent will inidcate an 2 140 rating accordingly. procedure vs. practice 7 4 2 56
procedure Exhalation Valve Alarm during validation build. No
occurrence detected
during the build.

USB Ports Test USB Ports Test Procedure: PB560, Procedures misinterpreted USB not functioning N/A Lack of review of Procedure is ECO controlled in Agile; ALARP - Review PFMEA as part of G- PB560 No impact on ventilation
Calibration and Test - P/N due lack of clarity; procedure Process is validated - LR0005; QAP056. Review procedure vs practice. Check Manufacturing funciton. USB port used
10036007 incorrectly written customer complaint rates. Revise occurance Engineer. only for downloading logs.
rating accordingly. Reviewed practice vs.
6 10 2 120 procedure during 4 5 2 40
validation build. No
occurrence detected
during the build.

Operator Operator: does not follow USB not functioning N/A Operator doesn't follow Operator trained and signed off on Review PFMEA as part of G-QAP056. Review PB560 No impact on ventilation
test procedure correctly. procedure - both ports procedure per G-QAP017. 10038461 procedure vs practice. Check customer Manufacturing funciton. USB port used
USB Memory Device is not are not tested DHR has check boxes to indicate each complaint rates. Revise occurance rating Engineer. only for downloading logs.
inserted into both ports port is tested accordingly. Reviewed practice vs.
6 10 2 120 procedure during 4 5 2 40
validation build. No
occurrence detected
during the build.

Test Equipment - USB USB Device has an fault or Vent does not recognise the N/A USB Device has an Process is validated - LR0005; USB N/A N/A N/A
Memory Device is not formatted to the USB memory device fault or is not formatted Memory device can be easily checked on
FAT32 format 6 the the FAT32 format 2 any PC 3 36 - - - -

Page 12 of 21 10037310U00
 Process FMEA for PB560

S
e
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O D S O D R
e P
CTQ CTS Process Function Process Step Key Process Input Potential Failure Mode Potential Failure Effects Hazard Tag r Potential Causes C Current Controls E Actions Recommended Resp. Actions Taken E C E P
N
i C T V C T N
t
y

How often does cause or

FM occur?

cause or FM?
Critical to Critical to Safety: Operation Name for Description of step What is the Key Process In what ways does the Key What is the impact on the Key Unique Identifier for the How What causes the Key What are the existing controls and What are the actions for reducing the Whose What are the completed

How well can you detect

Quality Risk documents listed Manufacturing task within operation Input? Input go wrong? Output Variables (Customer hazard severity Input to go wrong? procedures (inspection and test) that occurrence of the Cause, or improving Responsible for actions taken with the
in this column must Requirements) or internal effects prevent either the cause or the Failure detection? Should have actions only on the recalculated RPN? Be
be reviewed prior to requirements? the Mode? Should include an SOP high RPN's or easy fixes. recommended sure to include
making any changes process number. action? completion month/year
to procedures in Key
Process Input or
Current Controls

Calibrate Patient Calibrate Patient Procedure: PB560, Procedures misinterpreted Patient Pressure sensor not N/A Lack of review of Procedure is ECO controlled in Agile; ALARP - Review PFMEA as part of G- PB560 Reviewed historical failure
Sensor Sensor Calibration and Test - P/N due lack of clarity; calibrated correctly procedure Process is validated - LR0005; QAP056. Review procedure vs practice. Check Manufacturing yield data and PFMEA for
10036007 incorrectly written customer complaint rates. Revise occurance Engineer. PB540. Based on this
7 10 2 140 rating accordingly. data, reduce occurrence 7 2 2 28
rate in line with PB540

Operator Operator: does not follow Patient Pressure sensor not N/A Operator doesn't follow Operator trained and signed off on ALARP - Review PFMEA as part of G- PB560 Reviewed historical failure
test procedure correctly calibrated correctly procedure - pressure is procedure per G-QAP017. Presurre is QAP056. Review procedure vs practice. Check Manufacturing yield data and PFMEA for
-masurements are not not set to 40cmH20 for checked immediatley after cal and customer complaint rates. Revise occurance Engineer. PB540. Based on this
accurate calibration. verified later in Final Test Procedure. rating accordingly. data, reduce occurrence
PTS2000 is powered Measurement checked against limits in rate in line with PB540
7 on with pressure 10 Product Authorisation Release. 2 140 7 2 2 28
applied to input Procedure contains warning to not apply
pressure during power-up. PTS2000 is
not power cycled during any tesing.

Test Equipment: Patient Test Equipment: Air tubing Patient Pressure sensor not N/A Broken or cracked air Preventive Maintenance Procedure G- N/A N/A N/A
Connector Assembly #2 leaking air calibrated correctly hose AMFG-1180-00 inspects tubing/fitting.
-masurements are not 7 3 Process is validated - LR0005; Pressure 3 63 - - - -
accurate is checked in the Final Test Procedure
using different air tubing
Test Equipment: Test Equipment: PTS2000 Patient Pressure sensor not N/A PTS2000 is out of Process is validated - LR0004; N/A N/A N/A
PTS2000 is not reading accurately calibrated correctly- calibration Equipment is on a 3 month internal
measurements are not 7 1 calibration schedule and 12 month ext 3 21 - - - -
accurate calibration .
Calibrate Exhalation Calibrate Exhalation Procedure: PB560, Procedures misinterpreted Exhalation valve sensor not N/A Lack of review of Procedure is ECO controlled in Agile; ALARP - Review PFMEA as part of G- PB560 Reviewed historical failure
Valve Sensor Valve Sensor Calibration and Test - P/N due lack of clarity; calibrated correctly procedure Process is validated - LR0005; Basic QAP056. Review procedure vs practice. Check Manufacturing yield data and PFMEA for
10036007 incorrectly written Exhalation Valve opereation is checked customer complaint rates. Revise occurance Engineer. PB540. Based on this
7 10 in Final System Test 2 140 rating accordingly. data, reduce occurrence 7 2 2 28
rate in line with PB540

Operator Operator: does not follow Exhalation valve sensor not N/A Operator doesn't follow Operator trained and signed off on Update procedure & DHR to add a check to Dara O'Connor Update procedure & DHR
test procedure & updated calibrated correctly. procedure - fails without procedure per G-QAP017; Exhalation ensure the connector #2 assembly is fitted on ECO-R197243
connector assembly #2 is Measurements are not detection by missing Valve opereation is checked in Final correctly.
not fitted correctly as per accurate the long beep response System Test. Simple process with little
procedure 10036007 rev G 7 after calibration 10 possibility for operator mistakes. 2 140 7 10 1 70
Operators trained on procedure
10036007 rev G

Calibrate Inspiratory Calibrate Inspiratory Procedure: PB560, Procedures misinterpreted Inspiratory Flow sensor not N/A Lack of review of Procedure is ECO controlled in Agile; ALARP - Review PFMEA as part of G- PB560 Reviewed historical failure
Flow Sensor Flow Sensor Calibration and Test - P/N due lack of clarity; calibrated correctly procedure Process is validated - LR0005; Flow rates QAP056. Review procedure vs practice. Check Manufacturing yield data and PFMEA for
10036007 incorrectly written are verified in this test section customer complaint rates. Revise occurance Engineer. PB540. Based on this
7 10 2 140 rating accordingly. data, reduce occurrence 7 2 2 28
rate in line with PB540

Operator Operator: does not follow Inspiratory Flow sensor not N/A Operator doesn't follow Operator trained and signed off on ALARP - Review PFMEA as part of G- PB560 Reviewed historical failure
test procedure calibrated correctly procedure - calibration procedure per G-QAP017 . Flow rates QAP056. Review procedure vs practice. Check Manufacturing yield data and PFMEA for
not accurate or record are checked after calibration in this customer complaint rates. Revise occurance Engineer. PB540. Based on this
7 wrong flow reading, 10 section., and volume tests are done in 2 140 rating accordingly. data, reduce occurrence 7 4 2 56
typos Final Test. Measurements checked rate in line with PB540
against limits in Product Authorisation
Release.

Test Equipment: 22mm air Test Equipment: Air tubing Inspiratory Flow sensor not N/A Broken or cracked air Preventive Maintenance Procedure G- N/A N/A N/A
tubing leaking air calibrated correctly- hose AMFG-1180-00 inspects air tubing.
measurements are not 7 3 Process is validated - LR0005; 3 63 - - - -
accurate
Turbine Performance Turbine Performance Procedure: PB560, Procedures misinterpreted Turbine performance is not N/A Lack of review of Procedure is ECO controlled in Agile; ALARP - Review PFMEA as part of G- PB560 Reviewed historical failure
Tests Tests Calibration and Test - P/N due lack of clarity; checked properly procedure Process is validated - LR0004; QAP056. Review procedure vs practice. Check Manufacturing yield data and PFMEA for
10036007 incorrectly written customer complaint rates. Revise occurance Engineer. PB540. Based on this
7 10 2 140 rating accordingly. data, reduce occurrence 7 2 2 28
rate in line with PB540

Operator: Operator: does not follow Turbine performance is not N/A Operator doesn't follow Operator trained and signed off on ALARP - Review PFMEA as part of G- PB560 Reviewed historical failure
test procedure correctly checked properly - potential procedure - setup, mis- procedure per G-QAP017. QAP056. Review procedure vs practice. Check Manufacturing yield data and PFMEA for
for missed faults or false reading PTS2000, Measurements checked against limits in customer complaint rates. Revise occurance Engineer. PB540. Based on this
failures or inaccurate recording incorrect Product Authorisation Release. Turbine rating accordingly. data, reduce occurrence
measurements value. PTS2000 is failures would be caught in Final System rate in line with PB540
7 powered on with 10 Test in the Volume accuracy section 2 140 7 5 2 70
pressure applied to (1500mL). Procedure contains warning to
input not apply pressure during power-up.
PTS2000 is not power cycled during any
tesing.

Test Equipment: Patient Test Equipment: Air tubing Turbine performance is not N/A Broken or cracked air Preventive Maintenance Procedure G- N/A N/A N/A
Connector Assembly #2 leaking air checked properly- hose AMFG-1180-00 inspects air tubing/fitting.
measurements are not 7 4 Process is validated - LR0005; 2 56 - - - -
accurate
Test Equipment: Test Equipment: PTS2000 Turbine performance is not N/A PTS2000 is out of Process is validated - LR0005; N/A N/A N/A
PTS2000 is not reading accurately checked properly- calibration Equipment is on a 3 month internal
measurements are not 7 3 calibration schedule and 12 month ext 3 63 - - - -
accurate calibration .

Page 13 of 21 10037310U00
 Process FMEA for PB560

S
e
v R
O D S O D R
e P
CTQ CTS Process Function Process Step Key Process Input Potential Failure Mode Potential Failure Effects Hazard Tag r Potential Causes C Current Controls E Actions Recommended Resp. Actions Taken E C E P
N
i C T V C T N
t
y

How often does cause or

FM occur?

cause or FM?
Critical to Critical to Safety: Operation Name for Description of step What is the Key Process In what ways does the Key What is the impact on the Key Unique Identifier for the How What causes the Key What are the existing controls and What are the actions for reducing the Whose What are the completed

How well can you detect

Quality Risk documents listed Manufacturing task within operation Input? Input go wrong? Output Variables (Customer hazard severity Input to go wrong? procedures (inspection and test) that occurrence of the Cause, or improving Responsible for actions taken with the
in this column must Requirements) or internal effects prevent either the cause or the Failure detection? Should have actions only on the recalculated RPN? Be
be reviewed prior to requirements? the Mode? Should include an SOP high RPN's or easy fixes. recommended sure to include
making any changes process number. action? completion month/year
to procedures in Key
Process Input or
Current Controls

Battery Discharge- Battery Discharge- Procedure: PB560, Procedures misinterpreted Battery discharge-charge N/A Lack of review of Procedure is ECO controlled in Agile; ALARP - Review PFMEA as part of G- PB560 Reviewed historical failure
Charge Cycle Charge Cycle Calibration and Test - P/N due lack of clarity; cycle not run correctly with procedure Process is validated - LR0005; QAP056. Review procedure vs practice. Check Manufacturing yield data and PFMEA for
10036007 incorrectly written missing low battery/empty customer complaint rates. Revise occurance Engineer. PB540. Based on this
battery alarms or battery not 5 10 2 100 rating accordingly. data, reduce occurrence 5 2 2 20
fully charging rate in line with PB540

Operator: Operator: does not follow Battery discharge-charge N/A Operator doesn't follow Low and Empty Battery Alarm Event ALARP - Review PFMEA as part of G- PB560 Reviewed historical failure
test procedure cycle not run correctly with procedure - inccorrect times are recorded on DHR and checked QAP056. Review procedure vs practice. Check Manufacturing yield data and PFMEA for
missing low battery/empty vent settings set, or not by Product release Authorisation. customer complaint rates. Revise occurance Engineer. PB540. Based on this
battery alarms or battery not verifying log time Operator trained and signed off on rating accordingly. data, reduce occurrence
fully charging 5 between low and empty 10 procedure per G-QAP017. Alarm time 3 150 rate in line with PB540 5 5 3 75
battery alarms correctly and % charged are recorded and
checked by Product release Authorisation
Authorisation

Test Equipment: AC Test Equipment: incorrect Battery discharge-charge N/A Inproperly set or faulty Timer cover prevents tampering. N/A N/A N/A
Timer discharge or charge times cycle not run correctly with AC timer 10036007 procedure includes Daily
missing low battery/empty 5 3 Check for timer setting check. Process is 4 60 - - - -
battery alarms or battery not validated - LR0005;
fully charging
Test Equipment: Patient Test Equipment: Air tubing Unexpected alarms due to air N/A Broken or cracked air Preventive Maintenance Procedure G- N/A N/A N/A
Connector Assembly #1 leaking air leaks 5 hose 3 AMFG-1180-00 inspects tubing/fitting. 4 60 - - - -
Process is validated - LR0005;
System System Operator Operator: reads/records the Test not executed correctly - N/A Operator doesn't follow Operator trained and signed off on N/A N/A N/A
Measurements Check Measurements Check wrong value or does not potential for missed faults or procedure - reads procedure per G-QAP017.
make measurements false failures measurement Measurements are checked against limits
immediately after the 6 incorrectly or typo 4 in Product Authorisation Release 3 72 - - - -
overnight battery errors in recording
discharge/charge cycle
Procedure: PB560, Procedures misinterpreted Incorrect limits specified N/A Lack of review of Procedure is ECO controlled in Agile; N/A N/A N/A
Calibration and Test - P/N due lack of clarity; 6 procedure 2 Process is validated - LR0005; 2 24 - - - -
10036007 incorrectly written
CTQ Check Battery Check Battery Operator Operator: reads/records the Battery information is not N/A Operator doesn't follow Operator trained and signed off on ALARP - Review PFMEA as part of G- PB560 Reviewed historical failure
wrong value or does not checked correctly procedure - operator procedure. Measurements recorded on QAP056. Review procedure vs practice. Check Manufacturing yield data and PFMEA for
make measurements mis-reads or records DHR and checked by Product release customer complaint rates. Revise occurance Engineer. PB540. Based on this
immediately after the 7 bad data as good data 10 Authorisation Authorisation 2 140 rating accordingly. data, reduce occurrence 7 4 2 56
overnight battery rate in line with PB540
discharge/charge cycle
Procedure: PB560, Procedures misinterpreted Battery information is not N/A Lack of review of Procedure is ECO controlled in Agile; ALARP - Review PFMEA as part of G- PB560 Reviewed historical failure
Calibration and Test - P/N due lack of clarity; checked properly-incorrect procedure Process is validated - LR0005; QAP056. Review procedure vs practice. Check Manufacturing yield data and PFMEA for
10036007 incorrectly written limits used customer complaint rates. Revise occurance Engineer. PB540. Based on this
7 10 2 140 rating accordingly. data, reduce occurrence 7 2 2 28
rate in line with PB540

CTQ Alarm (buzzer) sound Alarm (buzzer) sound Procedure: PB560, Procedures misinterpreted Alarm sound level test is not N/A Lack of review of Procedure is ECO controlled in Agile; N/A N/A N/A
level tests level tests Calibration and Test - P/N due lack of clarity; executed correctly 8 procedure 10 Process is validated - LR0005; 1 80 - - - -
10036007 incorrectly written
Operator Operator: does not follow Alarm sound level test not N/A Operator doesn't follow Operator trained and signed off on N/A N/A N/A
test procedure executed to test procedure procedure - operator procedure which clearly states where to
correctly - potential for missed misreads a bad Sound position the sound level meter. Sound
faults or false failures Level Meter level has easy to read digital display
measurement as good,
or has the sound level
8 meter in the wrong 10 1 80 - - - -
position - false failure,
or does not have the
sound level meter
Range set per
procedure

Test Equipment: Sound The Alarm sound level is Alarm sound level - potential N/A Sound level meter is Process is validated - LR0005; N/A N/A N/A
Level Meter reading incorrectly for missed faults or false out of calibration Equipment is on a calibration schedule.
failues 8 1 Sound Level Meter is checked on a daily 2 16 - - - -
basis and recorded on log 10039028

Faults Log Check Faults Log Check Procedure: PB560, Procedures misinterpreted Faults Log is not checked N/A Lack of review of Procedure is ECO controlled in Agile; ALARP - Review PFMEA as part of G- PB560 Reviewed historical failure
Calibration and Test - P/N due lack of clarity; properly - list of applicable procedure Process is validated - LR0005; QAP056. Review procedure vs practice. Check Manufacturing yield data and PFMEA for
10036007 incorrectly written faults is not complete customer complaint rates. Revise occurance Engineer. PB540. Based on this
5 10 2 100 rating accordingly. data, reduce occurrence 5 2 2 20
rate in line with PB540

Operator Operator: does not follow Important fault is missed so N/A Operator doesn't follow Operator trained and signed off on ALARP - Review PFMEA as part of G- PB560 Reviewed historical failure
test procedure correctly vent is failed for normal procedure - operator procedure per G-QAP017. Fault log is QAP056. Review procedure vs practice. Check Manufacturing yield data and PFMEA for
operating fault reads/records checked again in Final System test customer complaint rates. Revise occurance Engineer. PB540. Based on this
5 information incorrectly 10 procedure 10039030 3 150 rating accordingly. data, reduce occurrence 5 5 3 150
or missses importamt rate in line with PB540
log events

Battery Discharge- Battery Discharge- Procedure: PB560, Procedures misinterpreted Alarm Event times are not N/A Lack of review of Procedure is ECO controlled in Agile; ALARP - Review PFMEA as part of G- PB560 Reviewed historical failure
Charge Cycle Event Charge Cycle Event Calibration and Test - P/N due lack of clarity; recorded and/or evaluated procedure Process is validated - LR0005; QAP056. Review procedure vs practice. Check Manufacturing yield data and PFMEA for
Times Times 10036007 incorrectly written properly customer complaint rates. Revise occurance Engineer. PB540. Based on this
8 10 2 160 rating accordingly. data, reduce occurrence 8 2 2 32
rate in line with PB540

Page 14 of 21 10037310U00
 Process FMEA for PB560

S
e
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O D S O D R
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CTQ CTS Process Function Process Step Key Process Input Potential Failure Mode Potential Failure Effects Hazard Tag r Potential Causes C Current Controls E Actions Recommended Resp. Actions Taken E C E P
N
i C T V C T N
t
y

How often does cause or

FM occur?

cause or FM?
Critical to Critical to Safety: Operation Name for Description of step What is the Key Process In what ways does the Key What is the impact on the Key Unique Identifier for the How What causes the Key What are the existing controls and What are the actions for reducing the Whose What are the completed

How well can you detect

Quality Risk documents listed Manufacturing task within operation Input? Input go wrong? Output Variables (Customer hazard severity Input to go wrong? procedures (inspection and test) that occurrence of the Cause, or improving Responsible for actions taken with the
in this column must Requirements) or internal effects prevent either the cause or the Failure detection? Should have actions only on the recalculated RPN? Be
be reviewed prior to requirements? the Mode? Should include an SOP high RPN's or easy fixes. recommended sure to include
making any changes process number. action? completion month/year
to procedures in Key
Process Input or
Current Controls

Operator Operator: does not follow Alarm Event times are not N/A Operator does not Operator trained and signed off on ALARP - Review PFMEA as part of G- PB560 Reviewed historical failure
test procedure; math error recorded and/or evaluated record the corrrect procedure per G-QAP017. Fault log is QAP056. Review procedure vs practice. Check Manufacturing yield data and PFMEA for
properly (math mistake) event time or makes a checked again in Final System test. customer complaint rates. Revise occurance Engineer. PB540. Based on this
math mistake Measurements recorded on DHR and rating accordingly. data, reduce occurrence
8 calculating the low to 10 checked by Product release Authorisation 2 160 rate in line with PB540 8 5 2 80
involuntay stop or Authorisation
empty to involuntary
stop alarm events

PB PVTS Downlaod s/w Download Software is not Alarm Event times may not be N/A specific to reason for Process is validated - LR0005. PB PVTS N/A N/A N/A
Tool p/n 100322788 the correct version accurately displayed for update software is validated and ECO
printout 8 2 controlled/realeased, A validation 3 48 - - - -
process is performed with update of
PVTS software.
Vent Preliminary Vent Preliminary Procedure: PB560, Procedures misinterpreted Paperwork or vent exterior N/A Lack of review of Procedure is ECO controlled in Agile; N/A N/A N/A
Checks Checks System Final Test - P/N due lack of clarity; checks are performed 4 procedure 10 Process is validated - LR0005; 2 80 - - - -
10039030 incorrectly written correctly
Operator Operator: does not follow Paperwork or vent exterior N/A Operator doesn't follow Operator trained and signed off on N/A N/A N/A
test procedure correctly checks are not performed procedure - checks not procedure per G-QAP017. S/n checked
correctly made thoroughly at Pack process, Calibration/DHR
4 10 checked by Product release 2 80 - - - -
Authorisation, Screw check in this step is
an addional check to assembly
Real Time Clock Real Time Clock Procedure: PB560, Procedures misinterpreted Time and Date are not verified N/A Lack of review of Procedure is ECO controlled in Agile; ALARP - Review PFMEA as part of G- PB560 Reviewed historical failure
Tests Tests System Final Test - P/N due lack of clarity; accurately procedure Process is validated - LR0005; QAP056. Review procedure vs practice. Check Manufacturing yield data and PFMEA for
10039030 incorrectly written customer complaint rates. Revise occurance Engineer. PB540. Based on this
3 10 4 120 rating accordingly. data, reduce occurrence 3 2 4 24
rate in line with PB540

Operator: Operator: does not follow Time and Date are not verified N/A Operator doesn't follow Operator trained and signed off on ALARP - Review PFMEA as part of G- PB560 Reviewed historical failure
test procedure correctly accurately procedure in procedure. Simple process to read QAP056. Review procedure vs practice. Check Manufacturing yield data and PFMEA for
misreading time or date date/time customer complaint rates. Revise occurance Engineer. PB540. Based on this
3 10 4 120 rating accordingly. data, reduce occurrence 3 4 4 48
rate in line with PB540

CTQ O2 Valve Leak Tests O2 Valve Leak Tests Procedure: PB560, Procedures misinterpreted O2 Valve Leak test is not N/A Lack of review of Procedure is ECO controlled in Agile; ALARP - Review PFMEA as part of G- PB560 Reviewed historical failure
System Final Test - P/N due lack of clarity; executed correctly procedure Process is validated - LR0005; QAP056. Review procedure vs practice. Check Manufacturing yield data and PFMEA for
10039030 incorrectly written customer complaint rates. Revise occurance Engineer. PB540. Based on this
7 10 2 140 rating accordingly. data, reduce occurrence 7 2 2 28
rate in line with PB540

Operator Operator: does not follow O2 Valve Leak test is not N/A Operator doesn't follow Operator trained and signed off on ALARP - Review PFMEA as part of G- PB560 Reviewed historical failure
test procedure correctly executed correctly procedure - setup procedure. Test is automated. QAP056. Review procedure vs practice. Check Manufacturing yield data and PFMEA for
customer complaint rates. Revise occurance Engineer. PB540. Based on this
7 10 2 140 rating accordingly. data, reduce occurrence 7 4 2 56
rate in line with PB540

Test Equipment: Leak Test Equipment: Leak O2 Valve Leak test is not N/A Leak Tester has the Process is validated - LR0005; N/A N/A N/A
Tester Tester does not function as executed correctly incorrect settings, tester Equipment is on a calibration schedule.
expected fault or calibration error Settings are stored in the tester unit.
7 2 10023391 O2 Valve Leak Test doc 4 56 - - - -
describes setup. Spare Leak Tester
available
Test Equipment: Leak Test Equipment: Leak O2 Valve Leak test is not N/A Test Equipment: Leak Process is validated - LR0005; leak in N/A N/A N/A
Tester output air Tester output air executed correctly - false Tester output air output tubing/fitting will fail 'Fill' poortion
tubing/couplings tubing/couplings leaks air failures tubing/couplings is of automated test routine. Slower rate
4 damaged 2 leaks will fail test repeatdly. Preventive 3 24 - - - -
Maintenance Procedure G-AMFG-1180-
00 inspects air tubing/couplings
Air Supply Air Supply: Pressure not O2 Valve Leak test is not N/A Air Supply: Pressure Process is validated - LR0005; Air N/A N/A N/A
correct executed correctly if air not between 110- pressure is sourced from a regulated
pressure is low or leak tester 140psi supply. Daily check verifies air supply
may be damaged is air 7 4 pressure and recorded on log p/n 2 56 - - - -
pressure is too high 10039034. Valve Leak Test doc p/n
100233912 describes setup.
CTQ Volume and Pressure Volume and Pressure Procedure: PB560, Procedures misinterpreted Expiratory Flow sensor not N/A Lack of review of Procedure is ECO controlled in Agile; ALARP - Review PFMEA as part of G- PB560 Reviewed historical failure
Tests: Calibrate Tests: Calibrate Calibration and Test - P/N due lack of clarity; calibrated correctly procedure Process is validated - LR0005; Flow rates QAP056. Review procedure vs practice. Check Manufacturing yield data and PFMEA for
Expiratory Flow Expiratory Flow 10036007 incorrectly written are checked in the section customer complaint rates. Revise occurance Engineer. PB540. Based on this
Sensor Sensor 7 10 2 140 rating accordingly. data, reduce occurrence 7 4 2 56
rate in line with PB540

Operator Operator: does not follow Expiratory Flow sensor not N/A Operator doesn't follow Operator trained and signed off on ALARP - Review PFMEA as part of G- PB560 Reviewed practice vs.
test procedure calibrated correctly procedure - missing a procedure per G-QAP017 . Simple QAP056. Review procedure vs practice. Check Manufacturing procedure during
7 CAL FAULT message 10 process with little possibility for operator 2 140 customer complaint rates. Revise occurance Engineer. validation build. No 7 4 2 56
on vent mistakes. Expiratory volume rating accordingly. occurrence detected
measurement checks calibration during the build.
Operator Operator: does not select Expiratory Flow sensor not N/A Operator does not Operator trained and signed off on ALARP - Review PFMEA as part of G- PB560 Reviewed practice vs.
Pediatric Patient Circuit to calibrated correctly for follow procedure - procedure per G-QAP017 . Check box QAP056. Review procedure vs practice. Check Manufacturing procedure during
Yes option in the vent Pediatric, pediatric ingores step added in DHR 10038461 for selecting the customer complaint rates. Revise occurance Engineer. validation build. No
preferences menu for volume/pressure tests may fail 7 10 Pediatric Patient Circuit option in the vent 2 140 rating accordingly. occurrence detected 7 4 2 56
calibrating and testing using preferences menu during the build.
the Pediatric patient circuit

Page 15 of 21 10037310U00
 Process FMEA for PB560

S
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CTQ CTS Process Function Process Step Key Process Input Potential Failure Mode Potential Failure Effects Hazard Tag r Potential Causes C Current Controls E Actions Recommended Resp. Actions Taken E C E P
N
i C T V C T N
t
y

How often does cause or

FM occur?

cause or FM?
Critical to Critical to Safety: Operation Name for Description of step What is the Key Process In what ways does the Key What is the impact on the Key Unique Identifier for the How What causes the Key What are the existing controls and What are the actions for reducing the Whose What are the completed

How well can you detect

Quality Risk documents listed Manufacturing task within operation Input? Input go wrong? Output Variables (Customer hazard severity Input to go wrong? procedures (inspection and test) that occurrence of the Cause, or improving Responsible for actions taken with the
in this column must Requirements) or internal effects prevent either the cause or the Failure detection? Should have actions only on the recalculated RPN? Be
be reviewed prior to requirements? the Mode? Should include an SOP high RPN's or easy fixes. recommended sure to include
making any changes process number. action? completion month/year
to procedures in Key
Process Input or
Current Controls

Operator Operator: does not select Expiratory Flow sensor not N/A Operator does not Operator trained and signed off on ALARP - Review PFMEA as part of G- PB560 Reviewed practice vs.
Pediatric Patient Circuit to calibrated correctly for Adult, follow procedure - procedure per G-QAP017 . Check box QAP056. Review procedure vs practice. Check Manufacturing procedure during
No in the vent preferences adult volume/pressure tests 7 ingores step 10 added in DHR 10038461 for de-selecting 2 140 customer complaint rates. Revise occurance Engineer. validation build. No 7 4 2 56
menu after Pediatric testing may fail the Pediatric Patient Circuit option in the rating accordingly. occurrence detected
vent preferences menu during the build.
Test Equipment: Patient Test Equipment: Air tubing Expiratory Flow sensor not N/A Broken or cracked air Test procedure 10039030 has a daily N/A N/A N/A
Circuit leaking air calibrated correctly- hose inspection of tubing. Process is validated
measurements are not 7 4 - LR0005 2 56 - - - -
accurate
CTQ Volume and Pressure Volume and Pressure Procedure: PB560, Procedures misinterpreted Volume or Pressure Test is N/A Lack of review of Procedure is ECO controlled in Agile; ALARP - Review PFMEA as part of G- PB560 Reviewed historical failure
Tests Tests System Final Test - P/N due lack of clarity; not executed correctly procedure Process is validated - LR0004/LR0005; QAP056. Review procedure vs practice. Check Manufacturing yield data and PFMEA for
10039030 incorrectly written customer complaint rates. Revise occurance Engineer. PB540. Based on this
8 10 2 160 rating accordingly. data, reduce occurrence 8 3 2 48
rate in line with PB540

Open Vent Test Software Incorrect version of Open Volume or Pressure Test is N/A Lack of SW version Software is ECO controlled in Agile; N/A N/A N/A
Tool p/n 10026042 Vent S/W used not executed correctly 8 control 3 Process is validated - LR0004/LR0005; 3 72 - - - -

Open Vent Test Software s/w tool causes test a blank Volume or Pressure Test is N/A Lack of s/w tool testing Software has error handling code so that N/A N/A N/A
Tool p/n 10026042 test report sheet to be not executed completely 5 5 if there are any com errors, a test report 2 50 - - - -
produced will not be produced
Test Software: Incorrect version of Test Volume or Pressure Test is N/A Lack of document Scripts are ECO controlled in Agile; N/A N/A N/A
Ped Test Script P/N Script used not executed correctly (script) version control Process is validated - LR0004/LR0005;
10039032 8 3 3 72 - - - -
Adult Test Script
P/N 10039033
Test Software: Test Script has test Volume and/or Pressure Test N/A Lack of review of test Test Script is peer reviewed and N/A N/A N/A
Ped Test Script P/N command written wrong is not executed correctly script controlled in Agile; Process is validated -
10039032 8 2 LR0004/LR0005; 3 48 - - - -
Adult Test Script
P/N 10039033
Operator: Pediatric and Adult Tests: Pressure test is not executed N/A Operator doesn't follow Operator trained and signed off on N/A N/A N/A
Proximal Pressure tubing correctly - false failures will be procedure to connect procedure per G-QAP017. Vent will
from vent to PTS2000 low reported for pressure tests in pressure tubing to display 'Check Prox Line' error and test
pressure input is not both Ped and Adult scripts. 2 PTS2000 10 report will fail pressure tests. Pediatric 2 40 - - - -
connected for test test script will additionally fail the Safety
Pressure Test.
Operator: Pediatric Tests: The Adult Volume and Pressure tests N/A Operator doesn't follow Operator trained and signed off on N/A N/A N/A
test lung is connected are not executed correctly - procedure to connect procedure per G-QAP017. Vent will
instead of the Pediatric Test false failures will be reported Adult test lung display 'Low Pressure Disconnect ' alarm
lung for volume and pressure tests 2 10 and test report will indicate a 2 40 - - - -
Disconnection Alarm and Safety Pressure
failures
Operator: Pediatric Tests: The Adult Volume and Pressure tests N/A Operator doesn't follow Operator trained and signed off on N/A N/A N/A
test script is executed are not executed correctly - procedure to execute procedure per G-QAP017. The Vent will
instead of the Pediatric Test false failures will be reported 2 pediatric test script as 10 indicate a 'High Pressure ' alarm and the 2 40 - - - -
script for volume and pressure tests directed test report will indicate a 'High Pressure'
failure
Operator: Pediatric and Adult Tests: Volume and Pressure tests N/A Operator doesn't follow Operator trained and signed off on N/A N/A N/A
The exhl valve control are not executed correctly - procedure to connect procedure per G-QAP017. The Vent will
pressure line is not false failures will be reported 2 the exhl valve as 10 indicate a 'Check Exhl Valve' alarm. 2 40 - - - -
connected to vent insp for volume and pressure tests directed
block
Operator: Pediatric and Adult Tests: Volume and Pressure tests N/A Operator doesn't follow Operator trained and signed off on N/A N/A N/A
The test lung is not are not executed correctly - procedure to connect procedure per G-QAP017. The Vent will
connected false failures will be reported 2 the appropiate test lung 10 indicate a 'Low Pressure ' alarm and the 2 40 - - - -
for volume and pressure tests as directed test report will indicate a 'Disconnection
Alarm' failure
Operator: Adult Tests: The pediatric Volume and Pressure tests N/A Operator doesn't follow Operator trained and signed off on N/A N/A N/A
test lung is connected are not executed correctly - procedure to connect procedure per G-QAP017. The Vent will
instead of the adult test false failures will be reported 2 the adult test lung as 10 indicate a 'High Pressure ' alarm and the 2 40 - - - -
lung connected for volume and pressure tests directed test report will indicate a 'High Pressure'
failure in volume tests
Operator: Adult Tests: The pediatric Volume and Pressure tests N/A Operator doesn't follow Operator trained and signed off on N/A N/A N/A
test script is executed are not executed correctly - procedure to execute procedure per G-QAP017. The Vent will
instead of the adult test false failures will be reported 2 the adult test script as 10 indicate a 'Low Pressure ' alarm and the 2 40 - - - -
script for volume and pressure tests directed test report will indicate a 'Disconnection
Alarm' failure
Operator: A Fail Test result on the test False Pass N/A Operator misses a Fail Operator trained and signed off on ALARP - Review PFMEA as part of G- PB560 Reviewed historical failure
report is missed when Result procedure per G-QAP017. QAP056. Review procedure vs practice. Check Manufacturing yield data and PFMEA for
assessing the overall test Measurements recorded on DHR and customer complaint rates. Revise occurance Engineer. PB540. Based on this
result 8 10 checked by Product release 2 160 rating accordingly. data, reduce occurrence 8 2 2 32
Authorisation. rate in line with PB540

Test Equipment: Test Equipment: PTS2000 Pressure Control Test is not N/A PTS2000 Null Pressure Pediatric and Adult Test Scripts performs N/A N/A N/A
PTS2000 does not measure pressure executed correctly - Pressure is not at zero a zero PTS200 pressure command at the
accurately Mode of vent is not checked to 8 3 beginning of each test script. 2 48 - - - -
test procedure
Test Equipment: Test Equipment: PTS2000 Volume and Pressure tests N/A PTS2000 is out of Process is validated - LR0004/LR0005; N/A N/A N/A
PTS2000 does not measure pressure are not executed correctly - calibration or Equipment is on a 3 month internal
or volume accurately false failures will be reported 8 equipment fault. 1 calibration schedule and 12 month ext 3 24 - - - -
for volume and pressure tests calibration .

Page 16 of 21 10037310U00
 Process FMEA for PB560

S
e
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O D S O D R
e P
CTQ CTS Process Function Process Step Key Process Input Potential Failure Mode Potential Failure Effects Hazard Tag r Potential Causes C Current Controls E Actions Recommended Resp. Actions Taken E C E P
N
i C T V C T N
t
y

How often does cause or

FM occur?

cause or FM?
Critical to Critical to Safety: Operation Name for Description of step What is the Key Process In what ways does the Key What is the impact on the Key Unique Identifier for the How What causes the Key What are the existing controls and What are the actions for reducing the Whose What are the completed

How well can you detect

Quality Risk documents listed Manufacturing task within operation Input? Input go wrong? Output Variables (Customer hazard severity Input to go wrong? procedures (inspection and test) that occurrence of the Cause, or improving Responsible for actions taken with the
in this column must Requirements) or internal effects prevent either the cause or the Failure detection? Should have actions only on the recalculated RPN? Be
be reviewed prior to requirements? the Mode? Should include an SOP high RPN's or easy fixes. recommended sure to include
making any changes process number. action? completion month/year
to procedures in Key
Process Input or
Current Controls

Test Equipment: Patient Test Equipment: Patient Pressure or Volume Test is N/A Test Equipment: Process is validated - LR0004/LR0005; N/A N/A N/A
Circuit and air Circuit and air not executed correctly - false Patient Circuit and air Patient tubing and exhl valve is on a 2
tubing/couplings tubing/couplings leaks air failures or false pass 9 tubing/couplings is 2 week replacement schedule. Preventive 3 54 - - - -
damaged Maintenance Procedure G-AMFG-1180-
00 inspects air tubing/fittings.
FiO2 Sensor FiO2 Sensor Procedure: PB560, Procedures misinterpreted FiO2 Sensor Detection Test N/A Lack of review of Procedure is ECO controlled in Agile; ALARP - Review PFMEA as part of G- PB560 Reviewed procedure vs
Detection Test Detection Test System Final Test - P/N due lack of clarity; function is not checked procedure Process is validated - LR0005; QAP056. Review procedure vs practice. Check Manufacturing practice during validation
10039030 incorrectly written correctly 8 10 2 160 customer complaint rates. Revise occurance Engineer. build. No occurence 8 4 2 48
rating accordingly. detected during build.
Operator FiO2 Sensor Detection Test N/A Operator doesn't follow Operator trained and signed off on ALARP - Review PFMEA as part of G- PB560 Reviewed procedure vs
function is not checked procedure - FiO2 procedure per G-QAP017 QAP056. Review procedure vs practice. Check Manufacturing practice during validation
correctly 8 sensor/cable setup . 10 2 160 customer complaint rates. Revise occurance Engineer. build. No occurence 8 4 2 48
FiO2 Sensor Detection is
incorrectly passed. rating accordingly. detected during build.
Operator FiO2 Sensor 'use by' date is N/A FiO2 Sensor is faulty or Spare (Airox) FiO2 Sensor is available. ALARP - Review PFMEA as part of G- PB560 FI02 Sensor is added to
not checked. past service life FiO2 Sensor is marked with end of use QAP056. Review procedure vs practice. Check Manufacturing the shelf life procedure G-
label. Length of test use is reduced from customer complaint rates. Revise occurance Engineer. AMFG-1066-00.
recommended Service Life term rating accordingly. Reviewed practice vs.
8 10 2 160 procedure during 8 4 2 48
validation build. No
occurrence detected
FiO2 Sensor Detection is during build.
incorrectly passed.
O2 Valve Funtional O2 Valve Funtional Procedure: PB560, Procedures misinterpreted O2 Valve Functional test is not N/A Lack of review of Procedure is ECO controlled in Agile; ALARP - Review PFMEA as part of G- PB560 Reviewed historical failure
Tests Tests System Final Test - P/N due lack of clarity; executed correctly procedure Process is validated - LR0004; QAP056. Review procedure vs practice. Check Manufacturing yield data and PFMEA for
10039030 incorrectly written customer complaint rates. Revise occurance Engineer. PB540. Based on this
8 10 2 160 rating accordingly. data, reduce occurrence 8 2 2 32
rate in line with PB540

Operator Operator: does not follow O2 Valve Functional test is not N/A Operator doesn't follow Operator trained and signed off on ALARP - Review PFMEA as part of G- PB560 Reviewed historical failure
test procedure correctly executed correctly according procedure - setup, procedure per G-QAP017. QAP056. Review procedure vs practice. Check Manufacturing yield data and PFMEA for
to test procedure. misreads a bad Measurements recorded on DHR and customer complaint rates. Revise occurance Engineer. PB540. Based on this
8 PTS2000 value as 10 checked by Product release 2 160 rating accordingly. data, reduce occurrence 8 3 2 48
good or records wrong Authorisation. rate in line with PB540
values.
Test Equipment: Test Equipment: PTS2000 Pressure Control Test is not N/A PTS2000 is out of Process is validated - LR0005; N/A N/A N/A
PTS2000 does not measure % O2 executed correctly - O2 valve calibration or Equipment is on a 3 month internal
accurately is not checked to test 8 equipment fault 1 calibration schedule and 12 month ext 3 24 - - - -
procedure calibration .
Test Equipment: O2 Test Equipment: O2 O2 Valve Functional test is not N/A O2 tubing/couplings is Process is validated - LR0005; O2 leak N/A N/A N/A
tubing/couplings tubing/couplings leaks O2 executed correctly - false damaged would cause a false failure. Preventive
gas failures 5 4 Maintenance Procedure G-AMFG-1180- 3 60 - - - -
00 inspects air tubing/fitting
O2 Supply O2 Supply: Pressure not O2 Valve Functional test is not N/A O2 supply is turned off Process is validated - LR0005; O2 N/A N/A N/A
correct executed correctly if O2 or pressure is set to low pressure is sourced from a regulated
pressure is low 8 4 supply. Daily check verifies O2 supply 2 64 - - - -
setting and reocrded on log 10039304
Operator Fail to cross out additional Serial number on test report is N/A Operator doesn't follow Operator trained and signed off on N/A N/A N/A
00 at the end of test report miss read. 1 procedure 10 procedure per G-QAP017. Test report is 2 20 - - - -
printout. reviewed at test and pack.
Default Shipping Default Shipping Procedure: PB560, Procedures misinterpreted Incorrect Shipping Parameters N/A Lack of review of Procedure is ECO controlled in Agile; N/A N/A N/A
Paramters Set Paramters Set System Final Test - P/N due lack of clarity; specified - customer recieves procedure Process is validated - LR0005; operator
10039030 incorrectly written vent with incorrect paramters 2 10 trained and signed off on procedure 2 40 - - - -
initially set

Operator Operator: does not follow Incorrect Shipping Parameters N/A Operator doesn't follow Operator trained and signed off on N/A N/A N/A
test procedure set - customer recieves vent procedure - wrong vent procedure per G-QAP017
with incorrect paramters 2 paramters set 10 4 80 - - - -
initially set
Clear Vent Logs/ Clear Vent Logs/ Procedure: PB560, Procedures misinterpreted Faults Log is not cleared or N/A Lack of review of Procedure is ECO controlled in Agile; N/A N/A N/A
Faults Log Check Faults Log Check System Final Test - P/N due lack of clarity; checked properly - list of procedure Process is validated - LR0005;
10039030 incorrectly written applicable faults is not 2 10 2 40 - - - -
complete
Operator Operator: does not follow Important fault is missed or N/A Operator doesn't follow Operator trained and signed off on N/A N/A N/A
test procedure correctly vent is failed for normal procedure - fault log not procedure per G-QAP017
operating fault 2 cleared or important 10 4 80 - - - -
fault missed
Pack 10039897 Pack 10039897 Misinterpreted due to lack Misinterpreted due to lack of N/A QS00002016 formally ECO released via
UDI Barcode Grading of clarity; incorrectly written, clarity; incorrectly written, or Procedure not reviewed AGILE. Operators trained & signed off on
8 4 2 64 N/A N/A N/A N/A N/A N/A N/A
Verifier / equipment or operator does not follow operator does not follow / operator error procedure. Training matrix on line G-
procedure procedure AMFG-1037-130
Hardware faulty, Verifier will Hardware faulty, Verifier will N/A Equipment Validated per G-QAP012.
UDI Barcode Grading Verifier equipment
not perform grading of not perform grading of 8 2 Equipment Calibrated to schedule per QA 2 32 N/A N/A N/A N/A N/A N/A N/A
Verifier / equipment malfunction
Barcode Barcode G-QAP019
Manual Operation Label not applied, loss of Label not applied, loss of N/A Checked at pack. Labelview allows 1
7 Operator Error 3 2 42 N/A N/A N/A N/A N/A N/A N/A
tracibility tracibility print of each serial number only
Pack 10039897 Pack 10039897 Process task Incorrect s/n printed on FOOB N/A Printing error Training; 10039897. Check in pack N/A N/A N/A
4 10 1 40 N/A N/A N/A N/A
outer carton label procedure
Pack 10039897 Pack 10039897 Process task Incorrect s/n shipped Lack of field traceability / issue N/A Operator does not Training; 10039897. Check in pack N/A N/A N/A
4 10 1 40 N/A N/A N/A N/A
at Distribution site. follow procedure. procedure
Misinterpreted due to lack N/A QS00002016 formally ECO released via
UDI Barcode Grading of clarity; incorrectly written, Verifier does not grade Ship Procedure not reviewed AGILE. Operators trained & signed off on
8 4 2 64 N/A N/A N/A N/A N/A N/A N/A
Verifier / equipment or operator does not follow Carton Label Barcode(s) / operator error procedure. Training matrix on line G-
procedure AMFG-1037-130
Hardware faulty, Verifier will N/A Equipment Validated per G-QAP012.
UDI Barcode Grading Operator unable to carry out Verifier equipment
not perform grading of 8 2 Equipment Calibrated to schedule per QA 2 32 N/A N/A N/A N/A N/A N/A N/A
Verifier / equipment step malfunction
Barcode G-QAP019

Page 17 of 21 10037310U00
 Process FMEA for PB560

S
e
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CTQ CTS Process Function Process Step Key Process Input Potential Failure Mode Potential Failure Effects Hazard Tag r Potential Causes C Current Controls E Actions Recommended Resp. Actions Taken E C E P
N
i C T V C T N
t
y

How often does cause or

FM occur?

cause or FM?
Critical to Critical to Safety: Operation Name for Description of step What is the Key Process In what ways does the Key What is the impact on the Key Unique Identifier for the How What causes the Key What are the existing controls and What are the actions for reducing the Whose What are the completed

How well can you detect

Quality Risk documents listed Manufacturing task within operation Input? Input go wrong? Output Variables (Customer hazard severity Input to go wrong? procedures (inspection and test) that occurrence of the Cause, or improving Responsible for actions taken with the
in this column must Requirements) or internal effects prevent either the cause or the Failure detection? Should have actions only on the recalculated RPN? Be
be reviewed prior to requirements? the Mode? Should include an SOP high RPN's or easy fixes. recommended sure to include
making any changes process number. action? completion month/year
to procedures in Key
Process Input or
Current Controls

Verification Scanner faulty/damaged scanner does not scan N/A malfunction PM as per G-AMFG-1180-00 N/A N/A N/A
8 2 2 32
barcode correctly
Operator scans wrong label mismatch N/A Operator error Scanner verified to detect label N/A N/A N/A
8 4 2 64
label/DHR mismatch,PM as per G-AMFG-1180-00
Incorrect completion of Compliance Issues. N/A Process instruction not Chaecked at product release. N/A N/A N/A
4 2 2 16
DHR's followed.
Missing labels - Dangerous Foob; shipment held up at N/A Process operative error Training; 10039897. Labelling is checked N/A N/A N/A
good and last charge customs; 5 10 per pack procedure and mainline 1 50 - - - -
battery label procdure.
Cosmetic issue with unit FOOB; N/A Process operative error Training; 10039897 N/A N/A N/A
4 10 2 80 - - - -
Correct revision of labels lack of traceability of label N/A Incomplete material Revision of labels controlled on Agile; N/A N/A N/A
revision clearance after change revision of labels recorded on DHR for
5 in label revision 3 traceability; All labels will be new revision 5 75 - - - -
for P4.0
Process instruction Cannot pack unit N/A 7 Incomplete review 3 Agile review and approval 3 63 N/A N/A N/A - - - -
Operator Operator: does not pack Customer does not receive N/A Operator: does not Check in DHR N/A N/A N/A
Electrical Safety Test report Electrical Safety Test report 2 follow test procedure 10 2 40 - - - -
correctly
Software Download Software Download Procedure: PB560, Procedures misinterpreted Software is not downloaded or N/A Lack of review of Procedure is ECO controlled in Agile; N/A N/A N/A
10039897 due lack of clarity; verified to be downloaded procedure process is validated - LR0005-3;
incorrectly written correctly Successful download message is
checked when download is complete.
6 10 Test process will not execute successfully 1 60 - - - -
without product software loaded and S/W
version are recorded on DHR later in
procedure

Operator Operator: does not follow Operator does not complete N/A Operator doesn't follow Operator trained and signed off on N/A N/A N/A
software download product software download procedure - power procedure per G-QAP017. Process is
procedure successfully switch in wrong position validated - LR0005-3; Successful
for ST10 download, download message is checked when
6 wrong com port 10 download is complete. Download app 1 60 - - - -
selected for either cannot start with wrong com port number.
download app, Test process will not execute successfully
download cable not without product software loaded
connected

Process task Operator: does not follow Distribution centre cannot N/A Operator error. Training; 10039897. Check in pack ALARP - Review PFMEA as part of G- PB560 TBD
process and ventilator is not process vent as there is procedure. Check in DHR. Check on QAP056. Review procedure vs practice. Check Manufacturing
assigned to correct region conflicting information on backflush log. customer complaint rates. Revise occurance Engineer.
shipping carton. 6 10 2 120 rating accordingly. Implementation of scanner - - - -
verification check to ensure all labelling is
correct.
Line Clearance Line Clearance Operator Parts that do not impact Cosmetic impact. N/A Incomplete line Unit is visually checked at pack and N/A N/A N/A
device functionality that are clearance differences between PB540/560 and
specific to PB540 or PB520 4 10 PB520 unique parts are easily 1 40 - - - -
are used on PB560 detectable.
Line Clearance Line Clearance Operator Labeling that is specific to Incorrect indications on N/A Incomplete line Labeling will not impact functionality. N/A N/A N/A
PB540 or PB520 are used labeling. clearance Symbols used are common between
on PB560 4 10 PB540/560/520. Labeling is verified at 1 40 - - - -
pack. PB540/520 serial number formats
will not pass PB560 functional test.

Page 18 of 21 10037310U00
It is not deemed necessary to complete a cause
and effect matrix for the process as all the key
input and output variables identified in the
process flow map are considered significantly
important as to be analysed by the PFMEA

10037310, Rev U
 Control Plan

Core Team: Date (Orig): 14-Apr-10

Date (Rev): U

Process Cpk /
Spec Date Measure
Process %R&R or Current Control Method (from
Input Output (LSL, (Sample ment Who Where When Reaction Plan
Step P/T FMEA)
USL, Size) System
Target)
N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A

Page 1 of 1 10037310U00
 Reference Documents

Document Number Document Title

4096600 560 VENTILATOR BOM
10021625 TUBE CUTTING PROCEDURE
10021626 LOG - PB540/PB560/PB520 TUBE CUTTING
10021754 PB540/560/520/GEN1/POWERPACK PRODUCT RELEASE AUTHORISATION
10022945 PB540/PB560 TEST DC POWER CABLE
10026042 SOFTWARE REFERENCE DRAWING OPEN VENT , PB 540
10036007 PB560 SYSTEM CALIBRATION AND TEST PROCEDURE
10038461 PB560 DHR
10039030 PB560, SYSTEM FINAL TEST PROCEDURE
10039032 PB560 PEDIATRIC VOLUME AND PRESSURE TEST SCRIPT
10039033 PB560 ADULT VOLUME AND PRESSURE TEST SCRIPT
10039034 SOFTWARE REFERENCE DRAWING PB560 CPU MAIN
10039196 ASSY, PB560, OUS, TOP LEVEL
10039304 PB500 Series System Calibration/ Final Test Verification Log
10039897 PB560 PACK PROCEDURE
10048361 ORM, PARAMETERS LOG FOR PERIMETER SEALING MACHINE #20
10051250 PB560 MAIN-ASSEMBLY 4 PROCEDURE.
10076002 PB500 ELECTRICAL SAFETY TEST & BUZZER CARD CHARGE PROCEDURE
10095161 PB560 ASSEMBLY PROCEDURE 1
10095162 PB560 ASSEMBLY PROCEDURE 2  
10095163 PB560 ASSEMBLY PROCEDURE 3
10149038 VERIFICATION SCANNER OPPERATING PROCEDURE
G-AMFG-1037-130 M/S
G-AMFG-1110-00 TEMPERATURE & HUMIDITY PROC.
G-AMFG-1180-00 PREVENTIVE MAINTENANCE-TESTER & TEST STANDS
G-QAP004 CHANGE CONTROL PROCEDURE
G-QAP007 VENDOR APPROVAL
G-QAP012 5100 FLUKE METER
G-QAP017 TRAINING PROCEDURE
G-QCAL019 PERFLOW MICROMANOMETER
G-QCAL030 TORQUE TOOL
G-QCAL041 AIR IONISERS
G-QCAL234 AIR IONISER GUN
II019105 II,QUALITY STD FOR COSMETIC CRITERIA OF MECH FAB COMPONENTS
IPC-A-610 CERTIFICATION PROGRAM FOR IPC-A-610E
QS00002016 UDI Barcode Grading Verification procedure

10037310U00