Document Tracking:

Dept.
Quality Department
Responsible:
User is responsible for obtaining current revision prior to using this document.

1.0 Purpose
This procedure defines the methods to be used for:
1.1 Variable and attribute sampling and inspection of raw materials,
assemblies, in process testing or finished goods.
2.0 Scope
2.1 This procedure applies to all sampling inspection activities at Rancho
Cordova and Costa Rica sites unless otherwise specified in documents.
3.0 Reference Documents
4.0 Definitions
4.1 Steady: The condition in which the production or delivery/supply of the
item for inspection in the ERP system (query quarantine orders or under
production route transaction) is free from fluctuation, is continuous,
regular, and even.
4.2 Irregular: The condition in which the production or delivery/supply of the
item inspection in the ERP system (query quarantine orders) has no
regular pattern.
4.3 C=0 Sampling Plan: Accept on zero, reject on 1 per Zero Acceptance
Number Sampling Plans.
4.4 Acceptable Quality Level (AQL): When considering a continuous series
of lots/batches, the AQL is the quality level which is the limit of a
satisfactory process average.
5.0 Responsibilities
5.1 Inspectors or Quality Technician:
Are responsible for ensuring that their training records are current and that
only official, current, controlled documents are used to inspect and test
materials, components, sub-assemblies and finished goods.
5.2 Quality Supervisors or Quality Engineer:
Are responsible for their own training, and training of inspection personnel,
and for ensuring that current and controlled documentation is used for
inspection and testing of all the materials, components, sub-assemblies,
and final assemblies under their control.
6.0 Materials/Equipment Used
6.1 Product Material (For Systems only)

Description Part Number

N/A N/A

6.2 Equipment/Tools

Description Part Number

N/A N/A
 6.3 Floor Stock

Description Part Number

N/A N/A

7.0 Procedures:
7.1 Unless otherwise specified, the attribute and variable sampling plans
(based on ANSI/ASQC Z1.4.-2003 (rev 2013) and ANSI/ASQ Z1.9.-2003
(rev 2013)) listed in Tables 3 through 5 shall be used for inspection
sampling and lot release inspection and testing.
NOTE: The variable sampling tables (Tables 3b, 4b and 5b) included in
this procedure are included for information only at this time. Volcano
currently only uses Tables 3a, 4a and 5a. When variable data is collected,
Volcano uses the sample sizes in the attribute tables and treats the data
as an attribute to determine if it meets the specified criteria or not.
7.2 Switching Rules: The following switching rules from ANSI/ASQ Z1.4 and
ANSI/ASQ Z1.9 may be utilized unless otherwise specified.
Note: These rules are intended primarily to be used for a
continuing series of lots. There cannot be simultaneous inspections
of the same item number because the outcome of one inspection
could affect the inspection criteria of another one.
7.2.1 Normal to Tightened: When two out of five consecutive lots or
batches have been rejected on original inspection.
7.2.2 Tightened to Normal: When five consecutive lots or batches
have been accepted on original inspection.
7.2.3 Normal to Reduced: When:
a. The preceding 10 lots or batches have been accepted; and
b. The total number of non-conforming units (or non-
conformities) in the samples from the preceding 10 lots or
batches is equal or less than the applicable limit number
given in Table 2.
c. Production is at steady rate (see section 4.1); and
d. Reduced inspection is approved by QA Manager or
designee.
 7.2.4 Reduced to Normal: When:
a. A lot or batch is rejected; or
b. A single (1) lot or batch is accepted but the number of
nonconformities found lies between the accept and reject
numbers of the plan; or
c. Production becomes irregular or delayed (see section 4.2);
or
d. Other conditions warrant that normal inspection be
instituted.
7.2.5 For raw material received for first time related to new product
introduction (NPI), the quality inspection must initiate in tightened,
then apply rule “Tightened to Normal”

7.3 Quality Receiving Inspection (QRI): When multiple outer containers are
received in QRI for any one component, a representative sample must be
taken.
7.3.1 To ensure representative samples are taken, QRI will use the
following rule to determine the number of outer containers from
which to obtain the sample:
Number of Containers to Sample (NCS) = √(N) + 1, where
N: total number of outer containers
NOTE: If the calculated NCS is not a whole number, round up to
the nearest whole number.
Table 9 describes the number of outer containers to be sampled
based on the total number of outer containers received.
7.3.2 Components shipped in bulk containers will be sampled in a
random manner that ensures the acquired sample is
representative of the entire container. For example, this may
require that the container be shaken or stirred prior to obtaining
the sample.
7.3.3 QRI personnel must verify the part risk in the PLM system, the
component/part risk is defined according to the following
classification:
Z: low risk
Y: medium risk
X: high risk
W: critical risk
7.3.4 The inspection level (AQL) is defined according to the
component/part risk, see Table 1
Table 1
 Inspection Level Based on Component/Part Risk Level

Component/Part Risk Level Severity

Inspection Level
Z Y X W

Inspection Inspection Inspection Inspection

AQL
Level 4.0 Level 2.5 Level 1.0 Level 0.65

7.4 Quality Final Inspection (Quality Representative):

7.4.1 Attribute Packaging and Labeling Inspections: Quality
Representative is to use Table 10 for attribute packaging and
labeling inspections.
7.4.1.1 Switching rules are allowed for this inspection.
7.4.1.2 Quality Representative will document the type
of sampling plan used for each lot on Form,
102-0300.47 (Quality Final Inspection
Summary). One form must be completed per
disposable product family and per part number
for Systems part inspections.
7.4.1.3 Record Disposables packaging and labeling
inspections on Form, Packaging Quality
Inspection Log 801098-001
 7.4.2 Pouch Peel Testing: Data shall be recorded on the appropriate tab
of Form, Product Acceptance Release Data, 102-0300.57 for
Rancho Cordova or 102-0300.145 for Costa Rica.
7.4.2.1 Sample Size: Refer to 316-0200.08 (WI, Final Product
Release, Disposables) for Rancho Cordova or 102-
0299.02 (WI, Quality in Process Inspection) for Costa
Rica, and Table 6. As a business decision, switching
rules are not allowed for Pouch Peel Testing.
7.4.2.2 Perform testing per 316-0200.04 (WI, Use of Instron for
Final Release Testing) for Rancho Cordova or
QD001000460 (WI, Use of the Instron for Testing
Product-CR).
7.4.2.3 Acceptance Criteria: The following two acceptance
criteria must be met:
1: Any pouch peel test which falls out of specification
(Pull Strength must be ≥ 0.75 lbf for all products) will be
reason to reject the batch/lot. If all test samples fall within
specification, then acceptance criterion 2 and the
associated pass/fail criteria apply.

2: From the sample data, calculate:

𝐗 𝐋𝐒𝐋
, where
𝐬

: Data mean
LSL: Lower specification limit (equals 0.75 lbf)
s: Standard deviation
Refer to Table 6 for the k value that corresponds to
the sample size being tested.
𝐗 𝐋𝐒𝐋
If: ≥ k, then the lot is accepted
𝐬

𝐗 𝐋𝐒𝐋
If: ˂ k, then the lot is rejected
𝐬

If any test does not meet these two acceptance

criteria, save the failed specimen and all pouches.
Initiate an OOSR per WI 801535-001(for Rancho
Cordova) or WI QD001000543 (for Costa Rica).
7.5 The following rules apply to Eagle Eye Platinum ST (PN 400-
0200.141) Distal Tip Pull testing only.
7.5.1 Sampling Plan: Utilize Table 7. Implement Normal Inspection to
launch this sampling plan, and follow the switching rules in section
7.2.
7.5.2 Quality Representative will document the type of sampling plan
used for each lot on Form, Quality Final Inspection Summary102-
0300.47.
7.5.3 Acceptance Criteria: The following two acceptance criteria must be
met:
1: Any distal tip pull test which falls out of specification (Pull
Strength ≥ 0.67 lbf) will be reason to reject the batch/lot. If all
test samples fall within specification, then acceptance criterion
2 and the associated pass/fail criteria apply.
2: From the sample data, calculate:
𝐗 𝐋𝐒𝐋
, where
𝐬

𝐗̅ is the data mean,

𝐋𝐒𝐋 = 0.67 lbf, and
𝐬 is the standard deviation

Refer to Table 7 for the k value that corresponds to

the sample size being tested.

𝐗 𝐋𝐒𝐋
If: 𝒌, the lot is accepted
𝐒

𝐗 𝐋𝐒𝐋
If: 𝒌, the lot is rejected
𝐒

If any test does not meet these two acceptance criteria, save
the failed specimen and all pouches. Initiate an OOSR (Out
of Specification Report) per WI 801535-001(for Rancho
Cordova) or WI QD001000543 (for Costa Rica).
7.6 The following rules apply to PV0.18 (PN 400-0200.285 / K8886700)
Distal Tip for Scanner to Shaft Pull Test only.
7.6.1 Sampling Plan: Use Table 8. Implement Normal Inspection to
launch this sampling plan, and follow the switching rules in section
7.2.
7.6.2 Quality Representative will document the type of sampling plan
used for each lot on Form, Quality Final Inspection Summary,
102-0300.47.
7.6.3 Acceptance Criteria: The following acceptance criteria (two
criterions) must be met:
1: Any Scanner to Shaft Pull Test which falls out of specification
(Pull Strength ≥ 1.124 lbf) will be reason to reject the batch/lot.
If all test samples fall within specification, then acceptance
criterion 2 and the associated pass/fail criteria apply.
2: From the sample data, calculate:
𝐗 𝐋𝐒𝐋
, where
𝐬

𝐗̅ is the data mean of the sample,

𝐋𝐒𝐋 = 1.124 lbf, and
𝐬 is the standard deviation of the sample

Refer to Table 8 for the k value that corresponds to

the sample size being tested.
𝐗 𝐋𝐒𝐋
If: 𝒌, the lot is accepted
𝐒
𝐗 𝐋𝐒𝐋
If: 𝒌, the lot is rejected
𝐒

If any of test does not meet the acceptance criteria (two criterions), save
the failed specimen and all pouches. Initiate an OOSR (Out of
Specification Report) per WI 801535-001(for Rancho Cordova) or WI
QD001000543102 (for Costa Rica).
7.6.4 NCRs can be differentiated (e.g., dimensional, paperwork);
paperwork NCRs may not necessarily cause a lot to be
considered unacceptable. The MRB, through the NCR process,
will determine if a lot is considered unacceptable from a sampling
plan aspect.

7.7 The following rules apply to PV0.035 (PN 400-0200.272 / 420-

0200.173) Guide Wire Movement Test only.
 7.7.1 Normal Inspection Sampling Plan: Use Table 3a for attributes, and
follow the switching rules in section 7.2.
7.7.2 Reduced Inspection Sampling Plan: Use Table 5a for attributes,
and follow the switching rules in section 7.2.
7.7.3 Tightened Inspection Sampling Plan: use table 4a for attributes
and follow the switching rules in section 7.2.
7.7.4 Quality Representative will document the type of sampling plan
used for each lot on Form, Quality Final Inspection Summary,
102-0300.47.
7.7.5 Acceptance Criteria: The following acceptance criteria (two
criterions) must be met:
7.7.6 The mandrel must pass completely through the guide lumen,
without arching.
7.7.7 If any of test does not meet the acceptance criteria (two
criterions), save the failed specimen and all pouches. Initiate an
OOSR (Out of Specification Report) per WI 102-0200.94 (for
Costa Rica).
7.7.8 NCRs can be differentiated (e.g., dimensional, paperwork);
paperwork NCRs may not necessarily cause a lot to be
considered unacceptable. The MRB, through the NCR process,
will determine if a lot is considered unacceptable from a sampling
plan aspect.
7.8 The following rules apply to Capnography Sensor assemblies and
Sleep & Respiratory Care Assemblies only.
7.8.1 Use Table 11 for sample size selection.
7.8.2 Follow to the applicable Quality in Process Inspection procedure
or Quality Final Release procedure to select the AQL.
7.8.3 Select the sample size according to the batch/lot size.
 Table 2
Limit Numbers for Reduced Inspection

Number of sample Acceptable Quality Level (AQL)

units from last 10
0.65 1.0 2.5 4.0
lots or batches
30 - 49 * * * *
50 – 79 * * * 0
80 – 129 * * 0 0
130 – 199 * * 0 2
200 – 319 * 0 2 4
320 – 499 0 0 4 8
500 – 799 0 2 7 14
800 – 1249 2 4 14 24
1250 – 1999 4 7 24 49
2000 – 3149 8 14 40 68
3150 – 4999 14 24 67 111
5000 – 7999 25 40 110 181
8000 – 12499 42 68 181
12500 – 19999 69 110
20000 - 31499 115 181

* Denotes insufficient number of sample units from last 10 lots or batches for reduced
inspection for this AQL. In this instance more than ten lots or batches may be used for
the calculation provided that the lots or batches used are the most recent ones in
sequence, that they all have been on normal inspection, and that none has been
rejected their original inspection.
 Table 3a
NORMAL ATTRIBUTE INSPECTION SAMPLING PLAN
BATCH/LOT SIZE
INSPECTION TYPE 501- 1201- 3201- 10001- 35001-
2-8 9-15 16-25 26-50 51-90 91-150 151-280 281-500
1200 3200 10000 35000 150000
INCOMING MATERIALS 20 or
100% 100% 20 20 20 20 20 20 80 80 125 200
(Inspection Level I, 100%
0/1 0/1 0/1 0/1 0/1 0/1 0/1 0/1 1/2 1/2 2/3 3/4
0.65) 0/1
INCOMING MATERIALS 100% 13 or 100% 13 13 13 13 13 13 50 50 80 125 200
(Inspection Level I, 1.0) 0/1 0/1 0/1 0/1 0/1 0/1 0/1 0/1 1/2 1/2 2/3 3/4 5/6
INCOMING MATERIALS 5 or 100% 5 5 5 5 5 20 20 32 50 80 125 200
(Inspection Level I, 2.5) 0/1 0/1 0/1 0/1 0/1 0/1 1/2 1/2 2/3 3/4 5/6 7/8 10/11
INCOMING MATERIALS 3 or 100% 3 3 3 3 15 15 20 32 50 80 125 200
(Inspection Level I, 4.0) 0/1 0/1 0/1 0/1 0/1 1/2 1/2 2/3 3/4 5/6 7/8 10/11 14/15
IN-PROCESS 100% 13 or 100% 13 13 13 13 13 13 50 50 80 125 200
(Inspection Level I, 1.0 % 0/1 0/1 0/1 0/1 0/1 0/1 0/1 0/1 1/2 1/2 2/3 3/4 5/6
NOTE: For lot sizes greater than 150,000, contact Quality Representative for sample size.
Table 3b
NORMAL VARIABLE INSPECTION SAMPLING PLAN
BATCH/LOT SIZE

INSPECTION TYPE 35001-

16- 281- 401- 501- 1201- 3201- 10001-
2-8 9-15 26-50 51-90 91-150 151-280 15000
25 400 500 1200 3200 10000 35000
0
Sample 4 or
4 4 5 7 10 15 20 25 35 50 75 100 150
size 100%
INCOMING MATERIALS
(Inspection Level II, AQL 1.0) Acceptabili
ty constant 1.46 1.46 1.46 1.52 1.62 1.71 1.79 1.83 1.85 1.89 1.94 1.98 2.00 2.03
“k”
Sample 4 or
4 4 5 7 10 15 20 25 35 50 75 100 150
size 100%
IN-PROCESS
Acceptabili
(Inspection Level II, AQL1.0)
ty constant 1.46 1.46 1.46 1.52 1.62 1.71 1.79 1.83 1.85 1.89 1.94 1.98 2.00 2.03
“k”

NOTE: For lot sizes greater than 150,000, contact Quality Representative for sample size.
 Table 4a
TIGHTENED ATTRIBUTE INSPECTION SAMPLING PLAN
BATCH/LOT SIZE
INSPECTION TYPE 35001-
26- 501- 1201- 3201- 10001-
2-8 9-15 16-25 51-90 91-150 151-280 281-500 15000
50 1200 3200 10000 35000
0
32 or
INCOMING MATERIALS 100% 100% 100% 100 32 32 32 32 32 125 125 125 200
(Inspection Level I, 0.65) 0/1 0/1 0/1 % 0/1 0/1 0/1 0/1 0/1 1/2 1/2 1/2 2/3
0/1
INCOMING MATERIALS 100% 100% 20 or 100% 20 20 20 20 20 80 80 80 125 200
(Inspection Level I, 1.0) 0/1 0/1 0/1 0/1 0/1 0/1 0/1 0/1 1/2 1/2 1/2 2/3 3/4
INCOMING MATERIALS 100% 8 8 8 8 8 32 32 32 50 80 125 200
(Inspection Level I, 2.5) 0/1 0/1 0/1 0/1 0/1 0/1 1/2 1/2 1/2 2/3 3/4 5/6 8/9
INCOMING MATERIALS 5 or 100% 5 5 5 5 20 20 20 32 50 80 125 200
(Inspection Level I, 4.0) 0/1 0/1 0/1 0/1 0/1 1/2 1/2 1/2 2/3 3/4 5/6 8/9 12/13
IN-PROCESS 100% 100% 20 or 100% 20 20 20 20 20 80 80 80 125 200
(Inspection Level I, 1.0) 0/1 0/1 0/1 0/1 0/1 0/1 0/1 0/1 1/2 1/2 1/2 2/3 3/4

NOTE: For lot sizes greater than 150,000, contact Quality Representative for sample size.
Table 4b
TIGHTENED VARIABLE INSPECTION SAMPLING PLAN
BATCH/LOT SIZE

INSPECTION TYPE 35001-

9- 16- 281- 401- 501- 1201- 3201- 10001-
2-8 26-50 51-90 91-150 151-280 15000
15 25 400 500 1200 3200 10000 35000
0
Sample 5 or
INCOMING MATERIALS 5 5 5 7 10 15 20 25 35 50 75 100 150
size 100%
(Inspection Level II,
Acceptability 1.6
AQL 1.0 %) constant “k” 1.65 1.65 1.65 1.75 1.84 1.92 1.96 1.98 2.03 2.07 2.12 2.14 2.18
5
Sample 5 or
IN-PROCESS 5 5 5 7 10 15 20 25 35 50 75 100 150
size 100%
(Inspection Level II,
Acceptability 1.6
AQL1.0 %) constant “k” 1.65 1.65 1.65 1.75 1.84 1.92 1.96 1.98 2.03 2.07 2.12 2.14 2.18
5

NOTE: For lot sizes greater than 150,000, contact Quality Representative for sample size.
Table 5a
REDUCED ATTRIBUTE INSPECTION SAMPLING PLAN
BATCH/LOT SIZE
 35001-
501- 1201- 3201- 10001-
INSPECTION TYPE 2-8 9-15 16-25 26-50 51-90 91-150 151-280 281-500 15000
1200 3200 10000 35000
0
INCOMING MATERIALS 100% 8 8 8 8 8 8 8 8 32* 32* 50* 80*
(Inspection Level I, 0.65) 0/1 0/1 0/1 0/1 0/1 0/1 0/1 0/1 1/1 0/2 0/2 1/3 1/4
INCOMING MATERIALS 5 0 100% 8 8 8 8 8 8 8 20* 20* 32* 50* 80*
(Inspection Level I, 1.0) 0/1 0/1 0/1 0/1 0/1 0/1 0/1 0/1 0/2 0/2 1/3 1/4 2/5
INCOMING MATERIALS 2 2 2 2 2 2 8* 8* 13* 20* 32* 50* 80*
(Inspection Level I, 2.5) 0/1 0/1 0/1 0/1 0/1 0/1 0/2 0/2 1/3 1/4 2/5 3/6 5/8
INCOMING MATERIALS 2 2 2 2 2 5* 5* 8* 13* 20* 32* 50* 80*
(Inspection Level I, 4.0) 0/1 0/1 0/1 0/1 0/1 0/2 0/2 1/3 1/4 2/5 3/6 5/8 7/10
IN-PROCESS 100% 8 8 8 8 8 8 8 20* 20* 32* 50* 80*
(Inspection Level I, 1.0) 0/1 0/1 0/1 0/1 0/1 0/1 0/1 0/1 0/2 0/2 1/3 1/4 2/5

* If reduced inspection acceptance number is exceeded, but rejection number is not reached, then accept the lot, but reinstate normal inspection.
NOTE: For lot sizes greater than 150,000, contact Quality Representative for sample size.
Table 5b
REDUCED VARIABLE INSPECTION SAMPLING PLAN
BATCH/LOT SIZE

INSPECTION TYPE 35001-

16- 281- 401- 501- 1201- 3201- 10001-
2-8 9-15 26-50 51-90 91-150 151-280 15000
25 400 500 1200 3200 10000 35000
0
Sample 4 or
4 4 4 4 4 5 7 10 15 20 25 30 50
INCOMING MATERIALS size 100%
(Inspection Level II, AQL 1.0) Acceptabili
ty constant 1.34 1.34 1.34 1.34 1.34 1.34 1.40 1.50 1.59 1.65 1.69 1.72 1.73 1.80
“k”
Sample 4 or
4 4 4 4 4 5 7 10 15 20 25 30 50
IN-PROCESS Size 100%
(Inspection Level II, AQL1.0) Acceptabili
ty constant 1.34 1.34 1.34 1.34 1.34 1.34 1.40 1.50 1.59 1.65 1.69 1.72 1.73 1.80
“k”

NOTE: For lot sizes greater than 150,000, contact Quality Representative for sample size.
Table 6

QFI Pouch Peel Final Release Sampling Plan

 151- 281- 401- 1201- 3201- 10001- 35001-
2-8 9-15 16-25 26-50 51-90 91-150 501-
280 400 500 3200 10000 35000 150000
Inspection / Batch/Lot size (B) (B) (C) (D) (E) (F) 1200
(G) (H) (I) (K) (L) (M) (N)
                  (J)        
Number of
pouches 2 2 2 2 2 3 3 4 5 7 10 15 20 30
required

POUCH PEEL
Pouch peel
VARIABLE
sample size
TESTING 5 5 5 5 7 10 15 20 25 35 50 75 100 150
(Total Data
(Inspection Level
Points)
II, AQL 0.65%)

Acceptability
constant 1.65 1.65 1.65 1.65 1.75 1.84 1.92 1.96 1.98 2.03 2.07 2.12 2.14 2.18
“k”
 Table 7

VARIABLE SAMPLING FOR

EAGLE EYE PLATINUM ST TIP PULL
BATCH/LOT SIZE
INSPECTION TYPE
2-8 9-15 16-25 26-50 51-90 91-150 151-280

Sample Size 4 4 4 4 4 4 5
REDUCED
(Inspection Level II, Acceptability
1.46 1.46 1.46 1.46 1.46 1.46 1.52
AQL 0.65) Constant (k)
SS Code B B C D E F G

Sample Size 5 5 5 5 7 10 15
NORMAL
(Inspection Level II, Acceptability
1.65 1.65 1.65 1.65 1.75 1.84 1.92
AQL 0.65) Constant (k)
SS Code B B C D E F G

Sample Size 5 5 5 5 7 10 15
TIGHTENED
(Inspection Level II, Acceptability
1.77 1.77 1.77 1.77 1.88 1.98 2.06
AQL 0.65) Constant (k)
SS Code B B C D E F G

NOTE: EEPST AQL = 0.65 selected for a reliability level of 99% for tensile strength.
Unless otherwise specified, EEPST tip pull samples are to be taken per lot.
 Table 8
VARIABLE SAMPLING FOR PV.018 SHAFT TO SCANNER PULL TEST
BATCH/LOT SIZE
INSPECTION TYPE
2-8 9-15 16-25 26-50 51-90 91-150 151-280

REDUCED Sample Size 4 4 4 4 4 4 5

(Inspection Level II,
Acceptability
AQL 0.65) 1.34 1.34 1.34 1.34 1.34 1.46 1.52
Constant (k)
NORMAL Sample Size 5 5 5 5 7 10 15
(Inspection Level II,
Acceptability
AQL 0.65) 1.65 1.65 1.65 1.65 1.75 1.84 1.92
Constant (k)
TIGHTENED Sample Size 5 5 5 5 7 10 15
(Inspection Level II,
Acceptability
AQL 0.65) 1.65 1.65 1.65 1.65 1.75 1.84 1.92
Constant (k)

NOTE: PV.018 AQL = 0.65 selected for a 99% confidence level for the tensile strength. The PV.018 Shaft to Scanner Pull test
samples must be obtained for each lot.
 Table 9
QRI Sample Acquisition from Multiple Containers

Number of Outer
Total Number of Outer Containers
Containers Received
to be Sampled
(N)
(NCS)
1-2 All
3-4 3
5-9 4
10-16 5
17-25 6
26-36 7
37-49 8
50-64 9
65-81 10
82-100 11
101-121 12
122-144 13
145-169 14
170-196 15
197-225 16
226-256 17

Table 10

QFI ATRIBUTE SAMPLING PLAN

 Inspection Level II, AQL 1.0 %

NOTE: For lot sizes greater than 150,000, contact Quality Representative for sample size.

151‐ 281‐ 501‐  1201‐ 3201‐ 10001‐ 35001‐

Inspection / Batch/Lot size  2‐8  9‐15  16‐25  26‐50  51‐90  91‐150 
280  500  1200  3200  10000  35000  150000 
  (B)  (B)  (C)  (D)  (E)  (F) 
(G)  (H)  (J)  (K)  (L)  (M)  (N) 
PACKAGING AND LABEL    13 or 
 100%  13  13  13  13  50  50  80  125  200  315  500 
100% 
NORMAL  
0/1  0/1  0/1  0/1  0/1  1/2  1/2  2/3  3/4  5/6  7/8  10/11 
0/1 
PACKAGING AND LABEL    20 Or     
100%  100%  20  20  20  80  80  80  125  200 
100%  315  500 
TIGHTENED      
0/1  0/1  0/1  0/1  0/1  1/2  1/2  1/2  2/3  3/4 
0/1  5/6  8/9 
PACKAGING AND LABEL        125* 
5 or 100%   5  5  5  5  5  20*  20*  32*  50*  80*    200* 
 
 
REDUCED   3/6 
0/1  0/1  0/1  0/1  0/1  0/1  0/2  0/2  1/3  1/4  2/5  5/8 

* If the acceptance number has been exceeded, but the rejection number has not been reached accept the lot but reinstate normal inspection
 Table 11
C=0 Sampling Plan Selection Guidelines
C=0 Sampling Plan forC=0 Sampling
In-Process Plan and QA Release Inspection
Inspection,
AQL
.010 .015 .025 .040 .065 .10 .15 .25 .40 .65 1.0 1.5 2.5 4.0 6.5 10.0 Lot/Batch Size
* * * * * * * * * * * * 5 3 3 3 2 to 8
* * * * * * * * * * 13 8 5 3 3 3 9 to 15
* * * * * * * * * 20 13 8 5 3 3 3 16 to 25
* * * * * * * * 32 20 13 8 7 7 5 3 26 to 50
* * * * * * 80 50 32 20 13 13 11 8 5 4 51 to 90
* * * * * 125 80 50 32 20 19 19 11 9 6 5 91 to 150
* * * * 200 125 80 50 32 29 29 19 13 10 7 6 151 to 280
* * * 315 200 125 80 50 48 47 29 21 16 11 9 7 281 to 500
* 800 500 315 200 125 80 75 73 47 34 27 19 15 11 8 501 to 1200
1250 800 500 315 200 125 120 116 73 53 42 35 23 18 13 9 1201 to 3200
1250 800 500 315 200 192 189 116 86 68 50 38 29 22 15 9 3201 to 10,000
1250 800 500 315 300 294 189 135 108 77 60 46 35 29 15 9 10,001 to 35,000
1250 800 500 490 476 294 218 170 123 96 74 56 40 29 15 9 35,001 to 150,000
1250 800 750 715 476 345 270 200 156 119 90 64 40 29 15 9 150,001 to 500,000
1250 1200 1112 715 556 435 303 244 189 143 102 64 40 29 15 9 500,000 and Over
.010 .015 .025 .040 .065 .10 .15 .25 .40 .65 1.0 1.5 2.5 4.0 6.5 10.0 Lot/Batch Size

Note - * Indicates entire lot must be inspected