PURPOSE

The CAPA program is intended to eliminate or minimize actual or potential

non-conformities. The level of corrective action will be appropriate to the
magnitude of the problem and commensurate with the risk. A major quality
control function is the documentation of the detection, measurement, and
follow-up on quality related actual and potential non-conformities to ensure
that prompt and effective corrective action is taken. The corrective and
preventative action system (CAPA) provides a system for resolution of
quality issues, confirming that the associated corrective action has been
effective, and that preventative action has been identified and implemented.

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SCOPE

This procedure applies to adverse trends in quality and safety performance

indicators.

DEFINITIONS

CAPA SYSTEM: A systematic approach to review quality system data and

information to identify, correct and prevent nonconformities.

CORRECTION: The remedy of an existing nonconformity to restore compliance

to the quality system.

CORRECTIVE ACTION: Action taken to prevent recurrence of an existing

nonconformity.

PREVENTATIVE ACTION: Action taken to eliminate the cause of a potential

nonconformity to prevent occurrence.

EVALUATION: A review of quality system data and information related to an

existing or potential nonconformity or trend to determine the need for an
investigation.

INVESTIAGTION: An analysis conducted to determine assignable cause(s) of

an existing nonconformity or trend.

RISK ASSESSMENT: A determination of impact of the nonconformity to

quality and/or regulatory status.

NONCONFORMITY: Any departure from the requirements of the quality system.

DATA SOURCE: Internal and external information sources that feed the CAPA
system. These sources could be from both an exception document or a
tracking or trending system.

TRACKING: A collection of quality system data an information for the

purpose of evaluation and trending.

TRENDING: The evaluation of tracked quality system data and information to

determine if further action is required.

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TREND: A sequence or pattern of quality system data and information that
may indicate a potential shift in compliance to the quality system.

EFFECTIVENESS: The confirmation, after a pre-determined time, that the

corrective or preventive action has restored compliance to the quality
system.

CAUSE: The assignable factor(s) responsible for the nonconformity.

QUALITY SYSTEM: The organizational structure, responsibilities,

procedures, processes, and resources to manage the quality and compliance
of products and services.

VERIFICATION: Confirmation by examination and provision of objective

evidence that specified requirements can be consistently fulfilled
(associated with corrective action).

VALIDATION: Confirmation by examination and provision of objective

evidence that the particular requirements for a specific intended used can
be consistently fulfilled (associated with preventive action).

DPM (DEFECTS PER MILLION): Measure of defects found during quality

assurance final inspection.

DEVIATIONS: Approved and documented temporary deviations to manufacturing

processes.

IQA NCMR (Incoming Material - Non-conforming Material Report): Approved

and documented report describing incoming material that does not meet
specifications as received from the vendor, and associated corrective
action.

NCMR (Non-conforming Material Report): Approved and documented report

describing final product that does not meet specifications, and associated
corrective action.

PCA (Product Complaint Analysis): Investigation of failure generated by

customer complaints.

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PROCEDURE

A. OVERVIEW

If quality or safety performance indicators indicate an adverse

trend, or by management discretion, a corrective and preventative
action report (CAPAR) shall be issued to the appropriate function.
The plant function shall convene a process improvement team (PIT).
The PIT team will report and be accountable to management review on a
monthly basis. Verification, or where appropriate validation of
corrective action and preventative action, will be presented to
management review and the CAPAR will be closed.

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B. CAPA DATA SOURCES

CAPA data sources are designed to analyze processes, work operations, quality records,
complaints, returned product and other sources of quality data to identify existing and potential
causes of non-conforming product, or other quality problems. These CAPA data sources, associated
documents, metrics, tracking, trending, responsible person and timing of management review are as
follows:

GN . 11-03 FORM PLANT CAPA CONTROLLING TRACKING METRIC/TRACKING TITLE OF TIMELY MGMT
CAPA DATA TYPE DATA SOURCES DOCUMENT METHOD METHOD FOR RESPONSIBLE REVIEW
SOURCES PLANT UNF./UNACCEPTABLE PERSON MECHANISM
TRENDS BOP.X.1000-0006
Complaints I PCA CAPARS BOP.X.2500-0024 BOP.X.1000-0013 Unacceptable trends Quality Systems Monthly Management
 Customer issued by the determined by Fichers Exact Manager Review Board
 Medwatch Formally Test Meeting
 Field Designated Unit
Service in ,
Reports
 Journal
Articles
 (FDA field
service
reports)

Legal claims I CAPARS issued by N/A BOP.X.1000-0013 Unacceptable trends Quality Systems Monthly Management
Quality Assurance determined by Fichers Exact Manager Review Board
in , Test Meeting

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 GN . 11-03 FORM PLANT CAPA CONTROLLING TRACKING METRIC/TRACKING TITLE OF TIMELY MGMT
CAPA DATA TYPE DATA SOURCES DOCUMENT METHOD METHOD FOR RESPONSIBLE REVIEW
SOURCES PLANT UNF./UNACCEPTABLE PERSON MECHANISM
TRENDS BOP.X.1000-0006
Product I PCA CAPARS BOP.X.2500-0024 BOP.X.1000-0013 PCA CAPARS issued by the Quality Systems Monthly Management
Warranty issued by the /Formally Designated Unit in , Manager Review Board
Formally Meeting
Designated Unit
in ,

Inspections / test NCR DPMs BOP.X.2000-0019 BOP.X.1000-0013 Unacceptable trends Plant QA Manager Monthly Management
data Restrictions BOP.X.2500-0020 determined by Fichers Exact Review Board
 Inprocess NCMR BOP.X.2500-0014 Test Meeting
 Final
Scrap / Yield NCR Restrictions BOP.X.2500-0020 BOP.X.1000-0013 Unacceptable trends Quality Systems Monthly Management
data NCMR BOP.X.2500-0014 determined by monthly Mgr. Review Board
management review Meeting
Process Control NCR Restrictions BOP.X.2500-0020 BOP.X.1000-0013 Unacceptable trends Plant QA Mgr. Monthly Management
data NCMR BOP.X.2500-0014 determined by monthly Review Board
management review Meeting
MWO BOP.X.5300-0041
Incoming NCR Incoming NCMRs BOP.X.2500-0014 BOP.x.1000-0013 Unacceptable trends Quality Systems Monthly Management
Components Restriction BOP.X.2500-0020 determined by monthly Mgr. Review Board
 By supplier Deviation BOP.X.2500-0017 management review Meeting
 By part
number
Equipment data NCR Calibration Alert BOP.X.5600-0005 BOP.X.1000-0013 Unacceptable trends Facilities Mgr. Monthly Management
 Calibration MWO BOP.X.5300-0041 determined by monthly Review Board
 Maintenance PM BOP.X.5300-0035 management review Meeting

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 GN . 11-03 FORM PLANT CAPA CONTROLLING TRACKING METRIC/TRACKING TITLE OF TIMELY MGMT
CAPA DATA TYPE DATA SOURCES DOCUMENT METHOD METHOD FOR RESPONSIBLE REVIEW
SOURCES PLANT UNF./UNACCEPTABLE PERSON MECHANISM
TRENDS BOP.X.1000-0006
Internal Audits I QA Audit Records BOP.X.2500-0013 BOP.X.2500-0013 Unacceptable trends Quality Systems Monthly Management
Regulatory BOP.X.2500-0011 determined by monthly Mgr. Review Board
Inspection management review Meeting
Observations and
follow-up
Device History I Work Order Errors BOP.X.2510-0001 BOP.X.1000-0013 Unacceptable trends Quality Systems Monthly Management
Records determined by monthly Mgr. Review Board
Deviations BOP.X.2500-0017 management review Meeting
Training Records I Monthly Audit BOP.X.1500-0001 BOP.X.1000-0013 Unacceptable trends Quality Systems Monthly Management
Report determined by monthly Mgr. Review Board
management review Meeting
Rework NCR EPWO [Link]-SP-022 BOP.X.1000-0013 Unacceptable trends Quality Systems Monthly Management
Restrictions BOP.X.2500-0020 determined by monthly Mgr. Review Board
Return Goods [Link]-SP-102 management review Meeting
Non-conforming NCR NCMRs BOP.X.2500-0014 BOP.X.1000-0013 Unacceptable trends Quality Systems Monthly Management
materials determined by monthly Mgr. Review Board
management review Meeting

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C. CAPA METRICS AND TRIGGERING THRESHOLD:

The CAPAR will be initiated when an adverse trend or quality issue is

noted in any of the following areas. For this procedure, unless otherwise
specified, a trend will be defined as three months in which an adverse
condition occurs. The data associated with these indicators shall be
retained with Monthly Management Review minutes.

1. Product complaint system (generated by Division)

A. M1 turn around for sample analysis greater than 30 days after
receipt from sterilization.
2. Calibration program (cal alerts past due, missing instruments)
3. Maintenance work order system (approvals open longer than 30 days)
4. Preventative maintenance system (delinquent greater than 30 days)
5. NCMR’s
6. Deviations
7. Restrictions
Note: There are no defined criteria for issuing a restriction.
Restrictions enable employees to flag product for any
reason.
8. Safety performance indicators
Note: Safety performance indicators are included for management
review of safety program.
9. Environmental monitoring (BOP.X.2200-0073)
10. Defects per million
11. Label errors
12. Management discretion
13. Internal audits (audit schedule, past due response review)
Note: The plant manager and operations staff will conduct a
monthly quality system audit review meeting to discuss
internal and external audit observation trends, status, and
closure. CAPARS will be issued on adverse trends or
significant quality system deficiencies. Meeting minutes
will be taken and retained as quality records.

D. ELEMENTS OF CORRECTIVE AND PREVENTIVE ACTION:

Documented corrective and preventive actions needed to demonstrate

implementation of all required changes, justifications, and
investigations.

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 1. Identification of the existing problem (corrective action):

Evaluate the cause and investigate the extent/risk of the problem.

Are other similar products, processes or quality systems affected?
Give rationale or explanation. Where employed, verify appropriate
statistical techniques.

2. Identification of potential problems (preventive action):

If no preventive action is needed, then justify. Evaluate and

investigate the extent/risk of the problem. Are other similar
products, processes or quality systems affected? Give rationale or
explanation. Where employed, verify appropriate statistical
techniques.

3. Where possible, identify the root cause.

4. Determine if corrective and preventive actions were effective and

verified or validated prior to implementation.

5. Follow up and document to ensure that implemented actions are

effective and do not adversely affect the finished product.

NOTE: A correction can occur that does not require further

corrective action when documented with appropriate
justification and approvals. A final product correction
resulting in release or destruction shall require Plant QA
Manager sign-off.

CAPAR MANAGEMENT:

CAPARS will be initiated by completing a CAPAR form that is obtained from

Quality Assurance, a CAPAR tracking number will be assigned.

Note: If it is determined that the CAPAR should be voided after

initiation a written explanation will be maintained in the CAPAR file.

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E. PROCESS IMPROVEMENT TEAM

1. Upon receipt of a CAPAR, the appropriate plant function shall appoint

a process improvement team (PIT) to perform a risk analysis,
investigate and identify corrective and preventative action,
implement the corrective and preventative action, and present
verification or where appropriate validation, of effectiveness of
corrective and preventative action to management review.

2. The team shall identify and report to management review on a monthly

basis resources, milestones and project status, including actual
versus planned completion dates for identified milestones.

3. Attached reporting form (attachment III) or it's equivalent may be

used.

4. All project documentation outlined in this bop, as well as any

related documentation, shall be maintained in a CAPAR project book.
Related documentation includes photocopies of any laboratory notebook
studies, engineering studies and summaries and references to related
validations.

5. Close out documentation shall include:

a. Documentation to demonstrate implementation of all required

changes to methods and procedures.

b. Documentation to demonstrate that training of personnel directly

responsible for assuring the quality of such product or the
prevention of such problems have been supplemented with
information relating to the nature of the problem, cause(s), and
corrective and preventive actions taken.

c. Documentation to demonstrate the method (or protocol) by which

corrective and preventive actions will be verified (or
validated) to ensure that the action is effective and does not
adversely affect the product.

d. Documentation to demonstrate that the verification method or

validation protocol requirements were met or rationale and
justification provided for deviation from expected results as a
prerequisite to investigation closure.

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F. CAPAR CLOSE-OUT

1. The PIT team shall present evidence of verification, or where

appropriate validation of corrective and preventative action to the
monthly management review.

2. Based on trending data, management review shall approve or disapprove

the verification of corrective and preventative action.

3. If disapproved, the CAPAR shall remain open.

4. If approved, the CAPAR shall be closed, with all documentation and an

explanation for closure. The closure date will be recorded on the
appropriate form and approved by the QA Manager.

5. CAPAR project books shall be maintained as part of the quality record

and filed in the quality assurance file.

G. EFFECTIVENESS:

1. CAPARS will be reviewed for effectiveness on a quarterly basis by

determining if there have been any repeat occurrences.

END OF DOCUMENT

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 ATTACHMENT I
CAPA PROCESS FLOW

COMPLAINTS
Division CAPARS Legal Claims, Product
MI Turn Around Time Warranty, Customer, Med
Watch
PLT MGR.
Cal Program PRODUCTION/PR PLT QA MGR
Maint WO OCESS UNIT MGR
PM System CONTROLS
EPWO
Work Order Errors
Training

NCMR
Deviations QUALITY CAPAR MANAGEMENT ASSIGN TO IMPLEMENT MANAGEMENT
Restrictions DATA MANAGEMENT INITIATED REVIEW TASK FORCE
CORRECTIVE VERIFY CAPAR
ACTION EFFECTIVENESS
DPM
Label Errors
Internal Audits
Change Control

ENVIRONMENTAL
Environmental DATA
Monitoring PROJECT CAPER
OOS IMPROVEMENT CLOSED
TEAM (PIT)

SAFETY DATA
FEEDBACK
END OF ATTACHMENT I

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 ATTACHMENT II

CAPAR PROJECT MANAGEMENT FORM

DESCRIPTION:

ROOT CAUSE:

PROJECT PLAN:

TEAM MEMBERS:

MILESTONE DUE DATE ACTUAL DATE MILESTONE STATUS

RISK ASSESSMENT: (Are other similar product, processes or quality systems

affected)

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 ATTACHMENT II CONT’D

REPORTING:

MANAGEMENT REVIEW DATES MANAGEMENT REVIEW STATUS

CORRECTIVE ACTION OR JUSTIFICATION FOR NO CORRECTIVE ACTION:

IMPLEMENTATION DATE:

PREVENTIVE ACTION OR JUSTIFICATION FOR NO PREVENTIVE ACTION:

IMPLEMENTATION DATE:

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 ATTACHMENT II CONT’D

VERIFICATION/VALIDATION:

VERIFICATION DATE:

CLOSURE DATE:______________

QA APPROVAL:_______________ DATE:__________

END OF ATTACHMENT II

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