Professional Documents
Culture Documents
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.
1
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.
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.
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.
2
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.
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.
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.
3
PROCEDURE
A. OVERVIEW
4
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 Service Designated Unit
Reports in ,
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
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
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 BOP.X.MP-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 BOP.X.MP-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
C. CAPA METRICS AND TRIGGERING THRESHOLD:
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.
E. PROCESS IMPROVEMENT TEAM
G. EFFECTIVENESS:
END OF DOCUMENT
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 CONTROLS UNIT MGR
PM System
EPWO
Work Order Errors
Training
NCMR
Deviations QUALITY CAPAR MANAGEMENT ASSIGN TO IMPLEMENT MANAGEMENT
MANAGEMENT CORRECTIVE VERIFY CAPAR
Restrictions DATA INITIATED REVIEW TASK FORCE 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
ATTACHMENT II
DESCRIPTION:
ROOT CAUSE:
PROJECT PLAN:
TEAM MEMBERS:
REPORTING:
IMPLEMENTATION DATE:
IMPLEMENTATION DATE:
ATTACHMENT II CONT’D
VERIFICATION/VALIDATION:
VERIFICATION DATE:
CLOSURE DATE:______________
QA APPROVAL:_______________ DATE:__________
END OF ATTACHMENT II