CAPA implementation form Format | Example | Samples | Excel File | Word Document

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CAPA Implementation Flow

• Deployment Flow of CAPA
• Receipt Inspection Non Conformities
• Data Collected by QC on monthly Basis (Rejection, Rework)

  >> Sub Contractor Ref. Analysis

• Monthly analysis Reviewed by team
• Initiate CAPA for Repeated and Major NC

  << Monthly analysis Reviewed by QA / Production

  << In process / Final Inspection Non conformities

• Prepare CAPA Report
• Analyze root cause
• Identify Solution & Time frame as appropriate
• Implement solutions
• Monitor effectiveness monthly CAPA Review IN GDP
• Are Actions effective? if, yes close the CAPA

Implementation Phase:

Corrective action

Corrective and Preventive action shall be initiated for Incoming rejection, in process nonconformance, in process rejection / rework, customer complaints, Warranty claims.

For Incoming Rejection Quality. records the details of nonconformance in subcontractor nonconformance analysis report and prepares the summary at the end of every month. Appropriate corrective actions shall be initiated on the basis of nature of nonconformance by subcontractor in consultation with Head Materials. Same will be reviewed every month by Head Materials

For in process non-conformances, Q.C. records the same in In-process non-conformance report, shop floor audit reports, Patrol inspection report & prepares the summary at the end of every month. In process rejection & rework data and in process non conformances will be reviewed between Head Q.A., Head Production, & Head Process and appropriate corrective and Preventive action shall be initiated in monthly review meeting coordinated by Head Process. The appropriate corrective and Preventive action shall be initiated as per the target dates finalized in the meetings.

For customer complaint, Physical receipt from customer, actions shall be initiated as per procedure for customer complaint handling, which shall be reviewed once in a month in GDP meeting actions shall be initiated.

For Internal Quality Audit, appropriate corrective actions shall be initiated within 2 weeks by concerned department heads. Effectiveness and impact of Corrective and Preventive action shall be reviewed monthly between Respective HODs, MD and GM (Operations.). This meeting will be coordinated by Asst. Mgr. marketing and communication.

The agenda for Corrective and Preventive action shall be circulated to all concerned members one week prior to the scheduled meeting. The actions initiated in the meeting shall be circulated to all concerned members within one week of the meeting. Status of pending Corrective and Preventive action shall be reviewed in all the monthly Corrective and Preventive action meetings.

Preventive action:

Feedback from processes and work operations, analysis of system records, concessions applied to processes or product, audit results, service reports and market feedback are used as sources of information to detect, analyze and eliminate potential causes of nonconformity and occurrence of nonconformity.

Changes to the system, in order to prevent occurrence of nonconformity, due to statutory and regulatory requirements or due to changes in procedures are reviewed by MD / MR and implemented by respective departments.

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