Capa Procedure
Transcript of Capa Procedure
1. PURPOSE:
To establish a procedure to correct non-conformities in Products & Processes of
the company and to take preventive actions to stop recurrence of the same.
2. SCOPE:
Applicable to non-conformities observed in company’s process & products both
before & after sale.
3. RESPONSIBILITY:
Dept. Heads & M.R.
4. REFERENCE:
ISO /TS16949:2009 – Clause 8.5.2 & 8.5.3
5. PROCEDURE:
5.1. Process & Product non conformities are reported in following ways
o Daily & Monthly Rejection & Rework Reports
o Customer Complaints.
Pareto Analysis is carried out on reports of non-conformities. High ranked
reasons for non-conformities are referred to a team representing relevant
functions. The team analysis each reasons and formulates a suitable action plan
& fix responsibilities for corrective actions. The corrective & preventive actions
are monitored periodically till completion.
5.2. Customer complaints are received by Quality Assurance Dept. Each
complaint received is referred to corrective & preventive action team. On
BINDU LABELS
PROCEDURE FOR CORRECTIVE &
PREVENTIVE ACTION
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critical non-conformances a root cause analysis is carried out. The team
analyses complaints and decides necessary time bound actions. The
decisions are recorded in 8-D Form. The Progress of corrective &
preventive actions plans are monitored by MR until effective results are
obtained.
5.3. Customer is communicated on the progress of Corrective & Preventive
Actions
5.4 Corrective & Preventive Actions are carried out on a time bound action plan.
6. RECORDS:
Sr. No.
Name of the Record Format No.
1 Rejection Report Q8300002
2 Customer Complaints Q7230001
3 Corrective Action Plans Q8520001
4 8-D Forms Q8520002
BINDU LABELS
PROCEDURE FOR CORRECTIVE & PREVENTIVE
ACTION
Doc No.: Q 85201Rev.No.0.0 Dt.: 12.06.2009Page 2 of 2