QSP 07 CAPA Rev 1

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SPI/QSP/07/CAPA

QUALITY SYSTEM PROCEDURE Issue: C


Rev. No: 01
Date: 01.11.2020
CORRECTIVE ACTION & PREVENTIVE ACTION
Page 1 of 4

.1.0 Purpose
To ensure that the product which does not conform to product requirements is identified &
controlled to prevent its un-intended use or delivery.
1.1 Application
This procedure is applicable for all the activities covered under QMS at SRI PANDIYAN INDUSTRIES
1.2 Responsibility
All process owners are responsible to ensure that timely action is taken to eliminate the causes of
nonconformities thereby improve the performance of the process.
1.3 Terms and definitions
Corrective Action – Action to eliminate the cause (s) of a detected nonconformity or other
undesirable situation.
Correction – Action to eliminate a detected nonconformity.
Defect – Non-fulfillment of a requirement related to an intended or specified use.
Nonconformity: Non-fulfillment of a requirement
Preventive action – Action to eliminate the cause (s) of a potential nonconformity or other
undesirable potential situation

CPAR – Corrective and Preventive action report

2.0 Procedures
2.1 Corrective action

Corrective and Preventive action sources are designated below. Management Representative can
request corrective or preventive actions apart from these issues, if required or top most in-house
rejection

2.1.1 Need for corrective action arises when nonconformity is identified in


 Product,
 Process, and
 Systems.
2.1.2 Nonconformity in product, process and systems may get identified during;
 Inspection & testing,
 Process performance results
 Internal audits,
 External audits, and
 Through customer complaints and customer feedback.

2.2. Management Meetings:

Measurable Objectives are reviewed by the PROPRIETOR in Management Review Meetings. Review
Meetings Details are given in the Meeting Management Review Procedure. QMS-Cooradiator can

SRI PANDIYAN INDUSTRIES


SPI/QSP/07/CAPA
QUALITY SYSTEM PROCEDURE Issue: C
Rev. No: 01
Date: 01.11.2020
CORRECTIVE ACTION & PREVENTIVE ACTION
Page 2 of 4

request necessary corrective and preventive action from related personnel according to results of
the Management Review.

2.3. Internal Quality Audits:

All details about internal audits and the following corrective and preventive action
implementation are described in the Internal Quality Audits procedure.

2.4. Customer Complaints and feedback:

Customer complaint is recorded in complaint register by Manager-Quality. The reason for


complaint is discussed with respective department person and root cause is arrived at. After root
cause analysis, necessary corrective action will be arrived at and recorded in complaint record.

2.5. Suppliers’ and subcontractors’ Processes:

Supplier rating will be carried out every 6 months. In case any of the suppliers scores less than
70% suitable corrective action will be asked for from the respective supplier. If the supplier
scores less than 70% continuously two times, they will be de-listed from the approved list.

2.6. Customer inspection:

In case of any non conformity or complaint is observed during customer inspection, the problem is
rectified immediately and suitable corrective action will be taken. The details will be recorded in
Customer complaint register.

2.7. Closing Corrective and Preventive Actions:

Corrective and preventive actions are closed by the responsible person by filling the necessary
place in the CPAR. Closed Corrective and Preventive Actions Form is given to the MR for records.

3.0. Following up of Corrective and Preventive Actions:

Functional head follows up the closing of the Corrective and Preventive Actions on the defined
deadline time. Follow up notes are written on Corrective and Preventive Actions Form by
respective functional head. Following up Date is recorded in Corrective and Preventive Actions
report. This can be done either through brainstorming or through using Cause & Effect Diagram.
More importance and stress to be given to analysis of various checks & controls adapted in the
system for their effectiveness.

4.0. Verification of the Corrective and Preventive Actions:

Corrective and preventive actions are verified by the Proprietor in related place. If required, new
corrective and preventive actions are requested by the QMS-Co Ordinator.

SRI PANDIYAN INDUSTRIES


SPI/QSP/07/CAPA
QUALITY SYSTEM PROCEDURE Issue: C
Rev. No: 01
Date: 01.11.2020
CORRECTIVE ACTION & PREVENTIVE ACTION
Page 3 of 4

The IATF Audits Nonconformities raised by the certification body should discussed in the
Management review meeting and to be verified for the corrective action Checked in the each
Internal Audit.

This is responsibility of the QMS-Co Ordinator and respective Process audits(Linked to Internal
audit procedure SPI/QSP/05/IQA)

5.0. Reporting Corrective and Preventive Actions:

QMS-Co Ordinator prepares a report about corrective and preventive actions to discuss the results
in Management Review Meeting. Closed, verified, not verified, open corrective actions are
reviewed in these meetings and an action plan is defined.

6.0. Selection of Process for Error Proofing:

Use Cross functional teams (CFT) approach to mistake proofing. Analysis of customer complaints
also reveals activities which are in need of mistake proofing, in order to achieve the zero defect
level of working. CFT will undertake the application of poka-yoke techniques to these processes

During the third phase of Advanced Product Quality Planning (APQP), the CFT shall identify the
processes, where, due to avoidable human errors, the rating of “occurrence” and/or “detection”
has increased thereby increasing the risk priority number (RPN) for the process. Poka-Yoke
techniques in order to lower the ratings of occurrence and /or detection

The selected mistake proofing techniques should qualify the following criteria:

o Inexpensive

o Based upon common sense, preferably of the operator

o It Must eliminate occurrence/detection on the problem at the source itself

7.0 Associated Documents and Records


Sl. Authorizing Custodian of Retention
Name of the Record
No Personnel record Time
Concerned
Corrective action & Preventive Concerned
1 functional Head 3 years
action report functional Head
/ QA Head

8.0 Reference
a) IATF 16949: 2016 Clause Number 6.1.2.1, 6.1.2.2 & 10.2

9.0 Associated Documents

SRI PANDIYAN INDUSTRIES


SPI/QSP/07/CAPA
QUALITY SYSTEM PROCEDURE Issue: C
Rev. No: 01
Date: 01.11.2020
CORRECTIVE ACTION & PREVENTIVE ACTION
Page 4 of 4

1) Procedure for Control of Records


2) Procedure for Internal audit
3) Procedure for Control of NC Products

10.0 Changes

Required changes of this Procedure have to be directed in writing to the team leader of
this Procedure. Such change requests will be discussed within the team and in case of
improvement implemented into the Procedure. The changes have to be described in the
revision sheet. Responsible for documentation and change of the Procedure on the sheet
“Revision” is the team leader.

11.0 Distribution

After release by the QMS-Co Ordinator this Quality System Procedure will be released with
controlled copy to related department as per the distribution list of documents by QMS-
Coordinator.

12.0 Revisions
Sl:
Revision Date Description of change
No
1 C/00 01.12.2018 New Release
IATF Audit Nc Corrective Action Description
2 C/01 01.11.2020
Page No 2 of 4. Section 4.0

Revisions authorized by:

Prepared: _____________________________ _______________________________________________________________________________________________________________

Date QMS CO-ORDINATOR

Approved: ___________________________ _______________________________________________________________________________________________________________

Date PROPRIETOR

SRI PANDIYAN INDUSTRIES

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