QUALITY MANAGEMENT SYSTEM PROCEDURE Doc. No.

: QSP-24
KEIL ABNORMALITY HANDLING
Doc. Date: 01/09/2017
Rev. No.: 02
Rev. Date: 04/11/2019
Page: - 1 of 4

1. OBJECTIVE: - A - To analysis abnormality condition.

B - To cater plant requirement under abnormal condition.

2. SCOPE: - The activities specified under abnormality situations are applicable for all the product
manufacturing process

3. PROCESS OWNER: - Quality Assurance Head

4. IMPORTANT DEFINITIONS: -

 Abnormal Condition – An abnormal condition/Change is a disturbance or series of disturbances in a Process

that cause plant operations to deviate from their established Standards or Normal operating State.
 Retroactive Check: It is the checking of products up to defect generated from prior OK Inspection
Inspection Criteria - check 5 Pieces (approx.1 Meter each) dimensionally and 100% visually per coil
 Suspected Lot: - It is the lot of products being produced in case of Abnormal Change.
Inspection Criteria – check 6 Pieces (approx. 1 Meter each) dimensionally and 100% visually per coil
 Containment Action: containment action is to be taken to define the root cause and permanent corrective
action for the abnormal change.

5. DESCRIPTION: -

Sr.No Activity Resp Reference

.
Operator of under skill deputed: -
 Perform set Up Approval. Quality
5.1
 Segregate the products produced by this operator. Inspector QA-F-01
 Inspector shall check the Products as per Suspected lot
Check criteria.
Operator suddenly leave work place due to accident/illness: -
 Perform set Up Approval. Quality
5.2
 Segregate the products produced by this operator. Inspector QA-F-01
 Inspector shall check the Products as per Retroactive
Check criteria.

Prepared By: - Sagar Daund Approved By: - Pradeep Navale

 QUALITY MANAGEMENT SYSTEM PROCEDURE Doc. No.: QSP-24
KEIL ABNORMALITY HANDLING
Doc. Date: 01/09/2017
Rev. No.: 02
Rev. Date: 04/11/2019
Page: - 2 of 4

In Case of Shift Extended (either Full time or few hours) Quality

5.3  Operator shall inform to Production Supervisor and then Inspector QA-F-01
Quality Inspector
 Update the status of 4M change
 Make Set-Up Approval before starting Production.
 Hold Products Produced in this Time Period.
 Inspect the Products as per Criteria to check Suspected Lot
as defined in 4M Change Management Procedure.
 Quality Inspector shall take approval on Inspection Results
from QA Engineer
Due to Breakdown, Shift of production to low capacity machine: -
 Perform set Up Approval. Production
5.4
 Segregate the products produced by this operator. Engineer QA-F-01
 Inspector shall check the Products as per Suspected lot
Check criteria.
Continuous production of 5 defective coils: -
 Operator shall Stop the Machine. Quality
5.5
 Perform set Up Approval. Inspector QA-F-01
 Inspector shall Check Products according to Retroactive
check method.
POKA Yoke Failure: -
 Perform set Up Approval. Quality
5.6
 Segregate the products produced on this machine. Inspector QA-F-01
 Inspector shall check the Products as per Suspected lot
Check criteria
POKA Yoke Removal: -
 Perform set Up Approval. Quality
5.7
 Segregate the products produced on this machine. Inspector QA-F-01
 Inspector shall check the Products as per Suspected lot
Check criteria
Change in material Grade/Chemical composition: -
 Perform set Up Approval. Quality
5.8
 Segregate the products produced from this raw material. Inspector QA-F-01
 Inspector shall check the Products as per Suspected lot
Check criteria.

Prepared By: - Sagar Daund Approved By: - Pradeep Navale

 QUALITY MANAGEMENT SYSTEM PROCEDURE Doc. No.: QSP-24
KEIL ABNORMALITY HANDLING
Doc. Date: 01/09/2017
Rev. No.: 02
Rev. Date: 04/11/2019
Page: - 3 of 4

Material received from Non-approved supplier: -

 Perform set Up Approval. Quality
5.9
 Segregate the products produced from this raw material Inspector QA-F-01
 Inspector shall check the Products as per Suspected lot
Check criteria.
Material received from approved supplier after long time: - Quality Inspector

 Perform set Up Approval.

 Segregate the products produced from this raw material. Quality QA-F-01
5.10
 Inspector shall check the Products as per Suspected lot Inspector
Check criteria.
Error in measuring instrument after start of production
 Segregate the products checked by this Instrument from Quality
5.11
expiry date. Engineer PRD-F-02
 Inspector shall check the products as per Retroactive check
criteria
Measuring instrument Out of Calibration: -
 Segregate the products checked by this Instrument from Quality
5.12
expiry date. Engineer PRD–F-01
 Inspector shall check the products as per Retroactive check
criteria.
Instrument got damaged / Fallen down: -
 inform to supervisor and validate the instrument or else Quality
5.13
send for calibration. Engineer PRD–F-01
 Use another Calibrated instrument for further use.
Coil /Spool Fallen down: -
 Segregate the coil. Quality
5.14
 Inspector shall check the Products as per Suspected lot Inspector PRD-F-17
Check criteria.
Process Sequence change: -
 Perform set Up Approval. Production
5.15
 Segregate the products produced. Engineer QA-F-01
 Inspector shall check the Products as per Suspected lot
Check criteria.
If Inspector Failed in poison test –
 Retrain Inspector for Visual Inspection Quality
5.16
 Segregate the products checked by this Inspector. Engineer
 QA Engineer shall check the products as per Retroactive
check criteria.

Prepared By: - Sagar Daund Approved By: - Pradeep Navale

 QUALITY MANAGEMENT SYSTEM PROCEDURE Doc. No.: QSP-24
KEIL ABNORMALITY HANDLING
Doc. Date: 01/09/2017
Rev. No.: 02
Rev. Date: 04/11/2019
Page: - 4 of 4

6. Documents: -

Sr No. Doc. Name Doc. Date Doc. No.

1 4M Change Management 01/09/2017 QSP-22

2 Breakdown and Preventive Maintenance 01/09/2017 QSP-05

7. Records: -

Sr. No. Name Format No. Retention Period Doc. Date

1 Set-Up Approval report QA-F-01 03 Years 01/09/2017

2 4M Change Summary Sheet PRD-F-01 11 Years 01/09/2017

3 Suspected Lot Inspection PRD-F-17 11 Years 01/04/2019

4. Retroactive Check PRD–F-02 11 Years 01/09/2017

Prepared By: - Sagar Daund Approved By: - Pradeep Navale