Fjjkkntive Action

Galaxy Chemicals (Egypt) S.A.
Procedure for Corrective Document No. APEX/GCE/GMP/MOGP – 3.1

and Preventive Action Revision No 04
Issue Date 30.03.2023
Effective Date 05.04.2023
Date of next review 29.03.2026
Page No. 1 of 9
Operating Process : Manual of General Procedures
Title: Procedures for Corrective Action & Preventive Action.

Purpose: To detect and eliminate potential causes of non-conformance.
Scope: All customer complaints, product recall/return a n d product nonconformities
Responsibility: As per responsibility matrix shown in the corporate Quality Manual.
Procedure:
I) Corrective Actions:
1. a) Corrective actions and preventive actions are taken immediately after any nonconformity in
product/process/service/safety/quality including quality management system is noticed before, during
and after manufacturing, or on getting any customer complaint or noticed during audits including
statutory and regulatory requirements.
b) Sequence of action varies a n d decided upon nature of the nonconformity. As representative o f
variety of non-conformities, f o l l o w i n g sequence of actions are taken for a customer complaint.
2. For any customer complaint (refer manual of procedures for customer - related processes of
Business creation process -India & International) following sequence or any of the required
investigations are carried out:
 Study of variation in our QA analysis report vis -à-vis customer’s QA report and specs including re-
analysis of control sample of finished product kept in QA laboratory.
 Type of analytical methods followed by our QA lab and our customer including testing facilities, lab
testing conditions, reagents and other parameters.
 Production Batch / Lot card is examined including QA record to know if right procedure as per
customer spec. was followed during manufacturing.
 It is checked if WM dispatched goods as per the grade mentioned in the SOC/OIN.
 Whether ILE mentioned the required grade in the SOC/OIN.
 Whether description of label / stencil matches with the material filled inside the packing.
 Whether any mix up occurred at the time of loading or at the transporters’ end during transit / or at
destination warehouse including wrong delivery by the transporters due to mix up of two different
products, removal of label / smudging of stencil in transit.
 It is checked if any non-conforming p r o d u c t (awaiting disposal) was transferred to Warehouse.
 Whether any unapproved m a t e r i a l was taken, by mistake, for production.
 All the manufacturing facilities / equipment, QA instruments working / calibration are in order
including measuring / weighing equipment / instruments.
 All work instructions, process controls and approved concessions (if any) are analyzed
including storage conditions at different stages.
GMP/MOGPMANUAL/30.03.2023 Rev04 Approver’s signature not required unless the document is printed
Copy No.:
Galaxy Chemicals (Egypt) S.A.E

Page No. 2 of 9
3. Statistical data / information gathered if requires during above steps is recorded and circulated to the
related persons.
4. Other relevant c o r r e c t i v e actions are identified / recorded by concerned Process Head /

Process Leader / Section in-charge and reviewed d u r i n g monthly or MRC meetings whenever
required.
II) Preventive Actions:

1. Pro-active preventive a c t i o n s as well as after any post-manufacturing n o n -conformance
i n c l u d i n g customer complaints are taken.
2. Wherever required, P r o c e s s Heads or Process Leaders have included preventive a c t i o n

procedure in their departmental manual.
3. After every quality system audit, Process Heads or Process Leaders r e v i e w the non-conformities
with his team members and take the corrective action and implements the required preventive
actions.
4. M.R. compiles the corrective action and preventive a c t i o n plans of various f u n c t i o n s and
presents a consolidate status to MRC. During follow up audits, auditors verify the implementation
& effectiveness o f the corrective actions as well as preventive a c t i o n s taken for the previous n o n -
Conformities.
5. Preventive actions taken in advance are shown in the following Preventive Action Control Chart:
Note: Any change while implementing corrective and/or preventive actions or

improvement themes are considered as change and procedure for management of
change is strictly followed.
Copy No.:

Page No. 3 of 9
Preventive A c t i o n Control C h a r t
Customer requirements & No BC / DLE / ILE CS/resolves first with

specifications the customer
Yes
BC / DLE / ILE immediately BC / DLE / ILE/CS members

No explains delay in SOC preparation
prepares SOC & forwards to factory
Yes
No FGDS returns the SOC to BC / DLE
Factory warehouse team checks if / ILE/CS members for correction &
SOC is complete in all respects. completion
Yes
Warehouse team takes
No Warehouse team explains delay in
acknowledge from production in-
charge on duplicate copy of SOC & acknowledgment
forwards to BC / DLE / ILE/CS
members.
Yes
PI plans production, checks Production in-charge or QA
availability of approved RM. No in-charge or Leader- CP
Mfg.
explains delays in their respective
areas
Yes
Batch is made as per the approved No Batch is not charged; QA stops the
process: in-process QA checks,
production.
maintenance of equipment under
defined conditions.
Copy No.:

Page No. 4 of 9
preventive action control chart (Continue…)
Yes
All production parameters & QA QA Lab. stops production &

instructions are followed, (industrial No refuses release of QA report
Defined calibration) entry in batch /
lot card
Yes
Any non-conformance QA fills non-conformity report &

takes further corrective action
Yes
including disposal
No
Material is filled in containers;

QA stops loading /removal of
accurate weighing; transfer to FG No goods from factory.
Warehouse after labelling along
with QA report.
Yes
Warehouse team organizes dispatch

QA stops transfer to Warehouse;
as per priority / schedule matching No Warehouse team returns Goods to
SOC details; goods to leave with QA
Production & informs to BC/DLE/ILE
report & proper documentation.
members
Yes
Warehouse Team informs /
forwards dispatch details / No BC/DLE/ILE members, takes up
documents to customer / with production in-charge and
BC/DLE/ILE members circulates summary in monthly
Yes
Above steps are followed in future.
Any customer complaint
(BC/DLE/ILE members, fills
No
complaint monitoring data &
forwards to QA)
Copy No.:

Page No. 5 of 9
Preventive Action Control Chart (Continue…)
Yes
No prevention of recurrence of the
QA investigates as per sequence
problem.
under corrective actions,
No
Investigation format is filled to find
out root cause
Yes
Communicates to the customer
QA identifies the reasons & record No
through BC/DLE/ILE members
them
Yes
Investigation continues People need training; MRC

No reviews the problem
Yes
Is solution arrived for the problem? MRC monitors progress

No
Yes
1. MRC keeps a track.
BC / DLE / ILE members seek No 2. Internal audit verifies complaint
satisfaction report fro customer; monitoring till the stage of
recurrence is prevented through completion
reviewing / sharing / training 3. Process Head remains vigilant
Copy No.:

Page No. 6 of 9
6. Trends of quality records are analyzed for determination of frequency of preventive a c t i o n analysis.
7. i)Finished product nonconformities are identified by QA and NCP report is prepared stating the type
of non-conformity and distributed to concerned departments with the disposition suggestions as
given in QA manual. QA and Production department jointly review a n d analyze the non-
conformances causes of the products with the help of statistical tools. Corrective actions suggested
by review committee and authorized by Q A in-charge, is distributed to production and
DLE/Warehouse Management for implementation in their areas.
If corrective action suggested is ineffective, t h e details of non-conformance a r e brought to the
attention of R&D and their analysis of problem to identify the root cause is incorporated in process
work instructions/ specifications as per procedures f o r document and data control.
ii) Non-conformances w . r . t . raw material supplied by the vendor, a re monitored by QA and the quality
report forms the basis for further evaluation o f vendor. If need arises, vendor audit is performed by QA
and purchase and; the deficiencies in the quality system at the vendor are reported who is advised to
take the corrective action and preventive action.
iii) The procedure for corrective actions of in-process non-conformance is similar to finished product
non-conformance. Process parameters like in-process analysis data are monitored as preventive
measure to have a check on the final product quality.
8 QA records the corrective and preventive actions in the format defined in section 3.1.
9 This procedure is also followed for safety related observations, Possible environmental incidences,
deviations observed in the systems and all related areas where there is impact on QMS and EMS.
Handling of Internal Customer Complaints

 There are situations when functioning of a process, either comes to a standstill or efficiency reduces
including affecting their own commitments, due to poor or delayed service by supplier dept.
Sometimes this affects the quality management system adversely including tarnishing organization’s
image in the eyes of an external customer.
 All departments raise such issues in writing by filling the ‘Internal Customer Complaint Monitoring
Sheet’ whenever quality of service is poor in the following areas :
 All the areas affecting our meeting the quality objectives and quality management system.
Copy No.:

Page No. 7 of 9
 All internal complaints are resolved by members only. Complex situations are resolved by Process
Heads or Process Leaders. Complaints having global impact are referred to Directors for their
support.
 Concerned Process / Sub-process who lodges the complaint, incorporates summary of all the
unresolved complaints in their monthly MIS.
 Process Head / Process Leaders getting the complaint, fills the steps initiated by him/ his team in
corrective action & preventive action format (as defined in Section 3.1) and forwards a copy to the
Process Head / Process Leaders or person raising the complaint. Record is retained for 3 years.
 Complaint can be raised by any member of the department but before submitting, it is approved by
Process Head / Process Leaders.
Format for Internal Customer Complaint Monitoring (GCE-GSL):
INTERNAL CUSTOMER COMPLAINT MONITORING

Sr.
Particulars / Details Actual Data
No.
1 Complaint No./ Date
Internal customer raised by –

2
Process / Sub-process
Internal supplier against which complaint is being

3
raised
4 Nature of complaint
Was similar complaint raised earlier Y es / No.
If y es -
5
a) When
b) What correctiv e actions were taken
Ef f ect of complaint on
a) QMS
6
b) Cost
c) Ef f ect on serv ice to external customer
7 Suggestions – how the repetition can be av oided
8 Any management support required
9 Other inf ormation
Complained Raised by - Name:

10
Sign:
GMP/ MOGPMANUAL/01.04.2020 Rev03 Approver’s signature not required unless the document is p rinted
Copy No.:

Page No. 8 of 9
Approv ed by - Name:
11
Sign:
FMT/QMS/006/Rev-0 30/09/2011
Distributions:
1. Directors
2. MRs.
3. Process Heads
4. All Related – Process Leaders / Sr. Associates/ Associates
Copy No.:

Page No. 9 of 9
Sr.
Revision No. Date of issue Reason for change
No.
1 0 01.08.2012 Original issue of Document
2 1 01.04.2015 All the documents revised in line with global change of

documentation system.
3 2 01.04.2018 Entire manual revised as per ISO 9001 :2015

requirements.
4 3 01.04.2020 Entire manual released as per ISO 22716 :2007

requirements.
5 4 30.03.2023
Entire manual issued as per EFfCI GMP requirements
Owned by Approved by Issued By
Leader-Quality Process Head-Quality Process / Managing Director Management Representative
Copy No.:

Fjjkkntive Action

Uploaded by

Document Information

Original Description:

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Fjjkkntive Action

Uploaded by

Copyright:

Available Formats

Galaxy Chemicals (Egypt) S.A.

Procedure for Corrective Document No. APEX/GCE/GMP/MOGP – 3.1

Title: Procedures for Corrective Action & Preventive Action.

Scope: All customer complaints, product recall/return a n d product nonconformities

Responsibility: As per responsibility matrix shown in the corporate Quality Manual.

Procedure for Corrective Document No. APEX/GCE/GMP/MOGP – 3.1

4. Other relevant c o r r e c t i v e actions are identified / recorded by concerned Process Head /

II) Preventive Actions:

2. Wherever required, P r o c e s s Heads or Process Leaders have included preventive a c t i o n

Note: Any change while implementing corrective and/or preventive actions or

Procedure for Corrective Document No. APEX/GCE/GMP/MOGP – 3.1

Customer requirements & No BC / DLE / ILE CS/resolves first with

BC / DLE / ILE immediately BC / DLE / ILE/CS members

Procedure for Corrective Document No. APEX/GCE/GMP/MOGP – 3.1

preventive action control chart (Continue…)

All production parameters & QA QA Lab. stops production &

Any non-conformance QA fills non-conformity report &

Material is filled in containers;

Warehouse team organizes dispatch

Procedure for Corrective Document No. APEX/GCE/GMP/MOGP – 3.1

Preventive Action Control Chart (Continue…)

Investigation continues People need training; MRC

Is solution arrived for the problem? MRC monitors progress

Procedure for Corrective Document No. APEX/GCE/GMP/MOGP – 3.1

Handling of Internal Customer Complaints

Procedure for Corrective Document No. APEX/GCE/GMP/MOGP – 3.1

INTERNAL CUSTOMER COMPLAINT MONITORING

1 Complaint No./ Date

Internal customer raised by –

Internal supplier against which complaint is being

Was similar complaint raised earlier Y es / No.

b) What correctiv e actions were taken

c) Ef f ect on serv ice to external customer

7 Suggestions – how the repetition can be av oided

8 Any management support required

9 Other inf ormation

Complained Raised by - Name:

Procedure for Corrective Document No. APEX/GCE/GMP/MOGP – 3.1

Procedure for Corrective Document No. APEX/GCE/GMP/MOGP – 3.1

1 0 01.08.2012 Original issue of Document

2 1 01.04.2015 All the documents revised in line with global change of

3 2 01.04.2018 Entire manual revised as per ISO 9001 :2015

4 3 01.04.2020 Entire manual released as per ISO 22716 :2007

Owned by Approved by Issued By

Leader-Quality Process Head-Quality Process / Managing Director Management Representative

You might also like