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QM 9 Rev 26 Control of Non Conforming product - Uncontrolled copy

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UNCONTROLLED COPY
QUALITY MANAGEMENT PROCESS
No. QM-9; Rev.26
Page 1 of 8
Date:
20.06.2023
TITLE: CONTROL OF NON-CONFORMING PRODUCTS, COMPONENTS AND/OR ACTIVITIES
1.0
OBJECTIVE
The objective of this procedure is to prevent the product/component, and/or activities non-conformance
to specified requirements from unintended use at all stages of manufacture and to maintain the effectiveness
of the Quality Management System.
2.0
SCOPE:
This procedure describes the system to be followed for identification, evaluation, and disposition of nonconforming product/component, and/or activities observed during various stages.
This procedure also applies to all personnel with authority to review nonconformance, personnel with
authority for the disposition of nonconforming product, component, activities, and all personnel responsible
for identifying, documenting, and controlling nonconforming product, component, and/or activities
This procedure is applicable to all the following systems and standards
ISO 9001: 2015
⚫
API Spec 6D 25th Edition dated November 2021, Errata 1 dated December 2021, Errata 2 dated Apr’2022
⚫
API 600 14th Edition, May 2021
⚫
API 609 9th Edition, Apr 2021
⚫
API 603, 9th Edition, September 2018
⚫
API 594 9th Edition, February 2022
⚫
API Spec Q1 9th Edition, Errata 3 and Addendum dated June 2016 & May 2018
⚫
PED 2014/68/EU dated :15 May 2014, Regulation 2016 no.1105
⚫
ISO 19443: 2018
⚫
This procedure applies to all processes which has an influence on product/ component, and/or activities
quality.
3.0
RESPONSIBILITY
a)
b)
c)
Management Representative.
All concerned process owners.
Quality Control (QC)-Identification, recording, disposition (by authorised personnel), re-inspection
after rework/repair.
Purchase / Production-Proposal and processing of rework/repair.
Design-Evaluation of design related non-conformance.
d)
e)
4.0
REFERENCE:
QM-5
QM-6
QM-7
QM-8
5.0
IDENTIFICATION:
QAF-024 R2
Prepared by:
SRIJITH S
Approved by:
VIJAYARANGAN MI
R
UNCONTROLLED COPY
QUALITY MANAGEMENT PROCESS
No. QM-9; Rev.26
Page 2 of 8
Date:
20.06.2023
During the process of Receiving Inspection/Line Inspection/Pressure Testing, non-conforming products, /
component, and/or activities are identified as follows:
•
Red paint for rejection
•
Yellow paint for Hold
•
Blue paint for rework/repair components
•
Status card (Hold QAF-131, Rejection QAF – 132, Rework QAF – 133)
•
Bin or designated location with above color can be used to indicate applicable
rejection/rework/hold.
6.0
EVALUATION:
6.1
INTERNAL:
When materials are found to be non-conforming to the specified requirements, the following actions
can be decided: a. Segregation
b. Reject and return (e.g., casting defects)
c. Reject or scrap (e.g., Sub-contract process fault)
d. Rework or Repair
e. Release under concession
f. Re-grade for alternate application
g. Correction
h. Informing the customer
6.2
EXTERNAL:
When materials are found to be non-confirming to the specified requirements after dispatch or use
has started, the following actions can be decided: a) Reject or Scrap (Replace with new product)
b) Rework or Repair
c) Release under concession with customer acceptance
6.3
7.0
ISO 19443: 2018 REQUIREMENT:
The following also applies
a) taking actions necessary to contain the effect of the non-conformity on other processes or
products
b) Scrap
c) Information to the customer shall include those non-conformances to be reported
d) For obtaining authorization for acceptance under concession, “use-as-is” or repair justification
shall be approved by the customer
e) For ITNS items or activities, at least 1. segregation, 2. Informing the customer and 3. Taking
actions necessary to contain the effect of the non-conformity shall be developed for nonconforming outputs
PROCEDURE
7.1
SEGREGATION:
7.1.1
If non-conformance is noticed during receiving /manufacturing/ assembly/ testing/crediting
stage, the component/product/ activities /batch shall be kept under hold. Production/
activities /Purchase shall segregate and re-offer. QC shall re-inspect. Accepted
QAF-024 R2
Prepared by:
SRIJITH S
Approved by:
VIJAYARANGAN MI
UNCONTROLLED COPY
QUALITY MANAGEMENT PROCESS
No. QM-9; Rev.26
Page 3 of 8
Date:
20.06.2023
component/product/ activities /batch shall be moved to stores/assembly/testing. To
affect supplier rating Q. Notification shall be made by QC.
7.1.2
7.2
To meet urgent requirement 100% inspection may be carried out by QC based on request
from Production/Purchase/Planning department.
REJECT AND RETURN:
7.2.1
Receipt/In-process rejection:
When materials are found to be non-confirming to the specified requirements during receipt/inprocess, QC shall make Quality Notification for the supplier, for the basic raw material by exploding
the BOM. The material shall be rejected and returned to supplier. Q-notification shall be forwarded
to the supplier along with corrective action report format (QAF -150). Feedback in the form of
corrective action report is to be obtained for non-conformance by Purchase as requested by QC.
7.3
REJECT OR SCRAP:
7.3.1
Receipt/In-process Rejection:
When materials are found to be non-confirming to the specified requirements during receipt / in
process (e.g., S/C machining fault), QC shall make Rejection report and the same shall be scrapped.
7.4
REWORK or REPAIR:
a)
Non-conformance due to Supplier:
In case of “Rework/repair” due to supplier, QC shall make Q. Notification. Q-notification shall be
forwarded to the supplier along with corrective action report format (QAF -150) and feedback shall
be obtained from supplier by Purchase.
After rework/repair the same shall be offered to QC. After inspection and acceptance, QC shall close
the Q-notification.
b)
Minor Deviation:
Minor deviations (like pin holes, porosity, unwash, excessive thickness, serration damage etc.),
noticed either during receipt / in-process inspection will be accepted by respective QC section Head
or persons authorised by him after rework or use as is. The details shall be recorded in SAP R/3, GRN
/ SCN / Register (format no. QAF – 184 as attached in the Annexure 2 of this Procedure). The various
minor deviation recorded shall be determined for root cause and analysed for corrective and
preventive action once in three months.
c)
Leaked casting during Hydro Test:
For Cast Steel valves that have leaked on pressure containing zone like body /bonnet/disc/cover, the
repair decision shall be done by QC Head only after evaluation of leaked area by RT.
Based on this NDE evaluation, it shall be decided whether to weld repair or not depending on the
discontinuity. NDE 001 can be referred for evaluation. If required additional area shall be
radiographed to find out the overall soundness of the casting.
QAF-024 R2
Prepared by:
SRIJITH S
Approved by:
VIJAYARANGAN MI
UNCONTROLLED COPY
QUALITY MANAGEMENT PROCESS
No. QM-9; Rev.26
Page 4 of 8
Date:
20.06.2023
NCR shall be authorised by QC Section Head (QAF 081), if found suitable for weld repair, after
evaluation of RT and if required after gouging/grinding. After repair welding RT on the welded area
shall be carried out and if satisfactory stress relieving shall be done as applicable.
The re-worked components shall be hydro tested (cyclic hydro testing shall be carried out if required)
as a valve/component if satisfactory NCR shall be closed.
Corrective and Preventive action

Additional evaluation on different Heats shall be done on available WIP / Stock castings, in
that size /Rating / Foundry/ catalogue, in all cases of external leakage.

If the defect encountered in the leaked body/bonnet/cover is Hot tear, crack (or) shrinkage
Methoding shall be re-established, through Purchase.
The details of leaked area with sketch and RT feedback shall be sent to foundry to evaluate
the WIP casting at foundry. Purchase shall ensure that only after satisfactory evaluation by
check shots at foundry the WIP Castings/ further pouring are allowed to proceed. A written
feedback shall be obtained from foundry by Purchase for action taken by the foundry.

d)
e)
7.5
Weld repair on unwash greater than 6” (150 mm) or 25% of the disc OD whichever is higher will
be classified as major weld repair and NCR will be raised (QAF 081). The re-worked components
shall be re-inspected and if satisfactory NCR shall be closed.
NCR will be raised (QAF 081) for major weld repair (Where preparation cavity is more than 20%
the wall thickness or greater than 1” or when the extent of weld repair is more than 65 sq. cm).
The re-worked components shall be re-inspected and if satisfactory NCR shall be closed
Release under concession
The authorized personnel shall approve with proper reasoning for use in “Release under concession”
condition.
7.6
Re-grade for alternate application
The authorized personnel shall evaluate the non-conforming product, components and/or activities
and can approve its usage in alternate application.
7.7
Major Repair Welding on Pressure Containing Castings (Where customer Approval is
required):
7.7.1
8.0
Refer Annexure-A details the series of activities identified with responsibilities for
performing Major repair welding on Pressure containing component where customer
approval is required.
RELEASE OF NONCONFORMING PRODUCT, COMPONENTS AND/OR ACTIVITIES
8.1
When a non-conforming product, components and/or activities is evaluated and released under
concession that does not confirm manufacturing acceptance criteria (MAC) shall be permitted when
relevant authority and the customer have authority to release provide that
QAF-024 R2
Prepared by:
SRIJITH S
Approved by:
VIJAYARANGAN MI
UNCONTROLLED COPY
QUALITY MANAGEMENT PROCESS
No. QM-9; Rev.26
a.
b.
c.
Products, components and/or activities continue to satisfy the applicable Design
Acceptance Criteria (DAC) and/or Customer criteria; or
Violated MAC are categorized as unnecessary to satisfy the applicable DAC and/or
Customer criteria; or
The DAC are changed and the products, components and/or activities satisfy the revised
DAC and associated MAC requirements
8.2
The details of nonconformity and repairs are recorded and maintained.
8.3
The repaired or reworked product, components and/or activities is re-inspected, and records are
maintained and the same records should be a part of NCR Closure attachment.
The customers are notified in the event that product including accessories like actuators, gear units
etc.., components and/or activities not conforming to design acceptance criteria or contract
requirements has been delivered and such notification records are maintained (QAF 70A)
The customer complaints are handled by in charge commercial / in charge Quality and records are
maintained.
8.4
8.5
9.0
Page 5 of 8
Date:
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8.6
If the product, components, and/or activities is under the warranty period, based on the nature of
complaint, the course of action towards the satisfactory completion of the complaint is initiated.
8.7
The customer is informed in writing about the course of action and if required suitable person is
deputed to the customer’s site to attend the complaint.
8.8
In case the product, components and/or activities is out of warranty period, the customer is informed
in writing about the necessary repairs and charges for the repair
8.9
On confirmation, the repair is carried out to the customer’s satisfaction.
8.10
The customer’s complaint and the root cause of nonconformance is analyzed and corrective action is
taken suitably to minimize the recurrence of similar problems in the future.
8.11
The Internal Complaints are grouped together in the CFT (Cross-Functional Team) meeting for the
closure of the Nonconformance report.
DISPOSITION:
Authorized personnel for Q-Notification/NCR disposal (Applicable for Rework or Repair and Release under
concession)
For Quality-related NCR
-
Head of QC of the applicable product group; in his absence his immediate
superior and Customer (where applicable).
For Design related NCR
Head of R&D/Concerned Design Manager & Customer (where applicable)
The typical examples for Design related NCRs are as follows:
a) Strength related nonconformance
b) Wall thickness related nonconformance
Authorized personnel for Q-Notification/NCR disposal (Applicable for Re-grade for alternative applications)
Design / QA have the authority to evaluate and approve the same
10.0
RECORDING AND ANALYSIS OF NON-CONFORMING PRODUCT, COMPONENTS AND/OR ACTIVITIES
QAF-024 R2
Prepared by:
SRIJITH S
Approved by:
VIJAYARANGAN MI
UNCONTROLLED COPY
QUALITY MANAGEMENT PROCESS
No. QM-9; Rev.26
Page 6 of 8
Date:
20.06.2023
Recording and analysis of nonconforming product, components and/or activities shall be as per table.
Stage
Method of recording
Analysis and corrective and preventive action
Receiving
Q. Notification (with QAF 150)
As per QM 10
Q. Notification, NCR (QAF 081)
As per QM 10
Minor deviation register (QAF 184)
Once in three months
NCR (QAF 081)
As per QM 10
In-process
Final
11.0
RECORD:
The non-conformance report and the action taken report including concessions shall be maintained as per QM14.
ANNEXURE -1
.
ANNEXURE-A – PROCESS FLOW CHART FOR MAJOR REPAIR WELDING ON CASTING
QAF-024 R2
Prepared by:
SRIJITH S
Approved by:
VIJAYARANGAN MI
UNCONTROLLED COPY
QUALITY MANAGEMENT PROCESS
No. QM-9; Rev.26
Sl. No.
Activity
Page 7 of 8
Date:
20.06.2023
Responsibility
How
1
Identification of Pressure containing casting for Major repair
welding (Against to the SO. No./Customer reference)
QC
NCR
2
Transferring the casting stock from component stock to
Quality Stock through ERP system to hold for obtaining
customer approval. (Traceable with Heat No., MPI/DPI No., SO
No/Customer reference)
Communication to concern Contract manufacturing (CMT)
engineer with necessary back up documents for obtaining
approval from the customer
QC
Through SAP
QC
Mail / Any other
relevant mode
4
Obtaining Customer Approval to perform Major repair welding
CMT
Mail / Any other
relevant mode
5
Communication of the customer’s approval copy for performing
Major repair welding to concern QC
CMT
Mail / Any other
relevant mode
6
On receipt of approval from the customer, Issuing Quality
notification to the L&T Valves production dept. with the
reference of customer approval to perform Major repair
welding
Traceable identification (Unique number) stamping on casting
on identified location to ensure the traceability
QC
NCR
Communication
QC
Stamping
Verification/evaluation of back up quality documents like heat
treatment log, Non-destructive examination records, etc
performed after major repair welding
Transferring the casting stock from Quality stock to
component stock through ERP system.
Uploading of all back up quality documents into OMNIDOCS for
safe storage and quick retrieval by giving input of the Unique
number.
Final documents shall be submitted to the Customer /
Customer representative for review/inspection/clearance of
Stage Inspections
QC
NCR Back up
document
QC
Through SAP
QC
Q. Notification
with Back up doc.
QC
Q. Notification
with Back up doc.
3
7
8
9
10
11
Legends:
SO – Sale Order
QC- Quality Control
NCR – Non-Conformance Report
CMT – Contract manufacturing Team
MPI – Magnetic Particle Examination
DPI – Dye penetrant examination
TPI – Third Party Inspector
QAF-024 R2
Prepared by:
SRIJITH S
Approved by:
VIJAYARANGAN MI
UNCONTROLLED COPY
QUALITY MANAGEMENT PROCESS
No. QM-9; Rev.26
Page 8 of 8
Date:
20.06.2023
REVISION HISTORY
Sl.No
Rev
Date of
Clause/Para/
No
revision
Changed/Added/
Details of Change
Deleted
1
24
05.08.2022
-
-
2
25
07.04.2023
Clause 8.3/Added
The repaired or reworked product, components and/or activities of
re-inspected records should be a part of NCR Closure attachment
point added
3
26
20.06.2023
Clause 2/ Changed
CBR plant reference removed.
QAF-024 R2
Prepared by:
SRIJITH S
Approved by:
VIJAYARANGAN MI
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