NONCONFORMING MATERIAL CONTROL & REVIEW
1.0
2.0
PURPOSE AND SCOPE
1.1
To establish the requirements for the control and disposition of nonconforming Product.
1.2
This procedure applies to nonconforming product found in incoming
inspection, WIP, finished products, in service, customer sites, and
customer returned products.
DEFINITIONS
2.1
Advisory notice: A notice issued upon detection of nonconforming
material/ product after delivery or use by end Customer has started. It
includes the relevant information regarding the effects or potential
effects of the nonconformity.
2.2
Customer: Company or organization that has contracted services of
XXXX Medical Division to manufacture product per specifications
defined by customer.
2.3
Customer Concession: The authorization by customer to use or
release product that does not conform to specified requirements.
2.4
Deviation: Authorization for use or acceptance of product that does not
conform to drawing or specification.
2.5
Material Review Board (MRB): Consists of members from Quality
Assurance, Manufacturing Engineering, Purchasing and customer
when signature approval is required on an NCMR to authorize
disposition of the product or to approve the request for variance, and
the assignment of corrective action responsibility).
2.6
MRB Coordinator: Designated representative from Quality will manage
MRB program and chair MRB meeting.
2.7
Nonconforming Product:
specifications.
2.8
Nonconforming Material Report (NCMR): The document used in
recording the occurrence of a nonconformance or to request a
specification variance (SV), the disposition of that product or request,
and initiate the requirement for corrective action, as required.
2.9
Nonconforming Material Disposition:
The conclusion reached after
reviewing and considering all aspects of the nonconformance. The
Any product that does not meet specified
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NONCONFORMING MATERIAL CONTROL & REVIEW
conclusion results in a decision to use as is, sort, rework, repair scrap,
return to vendor, or deviate.
2.9.1 Use as is: Product that has been verified not to cause
nonconformance of the top assembly to issued specifications.
2.9.2 Return to Vendor (RTV): Product that has been rejected and is to
be returned to the source for credit, replacement, rework, or
sorting.
2.9.3 Sort: Separation of conforming from nonconforming Product:.
2.9.4 Rework: means action taken on a nonconforming product so that
it will fulfill the specified DMR requirements before it is released
for distribution. An example of rework would be taking a down
revision product that must be upgraded to match current
specifications. Generally, routine reconditioning or repair prior to
distribution is not considered reworking unless the activity would
adversely affect the reliability, safety, or effectiveness of the
device.
2.9.5 Repair: Action on a nonconforming product to make it acceptable
for intended use. Repair includes remedial action taken on a
previously conforming product to restore it for use, for example as
part of maintenance. Unlike rework, repair can affect or change
parts of the nonconforming product.
2.9.6 Scrap: Nonconforming product that cannot be processed for
technical, safety, or economic reasons and is to be destroyed or
otherwise removed from the manufacturing system.
2.9.7 Deviate: Allows acceptance of a product to authorized
specifications that are different from issued specifications.
3.0
2.10
Product: means components, manufacturing materials, in- process
devices, finished devices, and returned devices.
2.11
Specification: Any requirement with which a product, process, service,
or other activity must conform.
2.12
Supplier: Provider of any product used or consulting services provided
for manufacture of XXXX Medical products.
GENERAL
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NONCONFORMING MATERIAL CONTROL & REVIEW
3.1
This procedure is used in conjunction with SOP-3-MD8000-A Corrective
and Preventive Action procedure for Internal or Supplier corrective
actions pertaining to nonconforming product.
3.1.1 Customer complaints related to nonconforming devices are
handled according to Complaint Handling and Reporting
procedure, SOP-3-MD8002-A.
3.2
Product with unidentified or suspect status shall be classified as
nonconforming product.
3.2.1 Non-conforming product shall be segregated immediately from
production. If product is moved from the production floor to a
segregated staging area for MRB disposition, then this product
must be transferred to MRB within 24 hours, both physically and
electronically in Oracle. No disposition shall be performed until
completing the transfer to MRB and NCMR form is initiated.
1
3.3
If the product cannot physically fit in defined MRB area, then this
product shall be moved away from the regular production area,
segregated, and clearly identified as non-conforming.
3.4
Identified product nonconformance shall be documented for evaluation
and investigation result (if applicable) by using a Non-Conforming
Material Report (NCMR). The nonconformance should be quantified by
defect type, identified, and segregated for proper disposition. The
description of nonconformance should be in specific terms, not
generalities that don’t adequately describe the nonconformance.
3.5
The evaluation of nonconformance shall include a notification of the
persons or functions directly responsible for the nonconformance and/or
assuring the quality of such product and the determination of the need
for an investigation and/or a CAPA. The aim is to prevent further
reoccurrence of the problem.
3.6
When nonconforming product is dispositioned as Use-As-Is (UAI), a
justification of use and the signature of the individual(s) authorizing the
use shall be documented in the MRB record1.
3.7
When nonconforming product is dispositioned as rework to be
performed internally by XXXX or via an outside supplier, rework
instructions shall be attached to the NCMR and approved by the
customer.
Use log, minutes, or terminology that is consistent with existing Sanmina procedures.
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NONCONFORMING MATERIAL CONTROL & REVIEW
3.8
The function responsible for coordinating the nonconforming product
disposition process shall ensure that an NCMR is completed in
accordance with this procedure.
3.9
Nonconforming product pending disposition shall be segregated or
clearly identified as nonconforming product in order to prevent
unintended use.
3.10
Material Purge shall be conducted according to SOP-3-MD7012-A.
Records related to product purge shall be attached with the NonConforming Material Report, SOP-4-MD7045-A.
3.11
The Material Review Board (MRB) is responsible for the review and
disposition of nonconforming products. Authorized signatures are to be
compatible with the department organization but shall include a
minimum of two functional disciplines of which one shall be from Quality
Assurance.
3.11.1 MRB can assign a disposition of “Use-As-Is” if use of
nonconforming product will NOT adversely affect part, system or
product
performance,
safety,
reliability,
appearance,
manufacturing processes, or any other quality, performance or
cost requirement known to MRB members. The justification of
“Use-As-Is” shall be documented with documented customer
approval.
3.12
When an agreement cannot be reached concerning the disposition of
nonconforming product, involved members of the MRB must escalate
the problem progressively to the next higher level of management until
the issue is resolved.
3.13
Nonconforming product shall be handled according to SOP-3-MD7023A, Handling, Storage, Packaging, Preservation, and Delivery.
3.14
When returning/shipping nonconforming product to suppliers or for
failure analysis it shall be packaged in its original packaging (if available)
or in a compatible packaging to prevent damage or deterioration.
3.15
When nonconforming product is detected after delivery or use has
started by end user, XXXX shall notify and work with Customer (OEM)
who is responsible to take appropriate action such as issuing advisory
notice to end user appropriate to the effects, or potential effects, of the
nonconformity. Records of action taken shall be maintained. Reference
SOP-3-MD8009-A Medical Device Reporting (MDR) SOP for details.
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NONCONFORMING MATERIAL CONTROL & REVIEW
4.0
3.16
Trend Analysis of discrepancies found in nonconforming product shall
be performed and reported on a monthly and quarterly basis.
3.17
When automated data processing system is used in the management
and control of the nonconforming product, it shall be validated.
RESPONSIBILITIES
4.1
VP of RA & QA, Medical Division or designee is responsible for
maintaining and revising this document.
4.2
Department Manager(s) or Supervisor(s) are responsible for:
4.2.1 Ensuring that personnel are trained and certified to all aspects
of this document and this procedure is followed.
4.3
Facility Quality Manager or designee is responsible for:
4.3.1 Ensuring that identified nonconforming product is properly
documented, labeled, or segregated pending review by the
Material Review Board.
4.3.2 Ensuring timely disposition of nonconforming product.
4.3.3 Ensuring that scrapped product is properly disposed. Finished
devices or working electronic sub-assemblies are to be made
inoperable as well as in a state that cannot be made operable
and the Device Label MUST ALSO BE REMOVED prior to
sending outside XXXX for disposal.
4.3.4 Acting as or appointing a Material Review Board coordinator.
4.3.5 Ensuring customer complaints are handled in a timely manner.
4.3.6 Ensuring CAPAs or investigations are initiated where appropriate
from the review of nonconforming product.
4.3.7 Conducting a trend analysis on discrepancies found in
nonconforming product and utilizing the analysis as input for
Corrective & Preventive Action.
4.3.8 Reviewing and approving NCMR’s with “Use-As-Is” depositions to
ensure product has been properly qualified.
4.4
Quality Inspectors, Test Technicians, or trained individuals are
responsible for:
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NONCONFORMING MATERIAL CONTROL & REVIEW
4.4.1 Documenting identified nonconformance, quality, or technical
problem in local electronic NCMR database system, or by using
Nonconforming Material Report SOP-4-MD7045-A.
4.4.2 Labeling or
disposition.
segregating
nonconforming
product
pending
4.4.3 Re-inspecting and/or re-testing reworked and repaired product to
specified inspection criteria or test plans.
4.4.4 Documenting results of inspection after rework or repair.
4.5
Material Review Board, under the guidance of the Facility Quality
Manager or designated chairperson, is responsible for:
4.5.1 Timely review and disposition of identified nonconformance. The
frequency for MRB to convene is established at the facility level.
4.5.2 Documenting Material Review
nonconforming material report.
Board
disposition
on
the
4.5.3 Requesting investigation of problems when deemed necessary.
4.5.4 Assignment of CAPA for quality and/or technical problems when
deemed necessary.
5.0
4.6
Materials or Production Control is responsible for the purge and
quarantine of discrepant product at work in process, finished goods
inventory, pending MRB review, and disposition following Material Purge
Control Procedure, SOP-3-MD7012-A.
4.7
Facility Quality Manager and Material Manager are responsible for the
recall and quarantine of discrepant product in field following the Product
Recall Procedure SOP-3-MD7036-A.
PROCEDURE
5.1
Documenting Identified Nonconformance
5.1.1 When product does not conform to specified requirements, the
discrepancy is recorded in local electronic NCMR database
system, or on a Nonconforming Material Report, SOP-4-MD7045A.
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NONCONFORMING MATERIAL CONTROL & REVIEW
5.1.2 Nonconforming product is segregated and taken to the
appropriate designated nonconforming product location for
storage and disposition by the MRB.
5.2
Material Review Board process
5.2.1 The designated MRB coordinator guides the Material Review
Board members in the review of each pending NCMR in order to
reach a disposition.
5.2.1.1
If disposition cannot be reached at the time of the
review because further investigation is required, a
mutually agreed time for completion of disposition will
be established between the MRB members.
5.2.1.2
If disposition cannot be reached after further
investigation, the MRB chairperson must escalate the
problem to appropriate functions for consideration and
resolution.
5.2.2 When a disposition is reached by the MRB members, they
approve the NCMR under the appropriate functions they are
representing to denote concurrence with the NCMR
disposition.5.2.3 If the disposition requires customer response,
the Program/Account Manager is notified by the MRB coordinator
to obtain any of the following Customer concession dispositions.
5.2.3.1 Accept as is
5.2.3.2 Accept with rework
5.2.3.3 Reject
5.2.4 The customer contact is recorded on the NCMR, including the
response received from the Customer.
5.2.5 If the nonconforming product is dispositioned for rework, a rework
instruction is generated and approved by Customer,
Manufacturing Engineering, and Quality Assurance. Adverse
effect of the rework shall be determined to be inconsequential
before the commencement of the rework activity. All reworks are
subjected to the same acceptance test or inspection procedure
as specified in the quality plan. Results of inspection or test are
recorded on the NCMR or Rework Traveler (as appropriate).
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NONCONFORMING MATERIAL CONTROL & REVIEW
5.2.6 If MRB determines the need to put production or shipment on hold,
the decision is noted on the NCMR and the program manager is
notified. In cases where the customers input is required to restart production or shipment, written decisions for
approval/deviation from the customer shall be required.
5.3
Implementation of the Material Review Board Disposition
5.3.1 The discrepant product is processed based on the MRB
disposition.
5.4
5.3.1.1
Discrepant product requiring rework, are reworked in
accordance with approved rework instruction.
Reworked product is subject to the same inspection
and/or test as required.
5.3.1.2
Discrepant product disposition for scrap is disposed of
in accordance with an established facility procedure for
handling scrap.
5.3.1.3
Discrepant product requiring “Return to Vendor” is sent
back to the Supplier in accordance with established
facility procedure for handling parts to be returned to
supplier.
Discrepant Product Containment
5.4.1 Concurrent with the MRB activity is the containment of
discrepant product for work-in process, finished goods inventory
or product in the field, if applicable.
5.4.2 Recalled discrepant product shall be recorded on the NCMR and
forwarded to the QA Department for identification, control, and
disposition.
5.5
Investigation/Failure Analysis and Corrective Action
5.5.1 If the Material Review Board determines that the nonconformity
needs further investigation/failure analysis, it will be noted on the
NCMR form.
5.5.2 If the Material Review Board determines that the situation
warrants issuance of a Corrective Action Request, a Corrective
Action Request shall be processed in accordance with SOP-3MD8000-A, Corrective and Preventive Action procedure.
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NONCONFORMING MATERIAL CONTROL & REVIEW
6.0
QUALITY RECORDS
6.1
7.0
8.0
9.0
SOP-4-MD7045-A Nonconforming Material Report (or Local Electronic
NCMR Database system)
ASSOCIATED DOCUMENTS
7.1
SOP-3-MD7012-A, Material Purge Control Procedure
7.2
SOP-3-MD7036-A, Product Recall Procedure
7.3
SOP-3-MD7023-A, Handling, Storage, Packaging, Preservation and
Delivery SOP
7.4
SOP-3-MD8000-A, Corrective and Preventive Action
7.5
SOP-3-MD8002-A, Complaint Handling and Reporting Procedure
7.6
SOP-3-MD8009-A, Medical Device Reporting (MDR) Procedure.
REFERENCE DOCUMENTS
8.0
21 CFR Part 820 – Quality System Regulation
8.1
(EN) ISO 13485 - Quality Management Systems – Medical Devices –
System Requirements for Regulatory Purposes
8.2
SOR-98-282: May 7, 1998, Canadian Medical Device Regulation
MISCELLANOUS
9.1
The following table specifies the minimum signature requirements on
NCMRs.
Quality
Mfg Eng
Materials
Program Mgr
Customer
Material (Supplier
Related Issues)
X
X (optional)
X
X2
X1,2
Assembly Level (Process
Related Issues)
X
X
X (optional)
X2
X1,2
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NONCONFORMING MATERIAL CONTROL & REVIEW
9.2
If NCMR forms are electronically initiated using a database, a print out
of the form will be made for taking customer signatures and kept on file
as record of objective evidence.
Notes:
1) If customer has contractual obligation to have representation during MRB,
signature is required.
2) If MRB committee has determined that non-conformance needs to be
elevated to customer level, product manager is notified and customer is
brought in for review and signature is also required.
10.0
REVISION LOG
Rev.
Section
Date
Released
See Agile
See Agile
See Agile
A
B
C
None
4.4.1 & 5.1.1
4, 7
D
E
6.1
3.0, 4.0, 5.0,
6.0, 8.0, and
9.0
See Agile
See Agile
F
G
ALL
2.0
3.5,
3.9.1, 4.3.8,
7.0
See Agile
See Agile
H
4.3.3
See Agile
J
All
All
3.2
3.6
10-Oct-2014
Description Of Change
Initial Release
Allow use of NCMR database
Corrected ref to Recall proc & added to assoc
docs
Correct 4.4.1, 5.1.1, 6.1 to SOP-4-MD7045-A
Corrected procedure names, and added quality
records. Incorporated complaint handling,
initiation of investigations, and material purge
processes to define a closed loop
CAPA/Investigation process. Clarified
minimum signature requirements. Revised the
“superseded documents” sub-heading to
“Reference Documents”
Updated to new SOP format
Added back definitions.
Reference to Rework SOP, SOP-3-MD-7055-A,
Added requirement for QA manager to approve
all UAI, Include SOP-3-MD7055-A –Rework
Procedure
Updated footer
Updated the responsibility of QA Manager to
ensure finished devices that are being
scrapped are made inoperable before disposal.
Updated company logo and name change
Updated procedure to clarify product also
means material.
Added immediate containment requirement
Removed reference to Rework SOP and added
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NONCONFORMING MATERIAL CONTROL & REVIEW
K
3.2
3.2.1
12-Mar-2016
7.1
L
10-Oct-2017
2.1
3.4
3.5
3.15
M
7.6
3.5
5.2.5
23-Oct-18
rework instructions in place.
Added definition for Rework and Repair.
Updated procedure to include product that with
unidentified or suspect status be classified
nonconforming material.
Removed obsolete SOP-3-MD4014-A.
Updated to meet requirements of ISO
13485:2016.
Added definition of advisory notice.
Added documentation of investigation result in
NCMR.
Modified text for correct sequence of follow-up
actions addressing nonconforming products
detected.
Added requirement for advisory notice in
response to nonconforming product detected
after delivery.
Added associated MDR procedure.
Highlighted the requirement to notify persons or
functions directly responsible for the
nonconformance to prevent further
reoccurrence of the problem.
Added requirement to determine and ensure no
adverse effect before commencement of
rework activity.
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Official document and revision history is available on Agile