Level 2 – Standard Operating

Procedure

Control of Non-Conforming Product

Doc. Number: 932-QA13-001

Rev Number: AL

Table of Contents

1 Purpose .............................................................................................................................................2

2 Scope ................................................................................................................................................2

3 Responsibility ..................................................................................................................................2

4 Reference Documents ......................................................................................................................3

5 Tools and Materials Required ..........................................................................................................3

6 Definitions ........................................................................................................................................3

7 Procedure .........................................................................................................................................4

8 Flow Chart .......................................................................................................................................8

9 Revision History ..............................................................................................................................9

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 Level 2 – Standard Operating
Procedure

Control of Non-Conforming Product

Doc. Number: 932-QA13-001

Rev Number: AL

1 Purpose
The purpose of this document is to establish the Control of Non-conforming Product
process and procedure fulfilling the requirements of the FDA Quality System Regulation
(21CFR Part 820); ISO 13485; 93/42/EEC Medical Device Directive; and the Canadian
Medical Device Regulation, as listed in the SOP/Regulatory Requirements Matrix
(Appendix B) in the Cynosure Quality Manual (931-QA01-001).

2 Scope
This procedure is applicable to all parts and/or components identified during the
manufacturing process as not conforming to Cynosure’s requirements or specification.
Nonconforming parts and components are tracked and dispositioned on the NCR Form.
Defects identified in assemblies and finished products during the manufacturing process
are not covered by this procedure and are handled via the Process Control procedures (932-
OP09-001 and 09-00-00) and by 932-QA10-001 Quality Control Inspection & Testing, and
do not require a 934-QA13-001 Non-Conformance Report (NCR).

3 Responsibility
 Responsibility for updating this document is outlined in the Attribute section in the
PLM database.
 It is the responsibility of the departments and individuals called out in the procedure to
ensure that this procedure is followed as required.
 This procedure is applicable to all activities carried out when material does not conform
to Cynosure's requirements or specifications.
 Quality Assurance is responsible for overseeing the process, including evaluation of non-
conformance reports, assurance of proper material disposition, and appropriate
approvals according to this procedure.

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 Level 2 – Standard Operating
Procedure

Control of Non-Conforming Product

Doc. Number: 932-QA13-001

Rev Number: AL

4 Reference Documents
 21 CFR Part 820 FDA Quality System Regulations (QSR)
 ISO 13485 Medical devices – Quality management systems – Requirements for
regulatory purposes
 93/42/EEC Medical Device Directive (MDD)
 SOR/98-282 Canadian Medical Device Regulation (CMDR)
 931-QA01-001 Cynosure Quality Manual
 932-OP09-001 Process Control (Cynosure)
 932-QA10-001 Quality Control Inspection & Testing
 932-QA14-001 Corrective & Preventive Actions
 933-QA06-001 Supplier Quality
 933-QA10-001 SyteLine / QCS User’s Guide
 934-QA13-001 Non-Conformance Report (NCR)
 09-00-00 Process Control (ConBio)

5 Tools and Materials Required

 N/A

6 Definitions
 Material Review Board (MRB): The committee responsible for the disposition of all non-
conforming material. In addition, MRB shall decide whether corrective action is
required from either an outside supplier or internally. MRB consists of a minimum of 1
representative from Quality and Operations (required); and representatives from
Regulatory, Engineering and Finance (as needed).
NOTE: The signature approvals in the “Disposition Approval” section of the NCR form
indicate approval of the listed disposition and the rework instructions (if applicable).
 Non-Conformance Report (NCR): The record used to capture the description and
disposition of the Non-Conforming Material along with appropriate approvals. NCR
approval requirements vary depending on the disposition of the materials. Approval
requirements are defined on the NCR form. Additional approval signatures (above
requirements) may be added to the form (if applicable).
 Non-Conforming Material: Purchased parts or components that do not meet specification
or has functionally failed due to a supplier quality defect or production related issue.
 Return to Vendor (RTV) / Cynosure Issue: Non-conforming material from a vendor
which may have been damaged at Cynosure or the original vendor is unclear. It is
returned to the vendor (if known) for rework or replacement.

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 Level 2 – Standard Operating
Procedure

Control of Non-Conforming Product

Doc. Number: 932-QA13-001

Rev Number: AL

 Return to Vendor (RTV) / Vendor Issue: Non-conforming material from a vendor, which
does not meet Cynosure specifications. It is returned to the vendor for credit, rework or
replacement.
 Rework: Non-conforming purchased parts or components that can be internally reworked
to an acceptable condition (rework instructions required). The rework is to be done
according to original specifications. Rework must be re-inspected by QC. The results of
the inspection are documented on the NCR report.
NOTE: The signature approvals in the “Disposition Approval” section of
the NCR form indicate approval of the listed disposition and the rework
instructions (if applicable).
 Scrap Material: Non-conforming material that cannot be returned to the supplier or
reworked to an acceptable condition. It is rejected and destroyed.
 Use-As-Is (UAI): Material that is thought to be non-conforming and is suitable for its
intended purpose and does not compromise regulatory requirements (justification
required).
 No Problem Found: Material that was thought to be non-conforming but does not actually
have an out of specification condition.

7 Procedure
7.1 Identification

7.1.1 Typical sources of non-conformances include, but are not limited to:
 Incoming Material
 Production Material.
 Stock

7.2 Documentation

7.2.1 Upon the discovery of non-conforming material by any department, a

Non-Conformance Report (NCR) is initiated. The initiator of the NCR
form only needs to fill in the top (shaded) section of the form.

7.2.2 The NCR must remain at all times with the non-conforming material.

7.2.3 If the non-conforming material is found at Incoming Inspection, Quality

Control will initiate a NCR form, assign the NCR a unique number, and
enter the initial information into the Data Management System per 933-
QA10-001.

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 Level 2 – Standard Operating
Procedure

Control of Non-Conforming Product

Doc. Number: 932-QA13-001

Rev Number: AL

7.2.4 If the non-conforming material is found during the manufacturing process,

the defective part or component is recorded on a NCR form and given to
the Materials Handling group for a replacement, and the assembly or
finished product is repaired. The Material Handling group completes the
transaction in SyteLine and places the defective part or component with
the NCR form onto the MRB rack for disposition. Non-conforming
material from locations other than Incoming Inspection will have the NCR
number assigned along with the disposition at step 7.3.3.

7.3 Material Review Board

7.3.1 Non-conforming material is segregated and moved (along with the NCR
form) to the Material Review Board (MRB) area to await disposition by
the MRB Committee.

7.3.2 The MRB evaluates the NCR and comes to a group conclusion as how to
appropriately disposition the material. Upon disposition, the NCR form is
completed and signed by MRB. Refer to the flowchart for appropriate
signatures.

7.3.3 Quality Assurance enters the disposition and any other required
information Data Management System per 933-QA10-001.

7.4 Corrective and Preventive Actions

7.4.1 The MRB investigates and determines the cause of non-

conformances.

7.4.2 For supplier related issues, a Supplier Corrective Action Request (SCAR)
may be required. If the “Corrective Action Request” section of the NCR
form is marked “YES”, a SCAR number will be assigned, and a copy of
the NCR will be sent to the supplier. SCARs are initiated and handled in
accordance with 932-QA14-001 Corrective and Preventive Actions and
933-QA06-001 Supplier Quality. Operations/Purchasing and Quality
Assurance work with the supplier to resolve any product quality or other
issues.

7.4.3 For other issues, a Cynosure Corrective Action Request (CAPA) may be
required. If the “Corrective Action Request” section of the NCR form is
marked “YES”, a CAPA number will be generated and documented on the
NCR form. CAPAs are initiated and handled in accordance with 932-
QA14-001 Corrective and Preventive Actions.

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 Level 2 – Standard Operating
Procedure

Control of Non-Conforming Product

Doc. Number: 932-QA13-001

Rev Number: AL

7.4.4 SCARs and/or CAPAs may be initiated by the MRB at time of disposition
and during weekly, monthly and/or annual review of nonconforming
material trend data.

7.5 Material Transfer and Closure

Note: A representative from Quality and Operations must approve all NCR forms,
regardless of disposition.

7.5.1 If material is dispositioned as “Use-As-Is”:

7.5.1.1 Engineering evaluates to ensure requirements are met and signs

the NCR form.

7.5.1.2 Regulatory evaluates to ensure regulatory requirements are met

and signs NCR form along with a justification.

7.5.1.3 The material may be moved to the stock room. The NCR form is
forwarded to QA where it is closed and filed.

7.5.2 If material is dispositioned as “Rework”:

7.5.2.1 The original NCR must remain with the material and a copy of
the NCR must be filed in the box on top of “MRB1” rack. This
NCR copy must contain the name of the person removing the
material from MRB, the date, and the new location of the
material.

7.5.2.2 The rework instruction is documented and evaluated for adverse

effects by Engineering. Engineering then signs the NCR form.

7.5.2.3 The individual completing the rework signs and dates the NCR
form once complete.

7.5.2.4 When the rework has been completed, the reworked material will
be inspected by QC and if accepted, the material will be moved
to the stock room.

7.5.2.5 The original NCR form is forwarded to QA where it is closed

and filed. The NCR copy must be discarded at this time.

7.5.3 If material is dispositioned as “RTV”:

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 Level 2 – Standard Operating
Procedure

Control of Non-Conforming Product

Doc. Number: 932-QA13-001

Rev Number: AL

7.5.3.1 The material is returned to the original supplier along with a

copy of the NCR form.

7.5.3.2 The original NCR form is forwarded to QA where it is closed

and filed.

7.5.4 If material is dispositioned as “Scrap”:

7.5.4.1 The material is destroyed as soon as possible. Any scrap value

over $250 will require Finance to sign off the NCR form.

7.5.4.2 The original NCR will be forwarded to QA for closure and filing.

7.6 Analysis of Data

7.6.1 An analysis of non-conforming material data is generated and reviewed in

accordance with 932-QA20-001 Statistical Techniques.

7.7 Records

7.7.1 Quality Assurance reviews all non-conforming reports to ensure

completeness, correctness, and that any resulting corrective actions
(CAPA or SCAR) have been initiated.

7.7.2 Operations/Purchasing maintains the MRB log containing material

disposition information.

7.7.3 Records of non-conforming product and material are retained in

accordance with 932-QA16-001 Control of Quality Records.

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 Level 2 – Standard Operating
Procedure

Control of Non-Conforming Product

Doc. Number: 932-QA13-001

Rev Number: AL

8 Flow Chart
Non-Conformance Flowchart

no Move parts with

Non-Conformance Complete Gray sections of Non-conformance
NCR report to
Identified NCR Report found at Inc Insp?
MRB

yes

MRB Committee
QC logs the NCR into the
Dispositions parts
NCR Database

Use As Is?
Return To Vendor / Return To Vendor /
No Problem found no Cynosure Issue?
no Scrap? no Vendor Issue?
no Rework? no

yes
yes yes yes yes
Justify UAI
Obtain Quality, Obtain Quality, Obtain Quality,
Obtain Quality, Record internal
Operations Operations Operations
Operations Rework Instructions
Signatures Signatures Signatures
Signatures Obtain Quality,
Operations,
Regulatory, and
Send parts back to Obtain Finance Obtain Quality,
Send parts back to Engineering
Return parts to vendor signature if value Engineering,Operations
vendor. Signatures
stock is over $250 Signatures

Move parts to Move parts to stock

Vendor Rework Area and
Internal Corrective
Action required?
no Vendor Issue? yes Corrective Action have parts reworked
required?
no
yes
yes yes QC re-inspects Vendor
no parts to original Corrective Action
Make a copy of NCR.
specifications Required?
Original Initiate CAPA Original to QA. Send
NCR to with CAPA copy of NCR to no
QA form #934- Vendor requesting yes
QA14-003 SCAR

Do parts meet
Make a copy of
specs? Original NCR to NCR. Original to
Issue CAPA QA QA. Send copy of
Update NCR no NCR to Vendor
Database & Close requesting SCAR
NCR

Issue CAPA

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 Level 2 – Standard Operating
Procedure

Control of Non-Conforming Product

Doc. Number: 932-QA13-001

Rev Number: AL

9 Revision History
Rev Originator ECO Description
A RL 01976 Initial Release
B MB 02318 Updated per ISO audit
C MB 03162 Rewrote procedure, consolidate w/932-QA14-001
D MB 03548 Rewrote to correct practice
E MB 03726 Defined minor assy. NCRs; defined initiator fill req’mt & deleted Purchasing for
return info
F MM 04139 Corrected typos; added MRB Quarantine label info
G MI 04175 Added reference to form 934-QA13-003
H MI 04321 Added definition for non-conforming material
J MI 04388 Added section 6.10 for International subsidiaries
K MI 04559 Changed to streamline process
L MI 04656 Updated per internal audit
M MI 04854 Updated rework flow
N SM 05261 Added Corrective Preventive Action Report refs
P SM 05368 Corrected “Corrective/Preventive Action Report” Number
R SM 05407 Changed to reflect current practices
T SM 05533 Updated per 2004 audit
U SM 05712 Updated for accuracy
V DT 05805 Amended 6.7 to add Finance signature over $250.00
W SM 05824 Updated per 2005 audit
Y SM 05958 Modified procedure, added flowchart, attached NCR report to procedure
AA RB 06415 Clarify regulatory requirements
AB RB 06536 Add No Problem Found category, add Regulatory for Use As Is disposition
signoff, add Engineering signoff to determine adverse effects prior to rework
AC RB 06692 Updates to form
AD MF 06855 Minor changes to reflect current practices
AE RB 06932 Minor update and simplify form
AF TC 07215 Incorporate use of new QCS module in Syteline ERP system
AG MF 07283 Standardize “Purpose” section across all Level II SOPs. Update “Reference
Document” section to remove “quad-zeros” and add references to applicable
standards and regulations.
AH MF 07412 Remove NCR form and make minor document updates
AJ JF 07951 Clarify the process and stress requirement to keep NCR form with nonconforming
product at all times. Addresses CAPA 11-026.
AK FG/MF 08575 Clarify scope to exclude finished products, include ConBio requirements.
AL AP/EP 09120 Clarify responsibilities to address CAPA 13-022, update to add 933-QA06-001,
add section 7.7. Records, general process clarifications, reinstated revision history.

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