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InfoCard #: COMM-QA-002 JA1 Rev. 06 Effective Date: 19 Mar 2019
DUKE
DOCUMENT NUMBER: COMM-QA-002 JA1
DOCUMENT TITLE:Supplier Risk Assessment JA1
DOCUMENT NOTES:
Document Information
Revision: 06 Vault: COMM-QA-rel
Status: Release Document Type: COMM-QA
Date Information
Creation Date: 10 Oct 2018 Release Date: 19 Mar 2019
Effective Date: 19 Mar 2019 Expiration Date:
Control Information
Author: RB232
Previous Number: COMM-QA-002 JA1 Rev 5
Owner:
Change
BS76
Number: COMM-CCR-075
CONFIDENTIAL - Printed by: ACM93 on 19 Mar 2019 08:02:55 am
InfoCard #: COMM-QA-002 JA1 Rev. 06 Effective Date: 19 Mar 2019
COMM-QA-002 JA1SUPPLIER RISK ASSESSMENT
1 PURPOSE
1. 1 To provide guidance for assessing the level of risk/potential risk forsuppliers/vendors and for determining the type and frequency of supplier/vendorqualifications.
2 INTRODUCTION
2. 1 Suppliers should be selected according to their ability to reliably provide high-quality materials/products that meet manufacturer's defined requirements andexpectations. Supplier qualification is based on a Quality Management System(QMS) that ensures that any goods, materials, services or components comingfrom a supplier are produced and delivered under a set of controls that ensuretheir predetermined standards are met. The objective is to preempt qualityproblems, prevent defects and guarantee consistent quality through effectivemanagement and monitoring of suppliers.
2. 2 Critical materials that have the potential to affect quality should be qualifiedbefore use and should be obtained from suppliers who can meet definedrequirements. Once suppliers are qualified, periodic evaluation of supplierperformance helps to ensure the supplier's continued ability to meet requirements.
3 SCOPE AND RESPONSIBILITIES
3. 1 This JA applies to the Quality Systems Unit (QSU) when determining the typeand frequency ofsupplier/vendor qualifications.
3.2 The QSU in collaboration with the Program/Medical Director, is responsible fordetermining the type and frequency ofsupplier/vendor qualifications.
4 DEFINITIONS/ACRONYMS
4. 1 JA-Job Aide
4.2 QSU - Quality Systems Unit
5 MATERIALS
5. 1 N/A
6 EQUIPMENT
6. 1 N/A
7 SAFETY
7. 1 N/A
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CONFIDENTIAL - Printed by: ACM93 on 19 Mar 2019 08:02:55 am
InfoCard #: COMM-QA-002 JA1 Rev. 06 Effective Date: 19 Mar 2019
8 PROCEDURE
8. 1 Every supplier will receive an initial Supplier Impact Assessment COMM-QA-002FRM2.
8.2 Based on the results of the initial Impact Assessment, perform a risk assessmentfor the material/service based on the following risk matrix and identify thematerial/service risk grade (Z, A, B, C or D).
8. 3 Assess the potential patient impact by considering the impact on patient safety, ifthe material/service failed.
8.4 When assessing the likelihood ofmaterial/service failure, consider the followingfactors:
8. 4. 1 The complexity of the material/service
8.4.2 The size and history of the supplier
8.4. 3 The relation of the material/service to the supplier's core business
8.4.4 The reputation of the supplier
8.4. 5 Relevant certifications (e.g. ISO)
8.4. 6 The overall historical integrity issues of the material/service
Likelihood ofMateriaI/Service
Failure ThatWould Not BeReadily Detected
HIGH/1\ \
LOW
5
4
3
2
1
A
A
z
z
z
1
B
B
A
A
z
2
c
c
B
A
z
3
LOW
D
c
c
B
A
4
D
D
c
B
A
5
-*' HIGH
Potential Patient Impact
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InfoCard #: COMM-QA-002 JA1 Rev. 06 Effective Date: 19 Mar 2019
8. 5 Based on the risk grade, determine the appropriate degree of supplier follow-upqualification:
Risk Grade
z
A
B
c
D
Qualification Required
Supplier Impact Assessment
Supplier Questionnaire
Supplier Questionnaire
Supplier Questionnaire
Audit
Frequency
Initial impact assessment to bereviewed bienniallyInitial Questionnaire, then only ifsignificant change to material ormanufacturing process. Impactassessment to be reviewed
biennially.Biennial Questionnaire and impactassessment.
Annual Questionnaire and impactassessment.
Audit (desk or onsite) if deemedappropriate by the QSU and/orMedical/Program Director. AnnualQuestionnaire and impactassessment.
8. 6 If a Supplier Questionnaire is deemed necessary, this risk assessment should becompleted again in conjunction with review of the supplier's responses onCOMM-QA-002 FRM1. Document any changes in the risk grade as outlined onthe supplier questionnaire.
9 RELATED DOCUMENTS/FORMS
9. 1 COMM-QA-002 Supplier Qualifications
9.2 COMM-QA-002FRM1 Supplier Questionnaire
9. 3 COMM-QA-002 FRM2 Supplier Impact Assessment
9. 4 COMM-QA-002 FRM3 Qualifications Review Form
10 REFERENCES
10. 1 American Association of Blood Banks. Standards for Hematopoietic ProgenitorCell and Cellular Product. Current edition
10.2 Foundation for the Accreditation of Hematopoietic Cell Therapy (FACT) andNetcord. International Standards for Cord Blood Collection, Processing, Testing,Banking, Selection and Release Current edition
10. 3 U. S. Food and Drug Administration. Vaccines, Blood & Biologies. 7342. 001 -Inspection of Licensed and Unlicensed Blood Banks, Brokers, ReferenceLaboratories, and Contractors. Completion Date: September 30, 2009
10.4 21CFR Part 820. 50, Purchasing Controls
10. 5 21 CRF Parts 211. 22, 606, 1271. 210
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InfoCard #: COMM-QA-002 JA1 Rev. 06 Effective Date: 19 Mar 2019
11 REVISION HISTORY
Revision No.
06Author
R. BryantDescription of Change(s)
. Clarified frequency of items needed forrequalification
. Added option for desk audit.
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InfoCard #: COMM-QA-002 JA1 Rev. 06 Effective Date: 19 Mar 2019
Signature Manifest
Document Number: COMM-QA-002 JA1
Title: Supplier Risk Assessment JA1
Revision: 06
All dates and times are in Eastern Time.
COMM-QA-002 JA1 Supplier Risk Assessment
Author
Name/Signature
Richard Bryant (RB232)
Medical Director
I Title 1 Date ___ ___lj^eanLn?l'?eason_14 Mar 2019, 09:43:29 AM Approved
Name/Signature
Joanne Kurtzberg(KURTZ001)
Quality
i Title Date Meaning/Reason
14 Mar 2019, 09:55:31 AM Approved
I Name/SignatureLisa Eddinger (LE42)
Document Release
! Title I D?t^.. __ ...... - .... J l!l/leani!1?/?eason14 Mar 2019, 11:34:04 AM Approved
|,j^, !Z12^!S!]^!l!I^.-,^^^, »^,,.
J -Zitle-Sandy Mulligan (MULL1026)
J Date j Meaning/Reason18 Mar 2019, 05:48:35 PM Approved
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