One Possible Approach to an Approved Vendor List
Based on part / component criticality (to patient / end user / clinician).
Based on product risk, supplier / vendor
audit results, incoming QC trend data,
and other factors, a list of
approved vendors, and their criticality should be
established and maintained by QA,
separately, or in each vendor’s file.
Criticality
(based on risk to the patient / end user / clinician):
Criticality Category
|
Ranking
|
Category
|
01. Lab services –
contracted – clean room
/ controlled
manufacturing area testing,
biocompatibility, EO / BI / gamma
validation
and testing, GMP
compatibility
issues
|
High (Major)
|
Services
|
02. Calibration services -- contracted
|
High
|
Services
|
03. Patient fluid path contact
|
High
|
Parts
|
04. Tissue, bone and dentin contact
|
High
|
Parts
|
05. Sterile barrier
|
High
|
Parts
|
06. Sterilization services – contracted
|
High
|
Services
|
07. Patient contact, general
|
Moderate
|
Parts
|
08. Test equipment,
tooling, fixturing
manufacturers
– company validated
|
Moderate
|
Services / Equipment
|
09. Equipment, tooling,
fixturing;
manufacturers
– company validated
|
Low (Minor)
|
Services / Equipment
|
10. No patient contact
|
Low
|
Parts
|
11. Manufacturing
Materials – fully
removed
during processing (validated)
|
Low
|
Parts
|
Ranking explained (reference: “Guidance for the Content of Premarket
Submissions for Software Contained in Medical Devices Document”, May 11, 2005):
Ranking:
|
Explanation:
|
Major
|
A failure or latent flaw could
directly result in death or serious injury to the patient or operator. The
level of concern is also Major if a failure or latent flaw could indirectly
result in death or serious injury of the patient or operator through
incorrect or delayed information or through the action of a care provider.
|
Moderate
|
A failure or latent design flaw
could directly result in minor injury to the patient or operator. The level
of concern is also Moderate if a failure or latent flaw could indirectly
result in minor injury to the patient or operator through incorrect or
delayed information or through the action of a care provider.
|
Minor
|
Failures or latent design flaws
are unlikely to cause any injury to the patient or operator
|
6.11
Critical Vendors: Suppliers /
vendors ranked “High / Major” on the above tables
are determined to be “critical”. Critical suppliers are to be subjected to an
initial
site (or virtual) audit. Follow-up reviews / frequency will be
determined by patient /
user risk factors as mentioned
above and/or a Product Risk Management File, and the
quality of their deliverables, maintenance
of their CGMP compliance and/or
certifications.
The type of vendors to be
considered “critical” could consist of:
Independent test labs,
calibration services, contract sterilizers, manufacturers of
critical / high risk components,
compliance consultants, Notified-Bodies (generally
will not be audited by the
company, as they are subject to their own competent
authority oversight), and
similar.
Moderate risk vendors will be
subject to an initial desk audit (see Attachment 1),
supplemented by any additional
follow up phone interviews (document in memo to
file) and/or e-mail
correspondence (initialed and dated)
All High and Moderate vendors
will be subject to a periodic review, usually
annually, as to performance,
retention or replacement, and/or need for any
supplemental re-audit / re-inspection;
documented by a memo to their file.
Low risk ranked vendors will be
subject to review / action if any deliverable is found
non-conforming, and such review
will be included in the NCMR or other CAPA
documentation.
-- jel@jelincoln.com
