amp Remote Auditing Purpose of Supplier Audits Qualify a New Supplier Ongoing Evaluation of a Supplier CAPA or Complaint Investigation Can I justify fewer supplier audits C an you justify ID: 558085
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Slide1
Supplier Auditing
& Remote Auditing Slide2
Purpose of Supplier Audits
Qualify a New Supplier
On-going Evaluation of a Supplier
CAPA or Complaint InvestigationSlide3
Can I justify fewer
supplier audits?Slide4
C
an
you justify
more
supplier audits?Slide5
Costs of Poor Quality
(COPQ)Slide6
Auditing 100% of your critical suppliers may seem impossible due to limited resources, but have you ever seen a cost/benefit analysis?Slide7
4 Most Common Auditing Methods
Element Approach
Procedural Approach
Product Approach
Process ApproachSlide8
Prioritizing Supplier Audits
FDA
Approach
Risk-based Approach
Logistical Approach
Strategic ApproachSlide9
Risk-Based Approach
Critical Subcontractors
Finished Device Manufacturers
Contract Sterilizers
Contract Labeling & Packaging
Crucial Components Suppliers
http://
bit.ly/Audit-Recommendations
Slide10
Strategic Selection of Auditors
Select
Auditors with Technical Expertise
Training Opportunities for New Auditors
Gathering Technical Information
Discussion of Design Changes / Process
Changes
Use
the Adjacent Link Auditing Approach
http://
bit.ly/AdjacentLinkAuditing
Slide11
Use Supplier Audit Template
Focus on Production & Process Controls
Shipping
Final Inspection
Manufacturing
In-Process Inspection
Labeling
Warehouse
Incoming Inspection
PurchasingSlide12
Supplier Audit AgendaSlide13
Auditing SCAR Closure
http://www.medicaldeviceacademy.com/supplier-auditing-tool-kit
Slide14
Remote Auditing
“Any time you can audit in a conference room, you could probably do the audit remotely.”
http://medicaldeviceacademy.com/4-ways-make-best-use-remote-audits
/
Slide15
When
NOT
to Audit Remotely
O
nsite
visits facilitate the building of supplier-customer
relationships.
T
ouring
facilities and watching demonstration of processes improves understanding of a supplier’s processes better than reading documents and records
can.
Cleanliness and capabilities of suppliers are best evaluated onsite, where camera angles can be used to crop out important details
S
ometimes
suppliers misrepresent their capabilities by showing photographs on their website of other companies.Slide16
What Areas Can You Audit Remotely?Slide17
Examples of Remote Audits
CAPA & SCARs
Management Review
Internal Auditing
Supplier Controls
Complaint Handling
Adverse Event ReportingSlide18
Other Remote Audits…
Re-Audits (i.e., SCAR follow-up)
When a critical team member can’t travel or is only needed for a short duration
To address issues of confidentiality when competitor product is also made at supplier.
Pre-cursor to a “for cause” audit / investigation
Participation in opening / closing meetingsSlide19
Allocation of ResourcesSlide20
Q & A
rob@13485cert.comSlide21
N
eed
a quotation for a supplier audit
?
Rob Packard
rob@13485cert.com
+1.802.281.4381
rob13485