1. SUPPLIER AUDITING
2 May, 2012

2. Supplier Auditing
• Why Audit?
• Certification
• Regulation
• Address risks
• Add value

3. Supplier Auditing
 Who to Audit?
◦ Decision based on Risk
 New supplier
 Critical supplier
 Quality problems
 Product or process changes
 Customer complaint
 Other?
◦ Create a plan you can justify

4. Supplier Auditing
 Auditor Characteristics
◦ Training! Auditor certification to ISO 9000 or 13485 is
good.
◦ Know your standards! And know what is different
between the standards and what STORZ needs the
supplier to provide
◦ There are lots of ways to fulfill a requirement. Make
sure the requirement is fully defined, then give the
supplier room to fulfill it in a way that is easy for them
◦ Be clear with regards to what you don’t know, and let
the supplier demonstrate their expertise.

5. Supplier Auditing
 Auditor Characteristics
◦ Point out the good things, especially if there is
anything you can learn from them
◦ Don’t mention other suppliers
◦ Be unrelentingly positive!

6. Supplier Auditing
 Steps
◦ Contact the supplier and schedule
◦ Develop the audit plan and SHARE it with the supplier prior to the
audit date
◦ Be aware of the supplier’s sensitivity to intellectual property!
 It is possible to do an effective supplier audit without seeing the
process at all! Although this is not ideal.
 Sign NDA if required
◦ Arrive at the supplier on-time, and with a professional manner
◦ In the opening meeting
 Introduce the audit team, and explain the purpose of the visit
 Establish timing for the day (topics, breaks, etc)
 Reiterate the confidential nature of the information provided
 Answer any questions with regards to the audit plan, schedule,
process, etc

7. Supplier Auditing
 Steps (cont)
◦ Proceed through the audit, maintaining an open mind
 Record objective evidence
 Review potential findings or opportunities as they come up, and
acknowledge good practices!
 Some activities may be KS specific
◦ Closing meeting – review a summary of the audit results and get
agreement from the supplier to correct
 Establish method for corrective action and follow up
 Thank the supplier’s team for their time
 Accentuate the positive!
◦ Complete follow-up
 Objective evidence of effectiveness of the solution is required
 Determine if any additional actions (data review, follow up audit,
incoming inspection) are required.

8. Supplier Auditing
 What’s in an audit plan?
◦ Needs to evaluate supplier against KS needs – NOT
compliance to standard
 Although one or more standards may be used as a basis
 As a result, the supplier may have some systems special to
STORZ. Any systems of this type should be specifically
addressed
◦ Review sample audit plan

9. Supplier Auditing
 Tips
◦ Try to set the supplier at ease. As part of the opening
meeting, help them see your visit as an asset
◦ Ask to be shown evidence, rather than asking to see
a procedure. It is more efficient.
◦ If you think there is a problem, ask the supplier to
explain. It will be better if they find the problem, than if
you point it out.
◦ Be in and out of the facility as quickly as possible.
This shows respect for the supplier’s time.

10. Supplier Auditing
 Audit Report (minimum content)
◦ Attendees and date of audit
◦ Executive Summary
◦ Statement of “samples review”
◦ Evidence list
◦ Required corrections
◦ Auditor signature
 Let’s practice! (if time allows)

11. Questions?