slide 1 of 21 robert packard, president [email protected] supplier auditing & remote auditing

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Robert Packard, President

www.MedicalDeviceAcademy.com

[email protected]

Supplier Auditing

& Remote Auditing

http://www.medicaldeviceacademy.com/

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Purpose of Supplier Audits

• Qualify a New Supplier

• On-going Evaluation of a Supplier

• CAPA or Complaint Investigation


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Can I justify fewersupplier audits?


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Can you justify moresupplier audits?


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Costs of Poor Quality (COPQ)


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Auditing 100% of your critical suppliers may seem impossible due to limited resources, but have you ever seen a cost/benefit analysis?


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4 Most Common Auditing Methods

1. Element Approach

2. Procedural Approach

3. Product Approach

4. Process Approach


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Prioritizing Supplier Audits

• FDA Approach

• Risk-based Approach

• Logistical Approach

• Strategic Approach


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Risk-Based Approach

• Critical Subcontractors– Finished Device Manufacturers– Contract Sterilizers– Contract Labeling & Packaging

• Crucial Components Suppliers

http://bit.ly/Audit-Recommendations




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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




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Use Supplier Audit Template

• Focus on Production & Process Controls– Shipping– Final Inspection– Manufacturing– In-Process Inspection– Labeling– Warehouse– Incoming Inspection– Purchasing


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Supplier Audit Agenda


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Auditing SCAR Closurehttp://www.medicaldeviceacademy.com/supplier-auditing-tool-kit


http://www.medicaldeviceacademy.com/supplier-auditing-tool-kit

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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/




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When NOT to Audit Remotely

• Onsite visits facilitate the building of supplier-customer relationships.

• Touring 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

• Sometimes suppliers misrepresent their capabilities by showing photographs on their website of other companies.


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What Areas Can You Audit Remotely?


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Examples of Remote Audits

• CAPA & SCARs• Management Review• Internal Auditing• Supplier Controls• Complaint Handling• Adverse Event Reporting


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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 meetings


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Allocation of Resources


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Q & A

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mailto:[email protected]

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Need a quotation for a supplier audit?

Rob Packard

[email protected]

+1.802.281.4381

rob13485


mailto:[email protected]

slide 1 of 21 robert packard, president [email protected] supplier auditing & remote auditing

Documents

lyadjacentlinkauditing

robert packard

process approach slide

supplier audit agenda

complaint investigation

element approach

product approach

procedural approach