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The FDA expects you to hold your suppliers, vendors and contractors in a state of control. You are responsible if an inspection turns up problems with materials or services you have outsourced.
You need a supplier auditing program that helps you stay on top of all your outsourced operations. The FDAnews Brief SupplierAuditing: A Four-Part Plan helps you build a system that shows the FDA and other regulators that you hold the reins when it comes to supplier quality:
Start with risk assessment. Not every supplier needs a comprehensive annual audit. Some present bigger potential problems than others and should be monitored frequently. Others may be trusted long-standing contractors that you check up on only every few years.
Think about what you will evaluate. Do you need to examine a supplier’s entire quality system, or just a particular process or procedure?
Map out the audit. What steps will you take and what questions need to be answered? Create a checklist to keep the audit on track. Click here to see the sample audit checklist.
Organize the information you collect. Keep a file on each supplier — a dossier, if you will — and develop a list of those you have given your stamp of approval. Having these records on hand will be invaluable when FDA investigators start looking at your supplier management system.
Set your standards. Think about the qualities that make a good auditor and choose accordingly. Then consider how you can communicate your audit observations to the supplier in a way that ensures understanding and agreement.
Prepare to defend your audit. What records will you need to show investigators? (Hint: see #4 above.) Know what questions they will ask and red flags they will look for.
Get your supplier audit program in shape now with SupplierAuditing: A Four-Part Plan.
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Who Will Benefit
Quality/compliance lead
Supplier management system head
Consultants/independent auditors
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