5 Areas of Focus When Conducting Supplier Audits

2017-bl-tips-when-conducting-supplier-audits-page-imageConducting supplier audits is a well-established way to identify, eliminate and prevent quality problems in a supplier’s products, processes or management system before the problems spread. Still, there are ways to improve supplier audits.

In a recent article for Pharmaceutical Manufacturing, MasterControl's Terrance Holbrook, a senior product manager with 20 years of industry experience in manufacturing fields, highlighted five often-overlooked actions to better conduct supplier audits.

5 Things to Consider

#1 Conduct exhaustive pre-audit research.
 Before setting foot on the audit site, the audit team should review both parties’ expectations and responsibilities as laid out in the quality agreement, and prepare a prioritized checklist of items to review based on the material, component or service supplied. Additional areas of pre-audit research should include: past audit reports; company history using the supplier’s product; current product specification; importance of the product to the company; whether the product has ever failed; alternative manufacturers qualified; and interviews with in-house personnel about the supplier and the product.

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#2 Audit a supplier's reputation online. Beyond the traditional audit-preparation tasks, the audit team should probe the supplier’s online presence. Examine the supplier’s own website and social media profiles, and look at review sites like Consumer Reports, CNET and the Better Business Bureau. What do other customers and users say about the company and its offerings? Also, search the U.S. Food and Drug Administration (FDA) website for information relevant to suppliers’ compliance with Current Good Manufacturing Practice (CGMP) regulations, including whether the supplier is the subject of an FDA warning letter, import alert or recall.

#3 Don’t take customer complaints for granted. Customer complaints, while common inspection targets, should not be taken for granted. They are a crucial source of information about the performance and quality of products under actual usage, which is why capturing and investigating issues received through this channel is important. Look for repetitiveness to determine whether other clients have had similar complaints about both the product you currently purchase and the supplier’s product line outside your current purchases. If evidence in customer complaints shows that the supplier has an issue, that evidence will be found through paperwork.


#4 Know if a supplier is outsourcing. If a supplier is outsourcing parts of its process, it’s important that you are notified of that fact and that you ensure the supplier has quality agreements with its own suppliers. The audit team should ask to review the supplier’s audit findings of its own suppliers; if the supplier doesn’t allow that, then the team should ask to see the supplier’s incoming inspection of subcontracted materials, as well as any other documentation that will prove the supplier is holding its vendors to quality standards and receiving quality items.

#5 Keep the audit on track. If it seems like a supplier is being evasive during an inspection, or is not providing certain quality-related documents, it may be a deliberate attempt to hide quality issues. If the supplier is aggressively leading the audit team down certain paths during a tour, it may be to distract from process problems like nonconformances, deviations or failed lots. While it’s important to review processes and documents during an audit, it’s equally important to actively listen to the supplier, read and understand situations, and stay focused on achieving objectives.

To learn more about how to leverage audits to ensure supplier quality, check out Terrance Holbrook’s “5 Tips for Conducting a Supplier Audit” published in the May 2017 issue of Pharmaceutical Manufacturing magazine. You can read the original article here.

2016-nl-bl-author-david-butcherDavid Butcher has been writing about business and technology trends in the industrial B2B space for more than a decade. Currently a marketing communications specialist at MasterControl, he previously served as editor of ThomasNet News’ Industry Market Trends and as assistant editor for Technology Marketing Corp.’s Customer Interaction Solutions. He holds a bachelor’s degree in journalism from the State University of New York, Purchase.