Top 3 Things to Look for When Auditing a Medical Manufacturer

Medical device OEMs rely on the competence and compliance of their contract manufacturers (CMs) to continuously deliver high-quality parts and products on demand. By outsourcing the production of their products, these OEMs trust those CMs with patient lives and a critical piece of the OEM’s business.

But what exactly should OEMs verify when they audit their medical manufacturing partners?  Among the numerous details covered in regulatory and ISO audits, a few key items must be included in every audit of a medical manufacturer.

To ensure that the training required to produce your product is occurring, OEMs need to pay close attention to training records. During an audit, the manufacturer’s internal training records should answer “Yes” to the following questions:

Is training and re-training happening frequently enough? If there’s a training requirement for a task or subject that is constantly evolving, there should be recurring training. How frequently it occurs depends on the specific training content, but the manufacturer’s personnel training records and their training requirements, as documented in their internal policies, should align. That documentation should also match current best practices. For example, an employee may need to receive training in basic machine shop safety only once. Still, more focused safety training may be necessary whenever a new piece of equipment is introduced into the shop. That new machine may have unique safety features (such as a light curtain) or safety hazards (e.g., laser light) that operators need to be aware of.

Are workers only performing tasks they’ve been trained on? If a new procedure or a new revision of an existing one requires training, only workers who have been trained on it should be able to sign off on the device history record (DHR) as having performed it. An audit shouldn’t uncover someone performing a new assembly or inspection procedure before they were trained on it.

When revisions are made to work instructions or drawings, do all affected employees receive appropriate training? Depending on the nature of the change, regulatory requirements, and the CM quality management system (QMS), training may not be necessary for anyone. But of course, what is documented should match what is done.

Does the Whole Company Take Quality Seriously?
Thorough audits shouldn’t stop at just examining paperwork. OEMs should feel free to ask shop-floor staff about basic quality-system knowledge. They should know their company’s quality policy, where to find the standard operating procedures (SOPs) relevant to their jobs, and, if applicable to their job duties, where to find the current released versions of part and assembly drawings.

Finally, look for any processes that rely on tribal knowledge instead of a well-documented SOP. If you happen to be near a technician performing rework, ask to see the repair or assembly documentation detailing the reassembly steps or the part replacement procedure. FDA auditors use random spot checks like these, and you should use them too.

By auditing your medical contract manufacturer, you have an opportunity to verify their processes meet your standards and a chance to spot and help correct problems before the FDA does. Keeping your CM in compliance with your quality system requirements reduces your risk of adverse regulatory actions, decreases the chances of supply chain disruption due to supplier noncompliance, and most importantly, helps keep the patients who rely on your medical products safe.

As an ISO 13485 certified medical contract manufacturer, we know firsthand the effort and diligence required to maintain a company-wide culture of quality, one that's evident in audit after audit.  That’s why our OEM customers trust us with their customers, patients, and business.  If you’re looking for a trustworthy medical manufacturer, reach out to us. 

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