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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 production of their products, these OEMs trust those CMs with patient lives and a critical piece of the OEM’s business.

To mitigate the risks inherent in outsourcing, OEMs must audit their CMs. In the high-stakes and highly regulated world of medical devices, verification—not trust—is what’s necessary.

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

Training Records
Without adequate training, even the most accurate and advanced inspection equipment on the market will produce wrong answers. Likewise, even the most detailed assembly work instructions assume some level of assembly skill and knowledge about how to use the necessary tools. That skill and knowledge is transferred, refreshed, and improved by training.

To ensure that the training required to produce your product is actually 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:

Does training and re-training happen as often as it should be? If there’s a training requirement for a task or subject which is constantly evolving, there should be recurring training. How frequently it occurs depends on the specific content of training, but the manufacturer’s personnel training records and their own training requirements as recorded in their internal policies should match. That documentation should also match current best practice. For example, an employee may need to receive training in basic machine shop safety only once, but more focused safety training may have to occur every time a new piece of equipment is introduced into the shop. That new machine may have unique safety features (like a light curtain) or safety hazards (e.g. laser light) which 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 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 change on work instructions or drawings, are all the necessary people trained? Depending on nature of the change, regulatory requirements, and the CMs quality management system (QMS) training may not be necessary for anyone. But of course, what is documented and what is done should match.

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

While on the floor, keep an eye out for any “shadow documentation”, such as uncontrolled printed copies of SOPs which have been annotated or corrected by hand. Any medical device CM worthy of your business should have an engineering change order (ECO) process that works so well that valid improvements and corrections are implemented quickly in the official controlled documents. Therefore, marked-up uncontrolled copies are unnecessary, in addition to being a violation of FDA and ISO 13485 document control requirements.

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

Checking the Checkers
A third area you should definitely focus attention on is the calibration records of any and all test and inspection equipment used for quality control testing. It’s good practice to re-calibrated every piece of equipment every year, but in some cases a more frequent schedule is needed. Any out of calibration equipment should be removed from the work area and set aside until serviced. Also, the certified accuracy and precision of each piece of equipment must meet or exceed the requirements of the measurements or other test results (like “go/no go” tests that use feeler gauges).

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 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 FDA registered and ISO 13485 certified medical contract manufacturer, we know firsthand the effort and diligence required to maintain a company-wide culture of quality, a culture that’s revealed 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, give us a call.

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Topics: medical manufacturing