Unannounced Regulatory Audits Hitting Global Med Device Community

Unannounced Regulatory Audits Hitting Global Med Device Community

Sandy Carson-Hessen, Marketing Communications Manager, Pilgrim Quality Solutions

No one likes to be caught off-guard. Have you ever had a contractor show up at your home before you’ve even woken up? Or your child tells you he needs his original birth certificate the very next morning to register for camp. These facts of life often arise when you least expect it.

For Medical Device manufacturers worldwide, regulatory audits are a fact of life. And this year, they’ve also become a little more unpredictable. On September 24, 2013, the European Union Commission published a recommendation (2013/473/EU) regarding assessments and audits to be performed by Notified Bodies in the medical devices field at least once every three years. This recommendation applies to all device manufacturers that hold a CE certificate for products placed on the market within the European Economic Area, regardless of where their facilities are located in the world. The “unannounced” aspect is no laughing matter. Auditors have been known to give 10-minutes notice, or none whatsoever, and they expect to begin the audit within 30 minutes of their arrival at a facility. Admittedly, this is a new concept for the industry as a whole to absorb, but that’s not an excuse to be unprepared. So, you’d better put the coffee on…just in case auditors show up at your doors today.

“By failing to prepare, you are preparing to fail.” – Benjamin Franklin

The intention of the EU Commission’s recommendation is to ensure continuous compliance with quality management requirements. They’ve long understood that what auditors typically witness may not be an accurate representation of realistic, day-to-day compliance. Therefore it’s imperative that medical device manufacturers have a defined plan in place in the event of an unannounced audit. And now that this a reality, it’s wise to know what to expect.

4 ways unannounced audits are different from traditional quality audits

These surprise inspections are intended to promote quality and patient safety and avoid the sometimes lackadaisical approach to compliance. Therefore, they come with some new facets:

  1. Unannounced audits are truly unannounced – typically with no warning at all. To ensure that auditors are able to conduct unannounced audits as planned, Notified Bodies are asking manufacturers to provide information about when production activities will be shut-down.
  2. Unannounced audits will always be conducted by an auditing team of two or more, with at least one person that is qualified to review the technical documentation and compare it to the actual production activities. Even a 2-person team can spread your resources dangerously thin if you’re a small company that is used to providing a guide for only one auditor.
  3. Unannounced audits will involve more time spent by auditors in production areas, versus document reviews in conference rooms. Meetings will be brief and open because auditors need to review critical processes as quickly as possible, and Notified Bodies are expected to observe product testing.
  4. Unannounced audits will be conducted at supplier sites when critical processes are outsourced if this likely to ensure more efficient control. ISO 13485 certified suppliers have enjoyed a decade of little direct involvement by regulators, but unannounced audits are about to change this.

So how can we best prepare?

Preparation for unannounced audits should be very similar to your preparation for FDA inspections. Regularly repeat the standard process: Plan, Do, Check, Act. Document policies and procedures (Plan), train staff on them (Do), perform self-audits against company procedures (Check), and then address any nonconformances (Act). If you regularly repeat this process, you’ll be driving continuous improvement and you should be able to breathe easy.

“Organize, don’t agonize.” – Nancy Pelosi

But now you also will need to evaluate your supply chain — critical subcontractors and crucial suppliers — more rigorously to ensure they are also prepared for unannounced audits. A lack of cooperation from a supplier becomes a manufacturer’s problem, so stay on top of your suppliers and you can continue to breathe easy. Unannounced audits are the new reality for device manufacturers. They can be seen as an intrusion on “business as usual,” or a golden opportunity to improve quality systems and processes. And you already know, the higher the quality, the bigger the profits.

Strengthening Consumer Safety: Improving the Safety of Medical Devices

Please stay tuned to the Pilgrim blog for more on Unannounced Audits and other related topics.

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Sandy Carson

Marketing Communications Manager, Pilgrim Quality Solutions

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