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Unannounced Audits Are Here – Are You and Your Suppliers Ready?

In 2015, Global IVD and medical device manufacturers, their CRITICAL material/component suppliers, and subcontractors will undergo 5,000 unannounced audits by Notified Bodies (NBs). Notified Bodies are organizations appointed by the European Commission to assess whether a product meets specific regulatory standards.

In 2013, the European Commission (EC) passed a recommendation that all device manufacturers under the Active Implantable Device Directive (AIMDD), Medical Device Directive (MDD), or In Vitro Diagnostic Device Directive (IVDD) are subject to unannounced audits. These companies must also identify and give the names of all critical raw material and component suppliers to the NB.

During the audit, NBs inspect quality and compliance records for both the device manufacturers and their suppliers. NBs will then analyze and determine whether these products meet established industry standards, and submit their findings to the EC. NBs face heavier fines than manufacturers, if harmful devices make it to the marketplace, so it’s anticipated these audits will be extensive and rigorous.

What Is An Unannounced Audit?

Unannounced audits are simply that – audits occurring without prior notice. These checks are in addition to – not in lieu of – scheduled audits where companies have a few days’ or few weeks’ notice.

Companies selected for audit must provide full access to their manufacturing processes, as well as quality, batch, and purchasing records. Medical device manufacturers, their CRITICAL suppliers, or their subcontractors selling products and/or services must comply.

Manufacturers must also absorb all audit costs, including device acquisition, testing, travel, and lodging expenses.

Under the EC recommendation, NBs conduct unannounced audits at least every three years. At least two auditors must be present, and the audit must last at least one full day. For companies producing more products, audits could take longer. If a device is deemed high risk or if there’s a question of non-compliance or non-conformity to industry regulations, audits could occur more frequently.

Why Is This Happening?

In 2010, French breast implant manufacturer Poly Implant Prothèse (PIP) was exposed and fined for using industrial-grade silicon instead of medical-grade in its products. A report from the United Kingdom found, in 2012, that industrial-grade implants are twice as likely to rupture, leaking silicon into the breast. The ruptures caused scar tissue, pain, inflammation, or change the shape and feel of the breast.

Approximately 300,000 women received PIP implants, and those who suffered leakage received €3,000 – roughly $3,400 – each. European courts ordered both PIP and the German firm that granted the implants’ safety certificates to pay the compensation totaling nearly €6 billion.1

To avoid future scandals, the EC passed a recommendation that all IVD and medical device manufacturers must submit to NB-conducted unannounced audits.

The Goal & Challenges

The intent of unannounced audits is to ensure manufacturers continually and consistently comply with all quality management requirements, and NBs expect companies to be prepared. Arriving without warning gives auditors a more realistic reflection of a company’s day-to-day compliance and activities.

Zero-warning audits have challenges, however. Key employees might be unavailable or auditors could arrive when products aren’t being manufactured. All employees must understand unannounced audits will occur, and they must know how to contact quality management and production personnel at all times. Turning away auditors or any failure to comply jeopardizes a company’s certification.

The European Union and and European Free Trade Association member states have authorized over 1800 notified bodies. Approximately 63 of these notified bodies are specific to one or more of directives associated with this commission recommendation. These bodies cannot actually enforce their recommendations, but they can report all audit findings to the EC who then imposes the necessary changes upon the manufacturer. NBs are liable, alongside manufacturers, for any audited product that enters the marketplace and causes harm, which is why these audits can be invasive and detailed. It is in the manufacturer’s best interest to fully cooperate in order to maintain certification.

How Do You Prepare?

To be ready for unannounced audits, manufacturers should develop and implement concrete plans to ensure these events run smoothly. Manufacturers must educate their suppliers and subcontractors that any problems during an audit can pose a risk to compliance certificates. Running mock audits to identify possible weaknesses in compliance and production processes could be helpful.

Most importantly, manufacturers should review and revise existing quality contracts – or create new ones – with their CRITICAL raw material suppliers and subcontractors. At minimum, contracts must ensure auditors won’t be turned away and will receive full access to the production chain and pertinent records.

Some questions you could be asking your suppliers to ensure they have the correct quality policies in place and are prepared for unannounced audits are:

  • As a crucial supplier of critical materials used in a medical device, are you aware of the EU directives requiring unannounced audits by Notified Body of your facilities?
  • As a crucial supplier are you willing to enter into a Quality Agreement or contract permitting these unannounced audits?
  • What quality policies do you currently have in place that would prepare you for an unannounced audit?
  • The materials we obtain from you could be considered a critical component in our products, therefore making you subject to an unannounced audit. Are you aware of this?
  • What measures are you taking to ensure complete supply chain transparency?
  • Costs associated with unannounced audits are covered by the medical device manufacturer and not the crucial supplier; will this further facilitate your willingness to accept these audits?

To be most effective however, suppliers and subcontractors must do more than merely open their doors to NB auditors. They must actively take steps to help manufacturers consistently meet regulatory requirements.

How Sigma-Aldrich Can Help

As a CRITICAL raw material and component supplier to the diagnostic and medical device industries, Sigma-Aldrich understands the need for supply chain transparency, critical control parameters in manufacturing and a documented manufacturing process that has stringent quality control procedures. We recognize the importance of these unannounced audits, and we’re ready to partner with you and help you prepare. Our teams of over 2,000 quality and supply chain professionals have established best-in-class programs to ensure quality compliance and effective supply-chain management.

As part of the Enhanced Quality Program, Sigma-Aldrich offers quality levels. The highest two levels in this program, Elite and cGMP, are well aligned and have the proper controls needed to comply with the regulatory guidelines for diagnostic and medical device manufacturing. Products in these groups come with complete supply chain documentation, change control notification and recommended product use, allowing the manufacturer to feel confident they have mitigated any supply chain risk or disruption. Sigma-Aldrich works in partnership with our diagnostic manufacturing customers to make sure regularly-used products are continuously being upgraded to Elite and cGMP for commercial manufacturing use.

For an additional level of security, Sigma-Aldrich will now offer quality agreement policies for companies purchasing Elite and cGMP products, which include specific support for unannounced audits. These policies will ensure the manufacturer's compliance within the ever-changing regulatory environment. Interested manufacturers can contact Sigma-Aldrich directly or at qualityservices@sial.com to inquire about establishing these agreements.

You can count on Sigma-Aldrich for high-quality and safe raw materials that fit your every diagnostic manufacturing need. Our company has extensive experience with inspections conducted without advance notifications and is ready to handle these types of audits from NBs. You can confidently consider us as an extension of your own quality systems and programs.