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Develop Orthopaedic Implants Faster Through Auditing

Most auditors pretend to “add value.” Adding value is a cliché. In this article, you will learn three auditing techniques that actually improve product development (or any process). The first tool is a simple auditing technique that most auditors know, but forget to use. The second is an advanced technique that auditors don’t always learn. The third tool is probably completely new to auditors.

Tool #1: Open-ended Questions (Simple)

Most auditors use an audit checklist with questions like:

  1. Do you have a Design Controls procedure?
  2. Did you document your design plan?
  3. Is your team trained on risk management?

Unfortunately, this checkbox mentality will not help you find ways to get new products to market faster.

The three questions above are closed questions—they are questions that require simply a yes/no response. Internal auditors from the Quality department ask these questions because they are focusing on regulatory compliance instead of improving a process.

Better audit questions would be:

  1. How do you know what steps to follow when designing a new implant?
  2. Which verification tests are required for implant wear resistance?
  3. Who participated in the risk analysis of your new bone screw?

These three questions are open-ended questions—they require more than a yes/no response. Asking open-ended questions encourages the process owner who is being interviewed to share additional information needed to identify opportunities for improvement. The key to successful use of this technique is using it consistently. It must become a habit.

Tool #2: Turtle Diagrams (Advanced)

Most auditors confuse the “process approach” with “auditing a process.” In product development, specific regulatory requirements exist for that process (i.e., Design Controls). In 2012, Design Control deficiencies were the most common reasons for issuance of a 483 violation by FDA after an inspection. A company can receive a 483 for Design Control deficiencies for three different reasons:

  1. Nonconformity of Intent: This means that your Design Control procedure is missing one or more of the requirements of the regulations. However, if an experienced auditor does a thorough job of auditing the procedure against the requirements of ISO 13485 and 21 CFR 820 before initial approval of the procedure, then the procedure should meet the intent of the regulations. If this has never been done, it should be done now. This can also be performed as a remote desktop audit by a consultant.
  2. Nonconformity of Implementation: This means that your Design Control procedure is not missing any requirements, but you have not followed part of your own procedure. This is probably the most common finding, because there is not a diligent review of the procedure by the process owner to make sure it matches the way that things are actually done. This is likely to happen when someone other than the process owner writes the procedure, or the procedure has not been updated in several years.
  3. Nonconformity of Effectiveness: This means that you have performed your procedure as written, but for some reason the process is still not achieving the intent. This is the most challenging type of nonconformity to find, and the root cause is typically related to ineffective process interactions. In this case, using the process approach to auditing provides the greatest benefit.

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