When it comes to identifying and controlling nonconforming product, place significant emphasis on the need for a robust system, premised on well-written procedures. It is always a bad thing for nonconforming product to find its way into the supply chain.
Compilation of the Seihin Hyojun Sho or the Device Master File is a necessary evil for device manufacturers wanting to introduce product into the Japanese market.
The responsible engineering manager’s role is unique. A scripted procedure is recommended that clearly delineates the responsibilities as they pertain to MO 169 and Articles 65, 68, 70, and 71. It is also considered a best practice to identify the role of the responsible engineering manager on an organization chart and document the role through the use of a letter of delegation.
Be proactive and create just one procedure for corrective action and preventive action (CAPA). Medical device manufacturers must actually pursue PA and have documented evidence of their efforts. After all, if PA is not documented in writing, it never happened.
A corrective action procedure requires a significant amount of intelligent thought to ensure all aspects required of an effective corrective action process are captured. Plan ahead and incorporate the preventive action requirements (Article 64) into the corrective action procedure; thus, creating a CAPA procedure.
Make sure that the procedure scripted by your organization addresses all of the requirements associated with “Improvement” (Article 62). Since most medical device manufacturers get the complaint management piece right, let’s focus on what is often missed.
Do not be that organization that gets stuck buying green catheter handles, when the requirement is for white. Article 61 does not tell device manufacturers what data needs to be collected and analyzed. It is completely up to each organization to decide. Remember, your organization, your data, so you decide what data is important.
The control of nonconforming product should never be an onerous task. Keep it simple by never allowing non-conforming product to make its way into your organization’s supply chain. While UAI is convenient, eventually the use of such concessions is going to break your heart.
It is not enough for device manufacturers to simply clone a QMS or develop procedures employed for device manufacturing. Manufacturers must be able to gauge the effectiveness of their policies, procedures and processes, and provide objective evidence that their approach to quality and the manufacturing of devices is effective.
Internal audits, regardless of the regulatory environment, are a fundamental requirement for an effective QMS. ISO 13485:2012; 21 CFR, Part 820, and MO 169, each clearly specifies that device manufacturers must plan and perform internal quality audits in order to gauge the overall effectiveness of the QMS.
