![]() Classifying changes by impact and necessity Make it easy for employees to understand and use and they will become more engaged in the continuous improvement process. Dont make the change request form so onerous that employees take one look at it and run. Changes need to have a clear benefit and this needs to be articulated. There should also be space for the employee to justify why the change is needed. This should be an official form that allows space for the employee to make a clear and specific description of the proposed change including products affected and lot numbers if possible. So, whats the right way for an employee to float a proposed change? The first step seems obvious they need to submit an official request. Quality management system planning (5.4.2).Control of documents and records (4.2.4 and 4.2.5).21 CFR Part 820.70 (Production and process changes).The regulation and standard require that manufacturers establish written change control procedures that describe company approved procedures. The need for robust change control is outlined in three specific subparts of FDA 21 CFR Part 820 (aka, Quality System Regulation) and throughout ISO 13485:2016. US FDA and international regulations covering change control Make sure you file change documentation somewhere that other team members can find it easily if requested. Its very easy to slip into a bad habit of just making a quick change in an effort to be nimble but those shortcuts may come back to bite you when an FDA inspector or Notified Body asks to see the documentation. ![]() It is imperative that you have full management buy-in to this process. With regard to planned changes, it is important that you carefully document steps 1-3 above and have the appropriate management review and approve (step 4) any changes before making them. All employees must be trained to distinguish between a deviation and a change control request. ![]() ![]() Anything else is considered a deviation or nonconformity. There are few areas of the medical device design and manufacturing process that are not subject to change control procedures.Ĥ – Finalizethe change by securing management approvalsĦ – Communicatethe change to relevant partiesħ – Trainemployees affected by the changeĩ – Evaluatethe change and its effects Planned vs unplanned changesīy its very nature, a change control system covers planned changes. Change control procedures apply to all aspects of the device life cycle. A breakdown in the change control process can result in product recalls, regulatory penalties, negative publicity, and in extreme cases, injury or death to patients. If you have renewed any existing MDD CE certificates in advance of the EU Medical Device Regulation (MDR) going into effect in May 2021, youll want to read this post about what Article 120(3) of the MDR defines as a significant change that could jeopardize the validity of your MDD certificate.Īt its core, change control exists to prevent unintended consequences not create more paperwork. ![]()
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |