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A Quality Management System (QMS) is often designed well before a company starts the development of its product. A company wants to be prepared and will design the QMS first so as to develop said product properly and in accordance with regulatory standards, such as FDA standards. Establishing a practical and well-made QMS first can save a company a lot of time, money, and effort later down the line of development. However, it is not uncommon for practice to be different than theory. Once the QMS is actually being put to use the company may find that some processes, templates, or other aspects of the QMS need to be changed in order to fit their work better.

While it would be nice if changing an aspect of the QMS was as simple as making the change and moving on that is not the case. Change controls are required by most major regulatory bodies, including the FDA. The FDA outlines their change control requirements for medical devices in the 21 CFR Part 820.40.[1] Essentially, any changes to a document need to first be reviewed and approved before release, and the records of that change need to be documented as well. Now, the FDA does not explicitly state how they require a company to go about the review, approval, and documentation of changes process only that the process is a requirement. This means that a company is free to implement change controls in a manner that they desire so as long as it is consistent and meet the requirement. Other regulatory bodies, such as the EU, also require change controls, meaning that no matter what market a company is thinking about selling in they will have to have the process in place.  

Creating change forms, logs, and records of old versions of documents are all important aspects of change control. One important aspect of change control is a proper document numbering system for a QMS. If documents are numbered in such a way that the version number of the document is included it will be a simple matter to anyone familiar with the system that the version of the document they are looking at is not in fact the original version.

On the flip side, a poorly made change control system can leave gaps in a company’s QMS and lead to potential problems during an inspection or audit. EMMA International can help develop and establish a well-rounded change control system for a company, no matter what regulatory they need to meet. Additionally, EMMA International can help develop a company’s entire QMS, for QMS tips see this blog. From the start to the end and any changes that may be needed after EMMA International can help with it all. EMMA International provides Full Circle Consulting, give us a call at 248-987-4497 or email info@emmainternational.com to get in touch with our team of experts today.


[1] FDA (December 2021) eCFR Title 21, Retrieved 12/11/2021 from https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820/subpart-D/section-820.40

Gabe Kadoo

Gabe Kadoo

Mr. Kadoo is a Quality Engineer at EMMA International. He has experience in statistical analysis, performance improvement, quality assurance, and value stream mapping in the clinical setting. Mr. Kadoo also has experience as a clinical researcher and medical technologist. Mr. Kadoo holds a Bachelor of Science in Biology and a Master of Public Administration with a concentration in Healthcare Administration. He is also a Six Sigma Green Belt.

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