Common Quality System Challenges: Document Change Control

Posted on: June 6, 2018

One of the challenges for medical device companies, especially startups, is reviewing, approving, and implementing changes effectively as part of the Quality Management System.  Startup companies have varying degrees of knowledge and experience with Quality Management Systems.  The following are some of the common hurdles to overcome when meeting Document Change Control requirements whether it is FDA or ISO 13485:

  • Will the change justification meet Quality and Regulatory requirements?

To write an understandable and supportive justification takes time and thought.  When changes are urgent and the team driving the change is overloaded and being pressured, then the language for the change ends up incomplete.  It is important to remember that the quality of your product is dependent on the quality of the documentation.  Therefore, it is better to spend the time and get the documentation as good as it needs to be to meet the risks of the product.

  • Was there a proper “where used” done to make sure all affected parts and documents are being addressed?

A common mistake is to use memory or an internal “expert” on which parts and documents are affected.  A system is needed to ensure consistency.  The system can be electronic or paper, but it should ensure that everyone can search the same way and get the same results.

  • Have training requirements been properly captured and completed prior to closing the change order?

Everyone understands the importance of training, especially for new employees.  It becomes a bit difficult to assess and execute training for changes. The extent and significance of the changes will determine the training requirements, and the training matrix can help determine who needs to be trained.  Rewarding and recognizing employees who are regularly meeting new training requests is a great way to encourage others to follow suit.

  • How do you make sure the change is assessed properly? Do you rely on the memory of the reviewers, or have detailed procedures and checklists?

Sometimes what appears to be a minor change to a component or process can have significant repercussions to the design of other components or subassemblies, production processes, or the suppliers who produce the part.  It is very helpful to have a checklist of questions as part of your change order process to confirm the change is assessed and properly qualified / implemented.

  • Are materials properly dispositioned and suppliers notified of changes?

When part numbers are changed, it is easy to lose track of inventory related to that part.  Typically, the materials department gets involved to help decide how to handle the materials in the pipeline from raw materials to finished goods.  This will be determined by the significance of the change.  If the part is made by a supplier, the purchasing department or document control can send the updated specifications and provide direction on what to do with inventory in progress or already produced.

  • Does the completed form meet Good Documentation Practices (GDP), especially if done on paper?

Blank spaces or incomplete fields on the change order form are common, as well as changes made without traceability of who made the change.  Thorough review helps reduce these errors, but creating a user friendly form that allows users to add rows as needed, or use “N/A” boxes can make it more intuitive to prevent these type of documentation errors.

Clearly, a lot of things can go wrong with what would seem to be a relatively simple process.  Monitoring Change Control performance through auditing by your Document Control specialists and tracking the quality of each change order is a great tool to help improve the Change Control process.  In addition, the results can be shared during Management Review to show the effectiveness of this process.

Contributed by Vee Arya, a Quality Director at Cannon Quality Group with over 25 years in medical device experience in all aspects of quality leadership and support (Quality Strategy and Objectives, Design Control, Production Support, Process Validation, Complaints, CAPA, NCRs, Supplier Management, Management Review, etc.)

Cannon Quality Group provides outsourced Quality Management System solutions to startup medical device companies that are engineer focused and compliant. Cannon’s number one priority is delivering QMS solutions that make sense for the stage and goals of its clients’ business. Cannon Quality Group’s mission is to be the Change in


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