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Planning for the Unpredictability of Change

...and it Begins


Change, defined: The act, process, or result of altering or modifying

Change is inevitable and sometimes even predictable but, then again, that depends. If you’re an orthopaedic device company obligated to follow the edicts of 21 CFR, Part 820 and ISO 13485:2003, the frequency of change is directly aligned with the complexity of your Quality Management System (QMS). Also, the classification of the medical device being designed, manufactured or serviced, the maturity of your systems and the robustness of process control can also have a huge impact on change. What makes it complicated is that these examples of the parameters of change commonly happen in concert rather than in solo. Companies that are not ready for that dynamic can struggle day-in and day-out with a brand of motivation that can be unpredictable and sometimes damaging to compliance initiatives. Change can actually put a company on its heels, especially if these changes are not planned for.


This article cannot do justice to all of the possible changes that can occur in a typical QMS because of company variability and systems’ latitudes. Also, the number and types of changes could be the subject for a substantive volume of work. This article is just an overview that will focus on the changes associated with document control, design and development and purchasing controls. All are hot buttons in the regulated orthopaedic industry that we live in every day.


Document Control Changes

The most common changes that your QMS could experience lie in the areas of document controls. These changes should be reviewed and approved by an individual with the established responsibility and authority to obviate the chance of issuing inaccurate policies, procedures or work-instructions. Single-handedly, the Good Manufacturing Practice Regulations for medical devices require at least 90 to 100 different types of records (objective evidence) to be generated depending upon the scope and process/product risks involved. Records are generated because of procedural demands. If these procedures are frequently changing, for whatever reasons, the outputs will change accordingly. Conversely, if the outputs (process or product) must be revised to enable system compliance, that could place a lot more emphasis on the ramifications of changing for the wrong reasons. Each manufacturer shall maintain records of changes to documents. Change records shall include a description of the change, identification of the affected documents, the signature of the approving individual(s), the approval date and when the change becomes effective.


For a more mature QMS, a change control procedure is one of a series of standard operating procedures (SOPs) used to produce and control documents or activities that result in record keeping. This procedure should contain an appropriate degree of flexibility. That is, all changes do not need the same degree of evaluation and approval. Changes that do not receive the necessary evaluation and review could result in hazardous or ineffective devices, as exemplified further into the process. It is never direct root cause. Change dynamics are sometimes masked by process innuendo. Making uncontrolled changes is considered a violation. 21 CFR, Part 820 is a flexible Regulation which allows manufacturers to develop and use procedures that meet specified needs. These are usually established during the design control process, or when a QMS is being constructed.