There are just a few areas that QMS auditor or FDA focuses to find out if a firm follows a system of continuous improvement. These areas include inventory, calibrations, deviations and CAPA system. Warning letter issued by FDA usually contain abundance of examples indicating how firms fail to follow their own deviation and CAPA systems. Question is: why do manufacturers fail to carry out meaningful deviation investigations? Principles of CAPA and analysis of various sources and FDA warning letters point to the following main points.
- Product being manufactured is not grounded in quality by design (QbD), meaning R&D did not develop and optimize processes by keeping the final goal in mind. Perhaps their main focus was to beat the competitor in filing IND submission to FDA. In that scenario the critical activity of continuous improvement, falls completely in the jurisdiction of manufacturing department.
- In general deviations would occur any way regardless of problems at R&D stage of a products’ life cycle. But the issue becomes complicated when open deviations are not closed properly and on a timely basis. In many cases departments only start to pay attentions to deviations when it’s time to release a product batch. At that stage the proper information and scientific facts to close the investigation may be missing, as a result of which either release of the product will be delayed or investigation is closed without the detection of real cause of the deviation!
- To reach the bottom of the root causes a broader focus of an investigation is required that may extend to more than one batch of product. For example an investigation on the contamination of a product that utilizes open vessel mixing may not be closed by evaluation of one batch only. If a batch of such product got contamination from rust or blistering paint of mixing equipment that problem is likely to extend to multiple batches. So an investigation narrow in scope will not serve any meaningful purpose.
In summary to mitigate the problem of mishandling deviations and CAPA and to avoid warning letters and 483s, firm should keep their focus of investigations broader. Furthermore use of multiple methodologies of root cause analysis rather than single method would be beneficial. For example utilizing just 5 whys method may not be adequate strategy to strive for continuous QMS improvement. Fishbone diagram, brain storming, input from subject matter experts of differ deportments are likely to produce a better resolution and mitigation of problem, moving the firm towards continuous improvement.
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