![]() ![]() I have only had a couple of clients in the past decade that argued about the importance of preventive actions, but most clients ask me, “Where can we find more?” Guidance DocumentsĪs a certification auditor, I was not allowed to “consult,” but was able to mention guidance documents that might help. These companies often talk about the “Cost of Quality,” and when you tour their facility, you see quality objectives being communicated to everyone. These companies have strategically chosen to create their quality systems to a higher level of performance because they know that preventing quality problems results will cost substantially less than waiting until problems occur, and then fixing those problems. In order to find preventive actions, you have to develop your other quality system processes. ![]() No, the CAPA process is how you correct and prevent quality problems. There were a few companies that had more preventive actions than corrective actions, and the quality systems at those companies happened to be much stronger in general-not just their CAPA process. While I was conducting certification audits, I noticed that the better quality systems tended to have several examples of preventive actions. Many auditors will issue a nonconformity if you have no examples that are 100% preventive. Therefore, your ISO certification auditor will expect you to have at least some examples of CAPAs that are 100% preventive. ![]() The wording of the two clauses is nearly identical, but ISO certification auditors tend to be purists. Throughout the FDA QSR, corrective action and preventive action are always found together, while in the ISO Standards, preventive action is a separate clause (i.e., – Clause 8.5.3). Still, the approach to preventive actions is distinctly different between the ISO Quality System Standards (i.e., – ISO 9001 and ISO 13485) and FDA regulations (i.e., – 21 CFR 820.100). Most ISO auditors and FDA inspectors view CAPA as one of the most important processes in your quality system. The author discusses why preventive action is important in developing a sustainable and robust quality system and where to locate preventive action sources. Where to Locate Preventive Action Sources ![]()
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