One thing I found interesting was the difference between quality assurance and quality control. Quality assurance is more preventive and focuses on the methods and systems used to make sure a product meets requirements, while quality control evaluates the results against acceptance criteria to determine whether something should be accepted or rejected. I think having both is important because finding a problem after a product is finished is different from preventing the problem from happening in the first place. Why do you think companies might sometimes focus more on quality control instead of preventing problems through quality assurance?
A lot of companies are resistant to QA‚ but QC has a pretty immediate payback: You inspect a batch and you can point to a defect rate going down․ But QA is much harder to "see" working․ If I spend more time in the design phase on process‚ or training‚ or on risk management up front‚ the reward for that is problems that don't happen‚ and I can't measure the cost of a problem that didn't happen․ So in a cost-cutting atmosphere‚ QA was always a harder sell․ Because the people who make the budget want a number․ "We prevented a defect that would have happened" doesn't hold water‚ but "We caught 200 defective units before they shipped" does․ And there's the timing problem․ QC is naturally part of a manufacturing schedule‚ because you make a product and then you test it․ QA activities‚ like process validation‚ design reviews and investigations into corrective actions and preventive actions (CAPA) tend to take longer to show results and are often at odds with the production schedule․ It seems easy to treat QC as a fallback when we're under pressure to ship‚ and to deprioritize the QA activities that would have helped prevent the issue in the first place․ I think this is one of the fundamental tensions in the medical device world between the outputs generated in the short term and the risk management required in the long term․ Even when a company passes every quality control (QC) inspection‚ it may still be compelled to issue a recall as a result of a systemic design error․ This is why regulations like 21 CFR 820 (QSR) and ISO 13485 explore the quality assurance (QA) issues of design controls and CAPA‚ beyond final inspection․