Are FDA inspectors good?

When the author witnessed an FDA inspection at a certain listed company, the president of the company asked the following question at a preliminary meeting. “Are FDA inspectors that good? Will quality really improve if we follow the FDA inspectors’ suggestions? FDA inspectors don’t manufacture drugs, and they don’t design and manufacture medical devices.” You are right to wonder.
However. Inspectors from the authorities and consultants like us who conduct audits have inspected the QMS of many companies and We have inspected the QMSs of many companies.
This is why benchmarking (comparison) is possible.
In other words, if a company is not doing what other companies are doing, it is a risk.
In addition, deviations or collection cases that have occurred at other companies, if the company in question is not aware of them, would still be a risk.

Thus, inspections and audits are meaningful in identifying risks.

Often the author sees cases where the audit only points out past mistakes or problems.
Of course they are important. However, past mistakes and problems should be resolved by QC and QA, not by auditing.
An audit is not to find problems, but to confirm that there are no problems.

As noted above, the audit must uncover risks.
However, it is probably impossible to spot the risk with a raw employee.
This is because they do not know how other companies do things.
Because they are “right” with the way they are doing things, they are unaware of shortcomings and dangers.

Many companies follow an audit checklist to conduct audits and look for problems.
In addition, only group training is provided for auditors.
This is no way to compete with inspectors with a hundred years of experience.
So how can we train auditors?
It is to perform supplier audits and gain experience.
In doing so, we should not audit only companies with poor quality, but also good quality
Benchmarking is possible through a number of occasions.
It is impossible for a frog in a well to point out its own risks like an FDA inspector.

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