Thanks! You've successfully subscribed to the BONEZONE®/OMTEC® Monthly eNewsletter!

Please take a moment to tell us more about yourself and help us keep unwanted emails out of your inbox.

Choose one or more mailing lists:
BONEZONE/OMTEC Monthly eNewsletter
OMTEC Conference Updates
Advertising/Sponsorship Opportunities
Exhibiting Opportunities
* Indicates a required field.

What if Your ISO Auditor is Wrong?

Imagine completing your first ISO Certification audit. Your company received no major nonconformities, but the auditor identified a bunch of minor findings. You expect to receive a recommendation for certification, but instead the auditor says, “There were eight minor nonconformities, and therefore I cannot recommend certification.”

The auditor is explaining that they never recommend certification if there are more than seven minors in an audit. “What!?” you reply, “You never said anything about a maximum number of minor nonconformities. You said that we would be recommended for certification if we did not receive any major nonconformities.”

More than one company has heard something like this before—and the auditor was wrong. Auditors are human. The question is: What should you do when your auditor is wrong?

In this situation, there are three things you should know:

  1. Audit findings are not a jail sentence.
  2. There is an appeal process.
  3. You can and should push back.

Worst Case Scenario
You, and your boss, need to remember that the worst that can happen is that you receive a nonconformity. If the auditor finds a nonconformity, then you need to develop a CAPA plan. If the auditor finds nothing, one of the guides probably noticed a nonconformity that the auditor overlooked. Regardless of the number of findings, there is no pass or fail in audits. There is always something you need to improve.

If you do receive a dreaded major nonconformity, what happens? You write a CAPA plan. There are three practical differences between a minor and major finding. First, you now have to pay for a special audit to close or “knock-down” the finding from major to minor. The approximate cost of a one-day special audit is $2,000.

Second, you typically have a maximum of 90 days to implement corrections and begin implementing your corrective action or actions. Major findings require immediate correction and aggressive corrective actions. This probably means that you will be taking some work home with you next month, or putting other routine activities on hold.

Third, everyone’s perception is that major findings are a big deal. I think of them like a speeding ticket. If you received a major, you probably already knew you were not in compliance (“Yes officer, I was driving 65 mph in a 50 MPH zone.”). If you did not know, there are two possible reasons: #1, your internal audits are wimpy, or #2, you need training.

The Appeal Process
A client should never be surprised by the audit’s outcome. If they are, the auditor did not communicate findings clearly during the audit or did not communicate the process clearly during the opening meeting. Of the two, poor communication during the opening meeting is the more common.

ISO 19011:2011 is the official guidance document for auditors of Quality Management Systems. Section 6.4.2 of this standard explains the best practices for an opening meeting. The last five items in this section are critical to preparing the client for potential non-conformities:

  1. The method of reporting audit findings, including grading, if any
  2. The conditions under which the audit may be terminated
  3. Time and place of the closing meeting
  4. The way to deal with possible findings during the audit
  5. The system for feedback from the auditee on the findings or conclusions of the audit
  6. The process for complaints and appeals

4 COMMENTS

Security code
Refresh