OFI’s, or “opportunities for improvement”, in an ISO9001-2008 quality system.

During an ISO9001-2008 quality system audit, it’s fairly common for an auditor to write up “OFI’s”, or opportunities for improvement. These are really just suggestions, usually meant to help you improve your quality system, at least in the auditor’s mind.

OFI’s can be written during an internal audit, or a third-party audit. I tend to believe many more are written during third-party audits, as those auditors are professionals and tend to do such things. Internal audits tend to be people who work for the company, normally doing their regular jobs, only occasionally acting as auditor, and not really wanting to be bothered by writing up suggestions that will likely fall on deaf ears.

So let’s say that, during your registration or surveillance audit, the auditor writes you up some OFI’s. Should you act on them? Keep in mind that, when it comes to ISO9001-2008, there is the letter of the law and the spirit of the law. Chances are that if you’ve screwed up on a “letter of the law” matter, the auditor will have written up a major or minor nonconformance. The “spirit of the law” is often subjective, and while the auditor probably means well, the opportunity for improvement that is presented is merely his/her recommendation. If you honestly feel that what the auditor is suggesting will truly improve your operation, then by all means go ahead and implement it.

However, if you find yourself scratching your head a lot after reading the OFI, maybe it’s best to just ignore it.

I was in the commercial aircraft parts industry for many years, and often dealt with the Federal Aviation Administration. Some said that “there is not one FAA, there are hundreds of FAA’s”. After dealing with the FAA on numerous issues, that became my mantra. Every FAA representative had his/her own take on a particular regulation, and it was not uncommon to be told something was white one day, and black the next. The ISO9001-2008 quality standard is pretty much the same.

Keep in mind that professional auditors are looking at your audit from their point of view, which may not coincide with your viewpoint. Maybe the auditor wants you to add a bunch of documents to your quality system, or wants you to increase your internal audit frequency to the point that it becomes a burden. Don’t just roll over and go along with the OFI if it doesn’t make sense to you. Read the ISO9001-2008 quality standard and see if you meet the letter of the law. Professional auditors may give you some OFI’s not even considering the impact it will have on your business, and not taking into account the time it will take you and your people to implement and maintain the suggested course of action.

Like all things with ISO9001 audits, you do have to be prepared to defend your chosen course of action. It’s possible that your auditor will come back in a year, armed with his previous audit report, and ask why you did not implement his OFI. As long as the auditor is a reasonable person, and your chosen action (or inaction) can be logically defended, you’ll be fine. Although I suppose the auditor might suggest the same thing a second time.

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