ISO 9001:2015 – Newsletter – Issue 138

Issue 138 – Do blank Forms need to be reviewed the same way that Procedures do?

ISO 9001:2015…

Do blank Forms need to be reviewed the same way that Procedures do?

I appreciate receiving emails with questions and/or comments from readers of this Newsletter… please continue to do so since it provides me with ideas on what these publications should cover.  In my last Newsletter (ISO 9001:2015 Newsletter Issue 137) we discussed the topic of  “Do you need to audit all Processes/ISO Clauses at least once per year?”, and now in this Newsletter we will discuss “Do blank Forms need to be reviewed the same way that Procedures do?”.

The ISO 9001:2015 Element numbering…

Element 4 – Context of the organization
Element 5 – Leadership
Element 6 – Planning
Element 7 – Support
Element 8 – Operation
Element 9 – Performance evaluation
Element 10 – Improvement

Do blank Forms need to be reviewed the same way that Procedures do?… This topic came up during a recent audit because I had noticed that some of the forms being used by the company had very old revision dates on them, with some well over a decade since they were last revised.  I was advised that all “forms” had no formal “review cycle” associated with any of them, and that they are informally reviewed by the person filling them out, and that they would request a change to the form when needed.

I decided to take a random sample of one older form and asked to see examples of some recently completed ones.  I scanned approximately 50 or 60 examples and noticed that in multiple instances that certain required fields in the top portion of the form had been left blank while the whole bottom third of EVERY form was completely blank and the only reason offered was that the bottom is never filled out.

What options does the Auditor have when Forms are not regularly reviewed?… On the face of it, not reviewing Forms at some predetermined frequency is not necessarily a problem for ISO 9001… however the Standard certainly expects you to “control” your blank forms by giving them a unique Doc# (or a unique title/name), as well as a Rev Level/Date.

However having a form that is not up-to-date or doesn’t reflect the activity being recorded is probably not a good business practice.   Why?… because as in the example described in the above paragraph, you could end up confusing the employee who is responsible for filling it out, by telling them to ignore certain portions of this particular form… and to ignore other portions on other different forms, etc, etc… especially if this employee is a “trainee” trying to do the right thing.  I understand the push-back of having to periodically review blank forms since it’s hard enough just to keep up with regularly reviewing all of their Procedures.

Another approach would be to ask: “Who looks at all of these filled out Forms?”  Should they be looked at?  First of all, since we are using company time to fill out these forms we probably should make sure they actually are being filled out properly.  Secondly, if the person who is reviewing the completed forms notices that certain essential information is NOT being regularly collected shouldn’t that be a problem?  BTW, I’ve been known to issue a nonconformance for fields on forms that are NOT filled in (if they are required fields).  Thirdly, if the person reviewing the completed forms notices that a section is always left blank for a whole year, and that’s acceptable, then why not submit a request to revise that form?  In the example described in the first section above, to let it continue for 10+ years just says you don’t care.

If you decide that you are not going to formally review blank forms on some periodic basis, then my recommendation would be to add a paragraph in your Document Control Procedure that says that if after a year, if certain sections/fields of forms are no longer needed, then a revision to that document will be initiated… this at least will attempt to inject some operational discipline into the organization when it comes to completing paperwork (…and may also keep External Auditors from writing this up).