Defining Major vs. Minor Changes to Procedures

T

TigerLilie

We define major changes to a procedure as something that alters the form, fit or, function, such as a change in process. In this case, procedures must be up rev'ed. Minor Changes, such as spelling or grammar do not require an up rev.

We have a policy embedded in a manual and when the Company changed CEOs, I changed the name on the policy to the new CEO but did not up rev because there was no material change in the process. I viewed it as a minor change.

Thoughts?
 
Q

qualityfox

I avoid specific names in procedures like the plague. I call out job title only. Although these can change also, it's still better than a specific name because I can usually talk my way around a job title with an auditor.
 
I do something similar, but the change, even if it is just a review of the procedure, is noted in the revision page, I just do not update the rev number or date. I periodically review all of the procedures and they are noted in the matrix in the front, just to make it easy for others to know "I was there".
So, yes, I sometimes do not change the rev level and date for minor changes, corrections, or even additions if it simply a clarification.
But Every access to the document is noted, even if nothing changes.
 

Mark Meer

Trusted Information Resource
As far a procedure changes, because there is no particular requirement to distinguish between "major" and "minor" (or any other such categorizations), how you handle it is purely up to you.

In our system, if it's changed it's a new revision.
While there is no explicit distinction between "major" and "minor" changes, there are a bunch of decisions within the change process that define a spectrum of significance. For example does the change require training/re-training, verification and/or validation, supplier/customer/regulatory notifications...and so on. No to all = minor change.

Though I have often considered a major/minor revision level system (e.g. a minor change to "revision 1.1" would be "revision 1.2", and personnel are allowed to use any "1.x" document as the differences between them are deemed inconsequential (spelling/grammar/formatting corrections). ...but why complicate things, right?

Personally, I keep track of "minor" things such as spelling or grammar and queue them to be included in future revisions. ...no point processing changes that are not going to actually make any tangible improvements.
 

John Broomfield

Leader
Super Moderator
We define major changes to a procedure as something that alters the form, fit or, function, such as a change in process. In this case, procedures must be up rev'ed. Minor Changes, such as spelling or grammar do not require an up rev.

We have a policy embedded in a manual and when the Company changed CEOs, I changed the name on the policy to the new CEO but did not up rev because there was no material change in the process. I viewed it as a minor change.

Thoughts?

TigerLilie,

I agree with the way you have defined major and minor changes and with the way you have used this definition.

John
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
I also support major and minor changes, in my last employer the criteria were similar. We called these minor changes "administrative change" and made a note in the revision change block without uprev or a need for full signature loop.
 

Mark Meer

Trusted Information Resource
While I appreciate how it could be of use, my reservations on implementing a major/minor change system as described are as follows:

  1. How necessary are these "minor" changes? If, for example, the spelling and grammar are so atrocious that management declares a change is necessary, then there's probably a problem at the review/approval stage. If it's just a few minor spelling mistakes that don't have any effect, it seems like it'd be simpler just to make note and include them in a future ("major") revision.
  2. The unnecessary complication of change process. Essentially, you are defining another category of change which is handled differently. While this doesn't necessarily double the complexity, it does inject a bunch of "if"s, "but"s and "unless"s into your process.
  3. The "gray" areas. For example, does the formatting change affect the legibility? Do the grammatical errors cause confusion? These are cases where the changes may appear minor, but in fact are affecting their use.

I'm sure there are ways to overcome these, and that many companies have an effective system for major/minor changes. ...but my advice would be to carefully weight the value/benefits of a major/minor change system against the potential administrative costs of implementing and maintaining it...
 
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Jen Kirley

Quality and Auditing Expert
Leader
Admin
Administrative changes should be used with care to ensure the document's understandability is not changed. It's true they can mask or enable poor grammar, but that can be approached independently after the document gets fixed.

Sometimes I see administrative changes done to fix pagination, add revision numbers to each page, change the logo in the header if the company is acquired, correct misspellings, even to fix hyperlinks if document control software prevents checking out and in without evidence of having done so. Adding a note explaining the change in a revision block or comment in the software helps provide the traceability these processes need to stay credible.
 
Our external auditors frequently ask for these, I in the past I have gotten comments to the effect "I see this has not been updated in a few years...".
Now I log every revision, no matter how minor on the revision page, keeping the same version number and date, but adding a note explaining what was done. I have found that adding this note when I review the procedure for any reason, even without any changes at all, at least shows that it is actively being looked at at.
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
Our external auditors frequently ask for these, I in the past I have gotten comments to the effect "I see this has not been updated in a few years...".
Now I log every revision, no matter how minor on the revision page, keeping the same version number and date, but adding a note explaining what was done. I have found that adding this note when I review the procedure for any reason, even without any changes at all, at least shows that it is actively being looked at at.
It is a good practice to log a periodic review, even if nothing changes. :agree1:
 
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