Re: Audit found Form with Identical Contents but different Format - is this an NC?
How so?
In the early days of word processing software, people would change fonts in forms just because they like to experience/play or just because they could.
Some sophisticated forms provide acceptance criteria, but, for the most part, the intent of a form is to capture data/results of an activity. If different formats of a form (for example, what Marc said about exhausting previous versions of a form, before using a new one) capture all the required data, I don't see how critical the issue would be. As Andy mentioned, the concept of identifying a potential nonconformity, categorizing and reporting it, should go through a brief and mental risk assessment. I see very little risk in two operators using two dissimilar forms, once again, if they capture all the necessary data and results. After all, the content, not the format, is important.
I also second Andy's comment about auditors focusing excessively on documents and records. Unfortunately, auditors tend to go to their comfort zones during an audit, zooming into less subjective issues. To this date, document control is one of the most written up sections of the QMS standards. Why is that? Simply because it is very easy to audit for, the number of opportunities for problems is high and auditors like "black and white" scenarios because there is very little arguing if the master list calls for Rev. E as the current one for a document and the technician is using Rev. C, it is a clear failure.
Auditors tend to shy away from process and areas that they are not comfortable with, especially top management.
If a form is revision controlled, everybody should be using the proper version, but categorizing a finding as a nonconformity, especially a major one, should take into account risks and impacts of the evidence at hand. In this particular case, based on the information we have at hand, I would be hard pressed to consider the situation a detriment to the QMS.
If you are allowing two separate formats to be used in your organization, you are openening yourselves up for some real trouble.
In the early days of word processing software, people would change fonts in forms just because they like to experience/play or just because they could.
Some sophisticated forms provide acceptance criteria, but, for the most part, the intent of a form is to capture data/results of an activity. If different formats of a form (for example, what Marc said about exhausting previous versions of a form, before using a new one) capture all the required data, I don't see how critical the issue would be. As Andy mentioned, the concept of identifying a potential nonconformity, categorizing and reporting it, should go through a brief and mental risk assessment. I see very little risk in two operators using two dissimilar forms, once again, if they capture all the necessary data and results. After all, the content, not the format, is important.
I also second Andy's comment about auditors focusing excessively on documents and records. Unfortunately, auditors tend to go to their comfort zones during an audit, zooming into less subjective issues. To this date, document control is one of the most written up sections of the QMS standards. Why is that? Simply because it is very easy to audit for, the number of opportunities for problems is high and auditors like "black and white" scenarios because there is very little arguing if the master list calls for Rev. E as the current one for a document and the technician is using Rev. C, it is a clear failure.
Auditors tend to shy away from process and areas that they are not comfortable with, especially top management.
If a form is revision controlled, everybody should be using the proper version, but categorizing a finding as a nonconformity, especially a major one, should take into account risks and impacts of the evidence at hand. In this particular case, based on the information we have at hand, I would be hard pressed to consider the situation a detriment to the QMS.
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