Clause 7.5.3 and Required Work Instructions

[Golfman25]

I'll keep the background as brief as possible while giving the details. We have a person who's sole responsibility is sorting parts. The have no autonomy and directed by their supervisor who instructs her when to sort, what to sort, how, etc. Most sorting is rather simple -- does the part have this feature or not (ie; a pierced hole) or maybe a cosmetic issue such as a scratch. So only verbal instructions are given. A small minority of time the sort may be more complex and part samples are used for reference, and every so often a picture is used if we don't have samples. But it is all directed and at the discretion of the supervisor. Like many manufacturing facilities we have a shop traveler which lays out the various production steps and includes a part print as an attachment. This is usually kept with the supervisor, unless and until needed somewhere else.

So last week, this person was subject to a third party audit. She did a great job answering the questions and was able to explain what she was looking for, show examples of good/bad parts, etc. Then she was asked about where to find the work instructions and of course could not because as far a she knew there where none as they where not given to her for this task (nor where they needed). The supervisor when asked indicated that a part print could be used if needed, but wasn't needed.

So we ended up with a non-conformance under 7.5.3 -- due to work instructions not available to operators.

Legit? Seems to me the auditor is projecting the need for documented work instructions where they are not needed. What say you? Thanks in advance.

 

[mattador78]

Surely thats subjective, the notes in 7.5.1 allow the organisation to determine what is required. We have to do a similar thing here if we barrel mixed jobs and ive never had any issues with it. Put one of them in that box and one of them in the other box until there are none left the barrel procedure here states to sort any items as required, as it changes every time you process a load as to whats in there.
7.5 Documented Information
7.5.1 General
The organization’s quality management system shall include:
a. documented information required by this International Standard;
b. documented information determined by the organization as being necessary for the effectiveness of the quality
management system.
NOTE: The extent of documented information for a quality management system can differ from one organization to another
due to:
the size of organization and its type of activities, processes, products, and services;
the complexity of processes and their interactions;
the competence of persons.

 

[Chrisx]

It seems like the nonconformity is written to the wrong clause. Perhaps, there is a reason that documented information is not applicable, but this reason would need to be documented. It would seem to be a nonconformity to 8.5.1:

The organization shall implement production and service provision under controlled conditions.
Controlled conditions shall include, as applicable:
a) the availability of documented information that defines:
1) the characteristics of the products to be produced, the services to be provided, or the activities
to be performed;
2) the results to be achieved;

 

[Randy]

So we ended up with a non-conformance under 7.5.3 -- due to work instructions not available to operators

This is a great, huge load of HORSE&HIT!

1st- Did a WI actually exist? YES or NO

2nd - Was there any probelm related to the unavailablity of the WI if it in fact did exist? YES or NO

3rd - Was all the work being done as required, when required and how required in the absence of the aformentioned nonavailable WI? YES or NO?

Here's the clincher about the "missing" WI .... 7.5.1 General...The organization’s quality management system shall include:...b) documented information determined by the organization as being necessary for the effectiveness of the quality management system.....NOTE The extent of documented information for a quality management system can differ from one organization to another due to:...— the competence of persons. (Just as stated by mattador78 above)

In the end, even if you do have a WI, 7.5.1 overrides 7.5.3 1st because you might have decided that a documented WI was not necessary & 2nd the person didn't need to do it because they had been "deemed competent".....Wanna have fun? Ask the auditor where his procedures and work instructions are for him to follow, that'll shut his yap............And yes to whatever Nay Sayer wants to bite that one, mine are on my laptop as well as ANAB Rules as well as some ISO Work Group stuff.

The only real times, other that when specifically required by the applicable standard, regulation or whatever, an auditor can drop a hammer on lack of documentation, is when lack of effectiveness or lack of control can be assigned, and even then it's dicey.

Appeal that knuckleheaded nonconformance if you choose.

 

[John Broomfield]

I'll keep the background as brief as possible while giving the details. We have a person who's sole responsibility is sorting parts. The have no autonomy and directed by their supervisor who instructs her when to sort, what to sort, how, etc. Most sorting is rather simple -- does the part have this feature or not (ie; a pierced hole) or maybe a cosmetic issue such as a scratch. So only verbal instructions are given. A small minority of time the sort may be more complex and part samples are used for reference, and every so often a picture is used if we don't have samples. But it is all directed and at the discretion of the supervisor. Like many manufacturing facilities we have a shop traveler which lays out the various production steps and includes a part print as an attachment. This is usually kept with the supervisor, unless and until needed somewhere else.

So last week, this person was subject to a third party audit. She did a great job answering the questions and was able to explain what she was looking for, show examples of good/bad parts, etc. Then she was asked about where to find the work instructions and of course could not because as far a she knew there where none as they where not given to her for this task (nor where they needed). The supervisor when asked indicated that a part print could be used if needed, but wasn't needed.

So we ended up with a non-conformance under 7.5.3 -- due to work instructions not available to operators.

Legit? Seems to me the auditor is projecting the need for documented work instructions where they are not needed. What say you? Thanks in advance.

Another auditor who needs to be shown the door for inventing a requirement.

Documented procedures (may include instructions) are required to the extent necessary for the process (includes tasks) to be effective.

You gave us no evidence of ineffectiveness.

 

[Golfman25]

It seems like the nonconformity is written to the wrong clause. Perhaps, there is a reason that documented information is not applicable, but this reason would need to be documented. It would seem to be a nonconformity to 8.5.1:

The organization shall implement production and service provision under controlled conditions.
Controlled conditions shall include, as applicable:
a) the availability of documented information that defines:
1) the characteristics of the products to be produced, the services to be provided, or the activities
to be performed;
2) the results to be achieved;

I suppose, depending on how you define the term "as applicable" and the fact that there is a workorder/traveler.

 

[Golfman25]

Another auditor who needs to be shown the door for inventing a requirement.

Documented procedures (may include instructions) are required to the extent necessary for the process (includes tasks) to be effective.

You gave us no evidence of ineffectiveness.

Cause there is no such evidence. As I said, she did a great job explaining the task to the auditor and in fact, doing her job for several years.

 

[Golfman25]

This is a great, huge load of HORSE&HIT!

1st- Did a WI actually exist? YES or NO

2nd - Was there any probelm related to the unavailablity of the WI if it in fact did exist? YES or NO

3rd - Was all the work being done as required, when required and how required in the absence of the aformentioned nonavailable WI? YES or NO?

Here's the clincher about the "missing" WI .... 7.5.1 General...The organization’s quality management system shall include:...b) documented information determined by the organization as being necessary for the effectiveness of the quality management system.....NOTE The extent of documented information for a quality management system can differ from one organization to another due to:...— the competence of persons. (Just as stated by mattador78 above)

In the end, even if you do have a WI, 7.5.1 overrides 7.5.3 1st because you might have decided that a documented WI was not necessary & 2nd the person didn't need to do it because they had been "deemed competent".....Wanna have fun? Ask the auditor where his procedures and work instructions are for him to follow, that'll shut his yap............And yes to whatever Nay Sayer wants to bite that one, mine are on my laptop as well as ANAB Rules as well as some ISO Work Group stuff.

The only real times, other that when specifically required by the applicable standard, regulation or whatever, an auditor can drop a hammer on lack of documentation, is when lack of effectiveness or lack of control can be assigned, and even then it's dicey.

Appeal that knuckleheaded nonconformance if you choose.

Yes to an actual work instruction in the form of a workorder/traveler with print. Print could be used to compare good/bad, but not really needed. Could have had pictures, but overkill.

No as to the unavailability of the WI. I would even suggest is was "available" but deemed unneeded by the supervisor.

Yes, work was being done in accordance to what was required and explained as such, even showing examples of good vs bad parts.

Appeal is in the cards on this one. Thanks.

 

[Mike S.]

I agree with the others above...it's a BS NC.

 

[Cari Spears]

It seems like the nonconformity is written to the wrong clause. Perhaps, there is a reason that documented information is not applicable, but this reason would need to be documented. It would seem to be a nonconformity to 8.5.1:

The organization shall implement production and service provision under controlled conditions.
Controlled conditions shall include, as applicable:
a) the availability of documented information that defines:
1) the characteristics of the products to be produced, the services to be provided, or the activities
to be performed;
2) the results to be achieved;

You don't need to document the reason that a documented work instruction isn't needed. This operator was verbally lined up and clearly understood her instructions as they were communicated to her. There was no nonconformity to be written to any clause.