Clause 7.5.3 and Required Work Instructions

[Big Jim]

• There is no requirement in 7.5 to document what was determined not to be necessary.
• There is no requirement in 7.5 to document howthis determination was reached.
  • E.g., if you had done a PFMEA, you might have had a mention of work instruction with a low risk RPN, and that shows you had thought about it. However, there is no requirement for a PFMEA or such.
• There is no mention or implied requirement of documentation in the definition of 'determined' in 9000:2015 3.11 ("Terms related to determination").

I'm guessing that this response was from the auditor, not the certification body. I have seen some idiotic things certifications bodies have done, but never one this bad. I really don't see how an accreditation body would back this up, but who knows.

 

[Cari Spears]

So my appeal was REJECTED. Here is the exact wording given to me:

"Although the client is correct in the verbiage of the clause, the word “determined” is key in this clause. How is it determined which tasks require a work instruction to be necessary or not? Where in the client's procedures was it determined and documented that this particular task does not need a set of work instructions?"

So it seems you hit the nail on the head and are at odds with my CB. Is this not a circular argument -- you need to document the fact that you don't need a documented work instruction? What the hell.

Preposterous!

 

[mattador78]

So my appeal was REJECTED. Here is the exact wording given to me:

"Although the client is correct in the verbiage of the clause, the word “determined” is key in this clause. How is it determined which tasks require a work instruction to be necessary or not? Where in the client's procedures was it determined and documented that this particular task does not need a set of work instructions?"

So it seems you hit the nail on the head and are at odds with my CB. Is this not a circular argument -- you need to document the fact that you don't need a documented work instruction? What the hell.

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.

Well the answers there isnt it? If its not in it was determined it wasnt needed, it doesnt ask you to show how that was determined just that if it is determined then document it. Does your process instruction or contract review cover this? Our datacard states that items are to be sorted and inspected no specific instruction.

 

[Randy]

determined

My definition of the "determination" process stands, though my original "chicken bone" theory for environmental significant aspects could work just as well.

 

[Sidney Vianna]

 

[Gauge Girl]

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.

I personally think there should be work instructions especially for specific parts because the person is searching for specific details. Whether it be a date that should be in a certain place or for a defect that may occur only on that part. IMHO I think there should be instructions for operators to read and follow so they know what to look for. Even add photos for what the defect would look like.

 

[Golfman25]

I personally think there should be work instructions especially for specific parts because the person is searching for specific details. Whether it be a date that should be in a certain place or for a defect that may occur only on that part. IMHO I think there should be instructions for operators to read and follow so they know what to look for. Even add photos for what the defect would look like.

So that need for a documented work instruction isn't tempered by anything, such as the simplicity of the task? Verbal instructions are not acceptable in any case? How do you feed such a beast when running over 2500 different part numbers?

 

[Randy]

I personally think there should be work instructions especially for specific parts because the person is searching for specific details. Whether it be a date that should be in a certain place or for a defect that may occur only on that part. IMHO I think there should be instructions for operators to read and follow so they know what to look for. Even add photos for what the defect would look like.

People can successfully carry out tasks without work documented instructions and have done so for centuries & millenia......... How many documented instructions were there for the Bushmen of the Kalahari to find water? How about documented instructions for the success of armor makers in the Middle Ages? How about documented instructions for the Vikings to make it across the Atlantic? What about documented instructions for the Babylonia to make mud bricks for their cities?

Don't get all wrapped around the axel.

"I personally think" ....and that's where the problems start, the auditor "thinks" but doesn't really "know".

 

[Mike S.]

I find it hard to imagine someone was dumb enough to write this up. I know that I am too naive. The harm this kind of stupidity causes is unknown in its scope, but it does indeed do harm.

 

[Golfman25]

I find it hard to imagine someone was dumb enough to write this up. I know that I am too naive. The harm this kind of stupidity causes is unknown in its scope, but it does indeed do harm.

It does incredible harm. I come from the old days when it was call "a-hole" 9000. Had to do a lot of convincing to my people to accept and adopt it. One commitment I made was that we would only do things that "made sense" and not because an auditor said so. Unfortunately, I have had to go back on that commitment more times than I like. Nothing was worse than the dueling auditors with different opinions -- one said we had to do this, the next said doing "this" was stupid. That's why I fight as best I can these days, but it's a loosing battle. ISO no longer provides any value to our organization.