Clause 7.5.3 and Required Work Instructions

[Big Jim]

Interestingly enough the term "work instruction" is no longer used anywhere in the current version of the standard.

It was mentioned but only slightly in the 2000 and 2008 versions. (I'm not familiar with earlier ones than that so I don't know if they required work instructions or not but I suspect they did.)

Where it was mentioned in the 2000 / 2008 version was in production under controlled conditions (then element 7.5.1, now element 8.5.1). Back then it said "availability of work instructions, when needed"

Guess who got to determine the "when needed". The organization did, not the auditor.

So even under the older standard your auditor would have been wrong.

Don't just contest the nonconformance, also ask that auditor never return. He can't be trusted to do his job correctly.

 

[Golfman25]

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.

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.

 

[Big Jim]

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.

If the CB has not already told you, they should have, but now that the CB has turned you down, it can be appealed to the accreditation body. I rather believe that the AB (accreditation body) won't tolerate the CB's behavior.

 

[Sidney Vianna]

If the CB has not already told you, they should have, but now that the CB has turned you down, it can be appealed to the accreditation body. I rather believe that the AB (accreditation body) won't tolerate the CB's behavior.

The escalation of a nonconformity validity appeal to ANAB is understood as a complaint about CB's performance according to ANAB's Certification Client Bill of Rights and Responsibilities.
"... If this process is not resolved to the satisfaction of the client, the appeal may be elevated to ANAB as a complaint for further consideration..."

It should be noted that ISO 17021-1 requires the CB to have both AND SEPARATE appeals and complaints handling processes. A denied appeal could be followed up with a formal complaint to the CB, before escalation to the Accreditation Body; in practice, very few people issue formal complaints to their CB's for fear of aggravating the relationship.

 

[Tagin]

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.

• 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 how this 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").

 

[Randy]

How is it determined which tasks require a work instruction to be necessary or not?

Really? How is it determined? Well flitter "We sit around in a circle spitting into 2 bottles, 1 for a WI and 1 for no WI and whichever one fills up 1st is how we determine Horse&hit like this...........PROVE US WRONG!

 

[qualitymanagerTT]

Really? How is it determined? Well flitter "We sit around in a circle spitting into 2 bottles, 1 for a WI and 1 for no WI and whichever one fills up 1st is how we determine Horse&hit like this...........PROVE US WRONG!

But nobody aims for the bottle for the WI...

 

[qualitymanagerTT]

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.

From the ISO OBP:

work instruction
detailed description of how to perform tasks
EXAMPLE:
Detailed written descriptions, flow charts, templates, models, technical notes incorporated into drawings, specifications, equipment instruction manuals, pictures, audios and videos, checklists or combinations thereof.
Note 1 to entry: Work instructions can be documented.
Note 2 to entry: Work instructions describe any materials, equipment and documented information to be used. When relevant, work instructions include acceptance criteria.
ISO 10013:2021, 3.1

As per note 1, tell the auditor the CA is that you decided to have WI, but not to document it

 

[Golfman25]

From the ISO OBP:


As per note 1, tell the auditor the CA is that you decided to have WI, but not to document it

That's actually kind of the point. Obviously, we had to instruct the employee on what to do and how to do it. She was doing it in a competent manner. It just wasn't a task worth the time and effort of documenting a formal WI. Now they are saying we need to go one step further and document the fact that we didn't document the WI in the first place. I find it hard to believe people at a CB can be this stupid and just keep making up requirements. It has to be intentional.

 

[Sidney Vianna]

I find it hard to believe people at a CB can be this stupid and just keep making up requirements. It has to be intentional.

When you deal with a commoditized service such as management system certification, you tend to have low paid people employed. Low paid people tend to be on the lower range of the intelectual ability spectrum, so dumb decisions are not surprising. The expectation that an organization would have to document the rationale NOT to develop a work instruction is as asinine as they come. It is so dumb that it deserves it's own Dilbert strip.

The following is the guidance from ISO/TS 9002:2016: