ISO 9001:2015 Clause 8.5.1 Control of Production and service provision - Help with Work Instruction Access

[jam325]

I am having a problem with repeated findings during internal audits to the access of our work instructions and would like some advice.

I have always interpreted clause 8.5.1 a) as employees need to have access to their work instructions to reference in case of questions about their process. We are having repeated findings to this clause during internal audits due to various reasons ranging from employees having not accessed the WI in so long they have forgotten how to IT taking away employee access after system updates. The WI are generally in our document control system and up to date. The employee simply does not know how to access them.

Additionally, this inability to access WI is not seeming to cause any Quality or Production issues. Operations are carrying on normally and are hitting their defined KPIs as needed.

This has made me rethink me interpretation of clause 8.5.1. If there has been this repeated finding, but there is no impact on overall quality, should this continue to be written up as a finding or should we find a way to fulfil 8.5.1 without employees having ready access to their WI?

Thanks in advance!

 

[Sidney Vianna]

Additionally, this inability to access WI is not seeming to cause any Quality or Production issues.

That being the case, one should ask: are the WI's really necessary? Do they collect any organizational knowledge? Maybe not needed for experienced workers. What about new employees? could those documents be converted into training aids?

Any document that is not accessed by the target users and, still, there are no negative consequences in terms of product integrity, personnel safety, environmental impact, etc...is a serious candidate for obsolescence.

 

[malasuerte]

I am having a problem with repeated findings during internal audits to the access of our work instructions and would like some advice.

I have always interpreted clause 8.5.1 a) as employees need to have access to their work instructions to reference in case of questions about their process. We are having repeated findings to this clause during internal audits due to various reasons ranging from employees having not accessed the WI in so long they have forgotten how to IT taking away employee access after system updates. The WI are generally in our document control system and up to date. The employee simply does not know how to access them.

Additionally, this inability to access WI is not seeming to cause any Quality or Production issues. Operations are carrying on normally and are hitting their defined KPIs as needed.

This has made me rethink me interpretation of clause 8.5.1. If there has been this repeated finding, but there is no impact on overall quality, should this continue to be written up as a finding or should we find a way to fulfil 8.5.1 without employees having ready access to their WI?

Thanks in advance!

You can't create your own interpretation - well at least you shouldn't. This is a 'shall' statement and would need to be met. However, the clause does also state "as applicable".

So as Sidney states, these WI may not be necessary at all, or if they never change, then not needed for experienced but needed for new employees. So new employees need to maintain the access.

But, as stated, it is a valid non-conformance. So you can present it to leadership as such and work to solve the problem. Maybe IT needs to improve; maybe you need to move WI to a simpler system with a simpler point of access. Or, possibly, If the WI never changes (which it kind of sound like) could you print them out, laminate them and post them at the workstations?

 

[Big Jim]

You can't create your own interpretation - well at least you shouldn't. This is a 'shall' statement and would need to be met. However, the clause does also state "as applicable".

So as Sidney states, these WI may not be necessary at all, or if they never change, then not needed for experienced but needed for new employees. So new employees need to maintain the access.

But, as stated, it is a valid non-conformance. So you can present it to leadership as such and work to solve the problem. Maybe IT needs to improve; maybe you need to move WI to a simpler system with a simpler point of access. Or, possibly, If the WI never changes (which it kind of sound like) could you print them out, laminate them and post them at the workstations?

As you said, you can't create your own interpretation, but you did.

Work instructions are not mentioned in ISO 9001:2015. Not in 8.5.1 or anywhere else.

Work instructions were part of ISO 9001:2008/2000 in 7.5.1 b, but that standard is obsolete!

ISO 9001:2008 7.5.1 b "the availability of work instructions, as necessary"

I repeat, work instructions are not included in ISO 9001:2015. The nonconformances written for that are bogus! Or at least unless the organizations own documents require them.

 

[John Broomfield]

Time to retrain your internal auditors so they fully understand the requirements instead of wasting everyone’s time on gotcha questions.

Review audit checklists after the retraining to ensure they:

A. Are fresh for each audit
B. Are driven by the audit objective
C. State what evidence is sought
D. State why this evidence is sought
E. Leave plenty of room for recording the evidence found

Right now they are damaging the reputation of audit and the management system.

 

[jam325]

That being the case, one should ask: are the WI's really necessary? Do they collect any organizational knowledge? Maybe not needed for experienced workers. What about new employees? could those documents be converted into training aids?

Any document that is not accessed by the target users and, still, there are no negative consequences in terms of product integrity, personnel safety, environmental impact, etc...is a serious candidate for obsolescence.

This is the direction I think I am going. If we are seeing no negative consequences with employees unable to access WI, then we don't need them. We have a wide range and large number of employees in this area. Some very new, some very seasoned. Training plans for those new employees are a whole different problem.

The work instruction for this particular area is a line audit check sheet (think QC) and a shipping WI. Both are fairly straight forward and steps are controlled by the IT system.

 

[jam325]

Time to retrain your internal auditors .

Nice of you to assume we have plural internal auditors LOL.

I do agree it is time to take a hard look at the audit sheets.

 

[John Broomfield]

Do your “Audit Sheets” fulfill A thru E?

How about repurposing the unused work instructions as training materials?

 

[jam325]

Do your “Audit Sheets” fulfill A thru E?

The audit sheets do fulfill A through E, but could be improved by being updated more frequently. Currently, they are a standard set of points to check that then can lead to a deeper dive if an issue is found.

How about repurposing the unused work instructions as training materials?

The WI are the training materials. By that I mean, when we record training it is to a particular work instruction or process. When training classes are done the trainer will make a ppt or such to help with the presentation, but the training is still done to a particular WI and recorded as the employee being competent to that WI or process.

 

[Sidney Vianna]

and steps are controlled by the IT system.

Automation of processes is one of the best mistake-proofing methods and, it seems that such WI's are unnecessary. With that in mind, the finding from the internal audit could be the conclusion that such documents (muda) should be discontinued, what in itself is a leaning, improvement initiative.

Good luck.