New ISO 9001... RBT seriously ... what could happen.

All my work instructions are in English.
My RBT now tells me that my workers really do not know to read and understand the instruction in English.
They are local language Tamil literate.
When discussed with the workers they preferred work instruction and that to be in local language
I decide to properly convert all work instructions into Tamil.
My CB auditing language is agreed to be English.
The auditor comes in and finds that I have applied the due RBT and the change now is work instruction language.
He is unfortunately not Tamil literate.
I may even further decide to have the same work instructions in two other local languages based on personnel ability and my RBT.
How would the CB's assess this..
What could happen ... ?

 

Somashekar,

It didn't take a revised ISO standard to make sure your employees could read the instructions, right?
This is hypothetical? Please say yes...

 

Not at all hypothetical. You need to visit this part of the world to see for yourself. Contract manufacturing industry are pushed with developing work instructions that the principle approve before use. English is the most preferred for this. This gets into the place of work as well. Ask an operator here to read the procedure in front of him and explain what he does., you will find soon how much I mean it ~~~~~

 

Let me say this, I haven't read a page from the new ISO 9001 draft, but I get a feeling that we are perhaps reading too much into RBT. Sometime back when I read an article, I was given to understand that ISO/TC claims that the idea of RBT is already inculcated in the existing Standard, albeit not explicitly and there is nothing peculiar about it . I haven't faced third-party Audit for a while, but when I get to visit our Suppliers for Audit, we always insist that Work Instructions be in a suitable language to serve its purpose. Are we saying that, in the current version of the Standard, it is okay to have a Work instruction for a guy who understands nothing in it?

 

No Ganesh. In a situation where the work instruction is in English, when the documented information is looked afresh to the ISO9001:2015 requirement, one of the RBT that surfaces is obviously this.
That you mentioned about suitable language., do all of them who are into the 2008 version and progress into 2015 version have considered suitable language requirements for work instructions ?
What are the risks in not having considered it ?
1. Is it readable and the user's activity matches the document ?
OR
2. Is it not readable and therefore a risk of the user's activity deviating from instruction exists that can further become a critical defect ?

Then the decisions output could be ...
1. Provide work instructions in the suitable language of the user.
OR
2. Do not put it at the point of use.

This does not mean that the work instruction is not made at all. If you have them made in English and they are required, most certainly they can be internal knowledge that is put to use in training purposes.
Also as an outcome of the RBT, think if work instructions can be like a visual aid / representative sample with activity title being in English only, and numbered accordingly., and the user has the ability to relate the work step to the number in the visual aid.
Does this address the Risk at 2. above ? To address the Risk 2. has the user been consulted suitably ?

 

I come from a multilingual country and have migrant workers from at least 5 countries. Most organizations adopt English as the language for documentations. All others are translations - when in doubt, refer to the English version. It is easy for the 4 main languages used in the country but difficult for the languages of the migrant workers. We therefore use a combination of words and pictures in WIs for example. If the workers are able to demonstrate that they are consistently doing things according to procedures or WIs, we can deduced that they had understood the said procedures or WIs.

With regards to CBs, we can request for auditors who knows specific languages or combinations of it. Most auditors are dual or trilingual.

 

Having local work instructions, etc., in the local language is a key requirement for communication, understanding and implementation; and is not a problem during a 3rd party audit. If necessary, the QMR or another appropriate person can verbally translate needed sections for the external auditor.

 

A picture speaks a thousand words in any language. I would agree that notification to the CB is required so arrangements could be made to accommodate the language challenge.

 

You shouldn't need a new version of ISO9000, a risk analysis, or a documented procedure to understand that your work instructions are not legible to those assigned to use them.

I don't have an older version but as far back as 2000, Section 4.2.3 Control of documents, e) reads "[A documented procedure shall be established to define the controls needed] to ensure that documents remain legible and readily identifiable."

From Merriam-Webster:
legible
1: capable of being read or deciphered
2: capable of being discovered or understood

I would expect that deciding to employ a factory full of people that do not read English, when all of your work instructions are in English, would come up in Management Review under the heading of Section 5.6.2 Management Review input f) "changes that could affect the quality management system" (again, 2000 version).

 

I would think it would first be noted when the order was made wrong four times in a row,
someone cut off their thumb,
or when the floor supervisor saw a bunch of people scratching their heads talking to each other and pointing...

Finding it in the standard would be the third "doh" in the process...the first one being the floor super, and the second being the plant manager he told...

 

Work instructions explain how the work must be done to those doing it. If a document is unreadable to the folks actually doing the work, then, whatever the document is, an instruction it is not.

Further, having qms documents in a language other than that of the workers handicaps your workers from contributing to continuous improvement.

Clients, auditors and others that may want to know how you control quality should understand this. They can get translations of work instructions if they wish and if you are willing to provide them. Such translations could be excluded from the qms, as these may be uncontrolled without affecting your quality. They can be updated much less frequently than the living docs in the system.

In our experience, auditors provide personnel that can read the local language, and clients settle for records in their language. We keep forms in dual languages for that purpose.