Is this procedure ISO 9001 Clause 4.2.3 Compliant?

[Jim Wynne]

I am afraid that in an audit, you have to care. All laws/egulations/guidances are written with careful use of these two words. A deviation from "shall" will cost you an NC. A deviation from "should" may not if you know how to handle the situation. The former is a requirement; the latter, a suggestion/recommendation.

I'll bet that in no more than a few minutes I can find "laws, regulations and guidances" that don't hold to your rule. What Stijloor said was correct; it's not necessary to write internal documentation in the legalistic style of the standard. Whether the passive or active voice is used is a matter of stylistic preference; I'm with Stijloor in preferring the active voice. "Shall" suggests something will happen in the future. Saying "Parts are verified prior to shipment" doesn't remove the imperative.

 

[treesei]

it's not necessary to write internal documentation in the legalistic style of the standard. .

I agree it is not required. However, in a regulated industry, it would be a smart practice to be close to the regulatory language which the inspectors are used to.

Whether the passive or active voice is used is a matter of stylistic preference; I'm with Stijloor in preferring the active voice. .

Agree. I have no problem with this and am a supporter of using active voice wherever possible.

"Shall" suggests something will happen in the future. .

Here are the definitions from Websters.
http://www.websters-online-dictiona...lq&cof=FORID:9&ie=UTF-8&q=shall&sa=Search#922

http://www.websters-online-dictiona...q&cof=FORID:9&ie=UTF-8&q=should&sa=Search#922

Saying "Parts are verified prior to shipment" doesn't remove the imperative.

Agree. All I was talking about was the use of "shall" and "should".

 

[Jim Wynne]

I agree it is not required. However, in a regulated industry, it would be a smart practice to be close to the regulatory language which the inspectors are used to.

You haven't told us why you think it's smart practice. Should you?

 

[treesei]

We are getting

Let's just talk about the FDA. In 21 CFR 801.1, the first section of the general labeling provisions for medical devices, there are 9 sentences. The word "shall" is used 7 times; the word "may" is used 4 times. This example may tell us how frequently "shall" is used in regulations and how an FDA officer is used to such language and definitions. I suppose I can use "must" to replace "shall", but why not use a language and definitions (in which "shall" is only a tiny example) in my inspectable documents that align with the regulations and the inspectors are familiar with?

Back to topic: While "must" may be used to replace "shall", "should" cannot. "The label of a device in package form shall specify conspicuously the name and place of business of the manufacturer, packer, or distributor" (21 CFR 801.1(a)) is different from "The label of a device in package form should..." I brought the issue up because Kirin's procedure contains several "should" and I wonder whether the procedure was making requirements or suggestions. "Parts are/shall be verified prior to shipment" is different from "parts should be verified prior to shipment" even in an internal document. If my internal auditor blamed me for not having all parts verified prior to shipment and my procedure said I should, I would argue with all reasons and excuses and I might win.

 

[AndyN]

We have drifted of topic and off standard - this is the ISO 9001 forum, so it may not be as helpful to discuss what regulated industries 'require', for these particular examples.

However, there is a principle at stake for any QMS:

If my internal auditor blamed me for not having all parts verified prior to shipment and my procedure said I should, I would argue with all reasons and excuses and I might win.

Why would you argue, in this case, with an internal auditor?

 

[treesei]

This actually applies to audits in general.

Why argue? 1) To avoid an unnecessary NC from my department on his/her audit report. 2) The auditor needs to understand the difference between "shall" and "should".

How to argue:

1. First I should take the "should" with respect and normally do verify my parts prior to shipment and record it. This is my basis of compliance.

2. Fundamentally, by definition, "should" does not obligate me to verify every part prior to shipment. In other words, based on risk analysis and business necessity, I can make deviations. This is my basis of argument.

3. Say, in a particular situation, if I verified my parts as usual I would miss an important shipping date leading to some significant consequences, and I held high confidence of my parts that they would pass, (and possibly with customer agreement,) the "should" procedure would allow me the possibility of deviation w/o non-compliance.

4. Of course, such deviation must be exceptional and decision making rationale must be recorded.

5. Under extreme situations I believe people would break the "shall" promise as well but "should" certainly gives more flexibility. If the process owner does not like such flexibility, use "shall".

 

[JaneB]

Enough with the "shall vs should".

There are some uses of language I won't give up on without debate, but this is definitely not one of them. Because whoever uses 'shall' in everyday normal language? (except people who write Standards and people who write procedures/manuals based on their wording).

It just isn't used very much these days, and I really see very little point in the use of a term that's now relatively out of date. I'm willing to be that the 'average' person would have a lot of difficulty in knowing, let alone explaining the difference between shall and should.

Why not use something that IS everyday, normal language, such as 'must' to make something mandatory?

 

[Kirin]

Thank you all very much for your responses; i shall take your points into consideration. I will remove the numbering and might add a small introductory sentence just to give some context.