Using Control Plans as Work Instructions

V

vanputten

#11
I do not know where in the standard it states you have to have a quality plan. It depends on which standard you are referring to. If you are speaking of ISO 9001:2000, I believe there is no requirement for quality plans but there is a requirement for quality planning.

ISO 9000:2000 defines Quality Plans, see 3.7.5. Also, on page 25 of ISO 9000:2000 there is a diagram showing the relationship of the different types of documents including quality plans. Read page 20 first to understand how to read the diagram.

Finally, ISO 10005 was a published quideline for quality plans. Obtaining a copy of this guideline may help you also.

Regards, Dirk
 
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Al Rosen

Staff member
Super Moderator
#12
vanputten said:
I do not know where in the standard it states you have to have a quality plan. It depends on which standard you are referring to. If you are speaking of ISO 9001:2000, I believe there is no requirement for quality plans but there is a requirement for quality planning.

ISO 9000:2000 defines Quality Plans, see 3.7.5. Also, on page 25 of ISO 9000:2000 there is a diagram showing the relationship of the different types of documents including quality plans. Read page 20 first to understand how to read the diagram.

Finally, ISO 10005 was a published quideline for quality plans. Obtaining a copy of this guideline may help you also.

Regards, Dirk
Dirk, this is the automotive forum and they have additional/different requirements from 9k2k.
 
N

new_one

#13
Al Rosen said:
Dirk, this is the automotive forum and they have additional/different requirements from 9k2k.
Al, please explain what you mean versus just pointing out Dirk's apparent misunderstanding, thanks. It would be helpful.

I really wonder if the standard ISO:TS 16949:2002 is referring to the quality plan as quality planning and the whole process of product realization. Versus what some people believe to be a controlled form for each process itself.

I wish I could start a poll, because I really want to know how many of you fellow quality guru's think of the quality plan as one physical document per part/process or how many think of it as the entirety of the system.
 
Last edited by a moderator:

Al Rosen

Staff member
Super Moderator
#14
new_one said:
Al, please explain what you mean versus just pointing out Dirk's apparent misunderstanding, thanks. It would be helpful.
The only point I was making was to not mix apples with oranges. If you are referring to the requirements of TS 16949 then pehaps reference to TSO 9001 is irelevent and it wouldn't matter that ISO 9001 doesn't require a quality plan. I happen to think that a quality plan in some form is required for ISO9001:2000 (Ref: 7.1 & 7.1 note 1).
7.1 Planning of product realization
The organization shall plan and develop the processes needed for product realization. Planning of product realization shall be consistent with the requirements of the other processes of the quality management system (see 4.1).

In planning product realization, the organization shall determine the following, as appropriate:

a) quality objectives and requirements for the product;

b) the need to establish processes, documents, and provide resources specific to the product;

c) required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance;

d) records needed to provide evidence that the realization processes and resulting product meet requirements (see 4.2.4).

The output of this planning shall be in a form suitable for the organization's method of operations.

NOTE 1 A document specifying the processes of the quality management system (including the product realization processes)
and the resources to be applied to a specific product, project or contract, can be referred to as a quality plan.

NOTE 2 The organization may also apply the requirements given in 7.3 to the development of product realization processes.
I also don't believe that a quality plan is a work instruction. It would however, reference work instructions as well as processes and inspections to be performed with the equipment to be used.

So whatever you want to call it the output is a quality plan. Since I am not familiar with TS, can you enlighten me and describe a control plan or provde an example? Thanks.
 
N

new_one

#15
Al,

Thanks, I now understand where you were going. A little more detail helped. A control being the AIAG formatted control plan. I am playing the devils advocate here, just a little. I think I have gotten plenty of information from this post. However, it is confusing and I would hate for others to come along and read the post, and wonder what is the answer. It appears there is no clear answer.

I do think we have decided the quality is not 'one single document' and probably not a single document per process. Unless of course, we specify it as such. There is a difference between the quality plan and the control plan. And I don't know if the work instruction issue was really resolved. I have my suspicions as to what I am going to do, or press for and I think any auditor will give it two thumbs up. Or so I am hope I am right.
 
V

vanputten

#16
Thank you for pointing out that this is the TS 16949 forum. If you check "Wow What a Job's" original posting, the question was asked within the context of ISO 9001. The moderator moved the thread to the TS 16949 forum becasue it was beleived to be a TS 16949 question. The original question was asked in relation to ISO 9001:2000.

Quality Planning and a Quality Plan are not the same thing. Just as a process and a procedure are not the same thing. Quality planning is an action. It is not a noun; not an object. A quality plan is an object; a document (which can be in a paper format, electonic format, etc.). One output of quality planning could be a quality plan.

I pointed out that ISO 9001:2000 does not require a quality plan but does require quality planning, becasue that original question was asked within the ISO 9001:2000 context.

ISO 10005 provides more clarity on quality plans as an output of quality planning.

Regards, Dirk
 
N

new_one

#17
vanputten said:
I pointed out that ISO 9001:2000 does not require a quality plan but does require quality planning, becasue that original question was asked within the ISO 9001:2000 context.
Regards, Dirk
Dirk, thanks, you are correct in, I started this out in the context of ISO9001 and not TS necessarily.

I think I have my answers now, or at least more clarity as I move forward.
 
M

MBranco

#18
Hi, sorry for my mistake, I couldn't start a new thread, so I'm using yours... hope you can forgive me :confused:

In a previous company I knew a Control Plan that included, in the first column, the process flowchart, and then, in each line of process, the complete process controls appears, like normal Control Plan - very easy way to get all the "picture" in front of eyes:rolleyes: and then link to FMEA....

Does anyone know and/or have such a format that you can post in ??

Thanks in advance, and again, so sorry to intrude :eek:

Marta
Portugal
 
S

sixsigmais

#19
You can combine the control plan and the WI into one or seperate it to two. Both of them are fine and it is depend on you. ISO never ask you how to do, they only request what to do. As long as all the information needed are input is fine.
 
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