Do I have too many ISO 9001 procedures?

I

Ingeniero1

#11
We are starting from scratch here, but I have written similar documents (though not for ISO 9001:2000 or similar) at other companies for the sake of having documented procedures to insure continuity and quality.

My main concern was, or is, how vague can we be, or are allowed to be?

You see, I read a procedure for "Production" for another organization a couple of days ago, and it really didn't say anything more specific than "the necessary steps will be executed", "the operators are trained", "inspection is carried out", "specifications are reviewed", etc. This single procedure covered a number of processes, there were no other documents to substantiate any of the statements, and yes, they were certified about a year ago. I was flabbergasted!

I tend to be more vague when it comes to the actual work instructions. Even though we have detailed, excellent multi-media instructions for many of the tasks performed throughout the plant, we do not have them all yet. Within the procedures, I simply reference the related work instructions that are available "to be used when necessary." Since the operators are trained anyway, they normally do not need the instructions at all.

Thaks for your comments - they put mind a bit more at ease.

Alex
 
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G

Greg B

#12
ISO GUY said:
Procedures, work instructions are pretty much the same thing. They both still need to be controlled.

JMHO but this is what I tell people in our company-you need a procedure/work instruction if the absence of one would be detrimental to the product/service we are providing.
ISO,
Although Procedures and Work Instructions have to be controlled I don't agree that they are 'pretty much the same thing'
Procedures define: Who, What, Where etc , and
Work Instructions define: HOW

Alex,
I think you have to also decide what you want your documentation for. If it is to only please an auditor then mention it in your Quality Manual to show that you have responded to a clause. If it is to explain a Process then either design a Procedure or Work instruction to show the process view or steps.
We have the BIG 'SIX' condensed to four (I combine CA & PA and Docs and Records). My other procedures will be area specifc and relate directly to our process. They won't relate directly to the standard but to our work practises and include Org Charts, responibilities and authorities, Process Flow maps, cross references to WI and forms etc, A Quality Risk Matrix,

We will have the following procedures:

Mining
Calcination
Deadburning
Electrofusion
Transport & Logictics
Supply
CAPA
Doc Management
Auditing
NC Product
Management (include MR etc)



Greg B
 
W

wrodnigg

#13
Mike Smith said:
WRODNIGG
Just for clarification, Is there not seven required procedures, in theory?
6.2.2.2 "The organization shall establish and maintain documented procedures for identifying training needs and achieving competence of all personnel performing activities affecting quality".
Which standard do you quote? In my copy of EN ISO 9001:2000 there is no explicit demand for a documented procedure in 6.2.2 (and no point 6.2.2.2).

Isn't your quote 6.2.2.2 from ISO/TS 16949?
 

Howard Atkins

Forum Administrator
Staff member
Admin
#14
wrodnigg said:
Which standard do you quote? In my copy of EN ISO 9001:2000 there is no explicit demand for a documented procedure in 6.2.2 (and no point 6.2.2.2).

Isn't your quote 6.2.2.2 from ISO/TS 16949?

Yes you are right.
This is an additional TS requirement
 
A

Aaron Lupo

#15
Greg B said:
ISO,
Although Procedures and Work Instructions have to be controlled I don't agree that they are 'pretty much the same thing'
Procedures define: Who, What, Where etc , and
Work Instructions define: HOW
Greg that is why I said JMHO (just my humble opinion). We have WI's that not only say how but who, what where and when. It all depends on what type of product/service you are providing. Remember WI's and Procedure definitions are not one size fits all. Again JMHO. :bigwave:
 
D

David Hartman

#16
ISO GUY said:
Remember WI's and Procedure definitions are not one size fits all. Again JMHO. :bigwave:
Greg B,

Additionally, there is NO real requirement for the three/four tier documentation system. I have worked with small businesses that had approximately twenty 1-2 page documents that addressed Who, What, When, Where and How (and this was to comply with ISO 9002:1994 and QS-9000).

Ingeniero1,

The only recommendation that I can offer, beyond the sage advice that you have already received, would be to examine the possibility of documenting the competency of the employees (through training records, demonstrated expertise/experience, formal education, etc.) then move towards eliminating as many "instructive" documents as you can. Provide them with process flows that define the process, but allows them to use their training and experience to determine the "hows".
:)
 
I

Ingeniero1

#17
Greg,
I also agree with the difference between Procedures and Work Instructions; and that's how I have written them. (Actually, they have been, or are being written in a collaborated effort – several people involved with each one.)

You hit the nail on the head when you mentioned the purpose of the Procedures. Of course, the Procedures have to be acceptable to the auditor, but I also want them to be of real practical value to our operation, and we do need them.

I guess the (my) ultimate question would be:
If I have the Procedures required to fully satisfy the Standard, let’s arbitrarily say 10 in number, does it serve any purpose to include additional Procedures (not Work Instructions) as part of the set of Procedures that will be audited as such? Or should the additional procedures just be left alone as internal documents that are not subject to the audit?

Alex
 
A

Aaron Lupo

#18
See this is where people get hung up, they say "ISO only requires 6 procedures" and yes you would be correct there are only 6 places in ISO 9001:2000 that specfically call out you must have a procedurtes for.... However, ISO also states you need to comply with all the Statatury and Regulatory requirements for your industry, noe evealute that and see how many procedures you need. The amount of procedures you need is not a one size fits all the more complex your business I would venture to say the more procedures you will need. JMHO
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#19
Ingeniero1 said:
I guess the (my) ultimate question would be:
If I have the Procedures required to fully satisfy the Standard, let’s arbitrarily say 10 in number, does it serve any purpose to include additional Procedures (not Work Instructions) as part of the set of Procedures that will be audited as such? Or should the additional procedures just be left alone as internal documents that are not subject to the audit?

Alex
In my opinion, you are asking the wrong question. The question you have to ask is:

How do YOU control processes that are critical, in the absence of DOCUMENTED procedures?

Like many people alreay explained, Procedures serve the purpose of defining a PROCESS. If the process is trivial/non-critical, chances are you don't need a procedure. If you want an important process to be executed consistently, you should document it SOMEHOW. It is all part of knowledge management and going away from the "tribal knowledge" way of running an organization.

For example, ISO 9001:2000 does not mandate a documented procedure for the Design and Development processes. In my estimation, however, unless you are designing a VERY simple, non-critical item, you MUST have (a) documented procedure(s), defining your design processes.
 
O

obaraguy

#20
Thanks Mike! :applause:

You took the words right out of my keyboard. I was looking for 6.2.2.2 and procedure demand, but couldn't find it anywhere.

Obaraguy
 
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