Establish a Documented Procedure (4.2.3) vs. Establish Process (7.6)

[DAWELAH]

Dear Friends,
What does the following mean
1- Establish a documented procedure ( as 4.2.3)
2- Establish Process ( 7.6)
Really I’m confused between Procedure and Process

If I Prepare for an example “a documented procedure for Control of Documents “
And then divide this procedure to
- Purpose of Procedure
- Scope of Procedure
- Definition
- General ( gives some information related to procedure implementation )
- Related Procedure
- And then attached a flow chart, with given name “ Control of Document Process “
This process explain the step by step action needs to control mentioned Procedure ( Control of Document ) the Responsibilities and required documents are identified in the flowchart


What is your opinion? Is it work?

Please need your kind advice ?

 

[Pancho]

What does the following mean
1- Establish a documented procedure ( as 4.2.3)
2- Establish Process ( 7.6)
Really I’m confused between Procedure and Process

It may be useful to refer to ISO 9000-2005, which defines these terms:

• §3.4.1 process: set of interrelated or interacting activities which transforms inputs into outputs
• §3.4.5 procedure: specified way to carry out an activity or a process

Back in ISO 9001-2008, §4.2.3 requires you to document the way in which you control your documents, and §7.6 requires you to have processes to control your monitoring and measuring equipment. In the first case, a single procedure may be sufficient to meet the requirement, and the standard demands it be documented. In the second case, the requirement may be met by having one or more of your processes incorporate the proper monitoring and measuring activities, and the standard demands only records documentation of the calibration and verification of your equipment.

If I Prepare for an example “a documented procedure for Control of Documents “
And then divide this procedure to
- Purpose of Procedure
- Scope of Procedure
- Definition
- General ( gives some information related to procedure implementation )
- Related Procedure
- And then attached a flow chart, with given name “ Control of Document Process “
This process explain the step by step action needs to control mentioned Procedure ( Control of Document ) the Responsibilities and required documents are identified in the flowchart

What is your opinion? Is it work?

The format of the documented procedure is not as important as the content. From the definition cited above, the way in which you do document control is the substance of the procedure. Scope, Purpose, Definition, General, Related procedures, may be nice supplemental info, but the "step by step action" is what really matters. Feel free to post the substance of your procedure for some constructive criticism.

 

[somashekar]

Dear Friends,
What does the following mean
1- Establish a documented procedure ( as 4.2.3)
2- Establish Process ( 7.6)
Really I’m confused between Procedure and Process

If I Prepare for an example “a documented procedure for Control of Documents “
And then divide this procedure to
- Purpose of Procedure
- Scope of Procedure
- Definition
- General ( gives some information related to procedure implementation )
- Related Procedure
- And then attached a flow chart, with given name “ Control of Document Process “
This process explain the step by step action needs to control mentioned Procedure ( Control of Document ) the Responsibilities and required documents are identified in the flowchart


What is your opinion? Is it work?

Please need your kind advice ?

process: set of interrelated or interacting activities which transforms inputs into outputs

How transforms ?
By a procedure for each activity.

procedure: specified way to carry out an activity or a process

Is the procedure documented and controlled ?
Yes
Doumented procedure

 

[DAWELAH]

Thanks Pancho
Thanks Somashekar

I attached a draft
As you see, it is named “ Internal Quality Audit Procedure “ and the Internal Quality Audit Process ( Flowchart) is an appendixes of the procedure which is explain step by step activities with responsibilities and evidences documents .

is there any comments about the titles?

Is it fine ?

is it acceptable documentation?

 

[somashekar]

Thanks Pancho
Thanks Somashekar

I attached a draft
As you see, it is named “ Internal Quality Audit Procedure “ and the Internal Quality Audit Process ( Flowchart) is an appendixes of the procedure which is explain step by step activities with responsibilities and evidences documents .

is there any comments about the titles?

Is it fine ?

is it acceptable documentation?

Just call it 'Internal Audit Procedure'
Opening / closing meeting, if required ? Who decides it ?
Why not drop them ?
NC classification, Why ? Who decides them ? What are the guidelines for it ?
Why not drop them ?

 

[Pancho]

Thanks Pancho
Thanks Somashekar

I attached a draft
As you see, it is named “ Internal Quality Audit Procedure “ and the Internal Quality Audit Process ( Flowchart) is an appendixes of the procedure which is explain step by step activities with responsibilities and evidences documents .

is there any comments about the titles?

Is it fine ?

is it acceptable documentation?

Looks good. I'd suggest that instead of giving instructions here about NC handling and CAs, you make reference to the corresponding dedicated procedures that you probably already have. Also, on format, I think that the substance of your procedure, the step by step instructions, shouldn't be relegated to an appendix.

 

[DAWELAH]

Thank you soooooooooooooooo much friends

Your comments are very useful ?

One more query :

the step by step activities ( the appendix ) has been identified as ( Internal Audit Process )

and the chapter name is ( Internal Audit Procedure )

Is there a problem with this ?

 

[somashekar]

Is there a problem with this ?

There is no problem at all as long as it makes simple meaning to you all who manage the QMS.

 

[vanputten]

I can't remember where I got this document or how to find the it now. I think this document is available somewhere on the ISrg website or the Technical Committee (TC) 176 website (http://www.tc176.org/).

The following text is from TC176's Guidance on Documentation document:

c) Documented procedures:
 ISO 9001:2008 specifically requires the organization to have “documented procedures” for the following six activities:
 4.2.3 Control of documents
 4.2.4 Control of records
 8.2.2 Internal audit
 8.3 Control of nonconforming product
 8.5.2 Corrective action
 8.5.3 Preventive action
 These documented procedures have to be controlled in accordance with the requirements of clause 4.2.3
 Some organizations may find it convenient to combine the procedure for several activities into a single documented procedure (for example, corrective action and preventive action). Others may choose to document a given activity by using more than one documented procedure (for example, internal audits). Both are acceptable.
 Some organizations (particularly larger organizations, or those with more complex processes) may require additional documented procedures (particularly those relating to product realization processes) to implement an effective QMS.
 Other organizations may require additional procedures, but the size and/or culture of the organization could enable these to be effectively implemented without necessarily being documented. However, in order to demonstrate compliance with ISO 9001:2008, the organization has to be able to provide objective evidence (not necessarily documented) that its QMS has been effectively implemented.

 

[vanputten]

Well, I just learned that one cannot post the same attachment twice throughout all of the Elsmar Cove which seems odd to me.

Anyway, if you want to see ISO/TC176's Guidance on Documentation, go the the thread called "What defines a Quality Record?"