Number of Documented / Controlled Procedures Required by TS 16949

Hi all,

...I am looking at completely re-writing the current procedures manual in a company I have just joined. there are currently "numerous" (& complex & too many procedures).

I remember an auditing course I did a while ago, where we were given an indication of the number of "general / overview" procedures that where needed to comply with TS. (ie not incuding specific product instructions), in a fairly straightforward, "inline" process (ie melt - mould - drill - pack) type process what number of procedures would you expect to see?

..many thanks for any input

Re: No of documentred / controlled procedures required

It should never be a question of how many documents someone at a distance--including a CB auditor--expects to see. If you have a feeling that there are too many, there probably are. Nonetheless, you shouldn't go about this by count. Beyond the documents specifically required by the standard, you should have as many as necessary to convey the information and requirements that need to be conveyed.

Re: No of documentred / controlled procedures required

Stubod said:

Hi all,

...I am looking at completely re-writing the current procedures manual in a company I have just joined. there are currently "numerous" (& complex & too many procedures).

I remember an auditing course I did a while ago, where we were given an indication of the number of "general / overview" procedures that where needed to comply with TS. (i.e. not including specific product instructions), in a fairly straightforward, "inline" process (ie melt - mould - drill - pack) type process what number of procedures would you expect to see?

..many thanks for any input

Click to expand...

ISO/TS 16949:2009 requires 7 mandatory procedures.
Manufacturing processes must be supported by work instructions.
Control (quality) plans are required.

The content and detail of procedures and work instructions depends on process risk and the competencies of the user community.

Always keep this simple question in mind:
What information do your people need to be:

• Safe?
• Effective? and
• Efficient?

Best!

Stijloor.

Re: No of documentred / controlled procedures required

Stubod said:

Hi all,

...I am looking at completely re-writing the current procedures manual in a company I have just joined. there are currently "numerous" (& complex & too many procedures).

I remember an auditing course I did a while ago, where we were given an indication of the number of "general / overview" procedures that where needed to comply with TS. (ie not incuding specific product instructions), in a fairly straightforward, "inline" process (ie melt - mould - drill - pack) type process what number of procedures would you expect to see?

..many thanks for any input

Click to expand...

ISO TS standard require only 7 mandatory documented procedures: 6 are the same of ISO 9001 ( document control, records control, internal audit, control of non conforming product, corrective actions, preventive actions), the tth procedure is related to training.
If the organization needs other documented procedure to manage its QMS processes, this is an organizational decision, that should derive from a risk assessment

Re: No of documentred / controlled procedures required

Stijloor said:

ISO/TS 16949:2009 requires 7 mandatory procedures.
Manufacturing processes must be supported by work instructions.
Control (quality) plans are required.

The content and detail of procedures and work instructions depends on process risk and the competencies of the user community.

Always keep this simple question in mind:
What information do your people need to be:

• Safe?
• Effective? and
• Efficient?

Best!

Stijloor.

Click to expand...

We stayed in sync in the response, also at the same time

Re: No of documentred / controlled procedures required

Jim is right on the money (as ever!)

The audit trainer may have been talking about the (in)famous 7 requirements for documented procedures. After that, any/all documentation is what's defined by the organization to ensure effective control of it's processes and activities - so the actual list is likely to be longer than just the 7...

Before you throw the baby out with the bath water, you might want to look at the actual issues you're faced with, not just the number of documents. Changes to a somewhat mature system are better done incrementally, with the input of the people (process owners) rather than 'do it all yourself', including the deletion of documents!

Re: No of documentred / controlled procedures required

..brilliant response...exactly what I was looking for...many many thanks

(NB I am not looking to "cut corners"..I will generate as many procedures as we think relevant to carry out the tasks requried...I was just after the basics....)