Looking for Input on our Quality manual from TS 16949 Guru's

[TamTom]

Re: Looking for Input from TS Guru's

We're all set now, though?

Nice job getting it down to 8 pages, like the diagram in the back! I just have an aversion to using the words/format of the standard, that's all Tom!

Hello Tom,

I totally agree with AndyN, using the format of the standard fulfilles it, but it normally doesn't fit your company. As hard as it is, these 8 pages will nobody read in your company.

If you rework it, then make it fit your company.

Take a look in the forum and you will find some good examples for process maps etc.

Regards,

TamTom

 

[Tom W]

Thanks to everyone that has taken the time to review and respond.

I think some clarification might be in order here.

I am looking to reduce the size of the quality manual; that’s it...nothing more.

I do appreciate all of the comments and I am definitely going to consider all of the comments and suggestions.

For comparison purposes I have attached a copy of two of the 21 policies that currently reside in our policy Manual. Please keep in mind that we have the traditional Level 1 Policy Manual; Level 2 Procedure Manual; and Level 3 Work Instructions all originally created back in 1999 under QS. The meat is in the procedures and work instructions. Our policies were set up to start the conversation about the topic then the procedures repeated most of that and added more substance to it.

Over the last 4 years or so when we have been audited none of the auditors even opened the quality manual; they jumped to the procedures where the detail is. This might be because of the maturity of the system or the familiarity of the auditors with our system.

My desire is to truncate the manual to reduce the documentation nightmare while streamlining our procedures to be more direct and informative rather than to cumbersome and wordy.

Thanks again and I look forward to more discussions - this is the best litmus test there is.

 

[zancky]

Over the last 4 years or so when we have been audited none of the auditors even opened the quality manual; they jumped to the procedures where the detail is. This might be because of the maturity of the system or the familiarity of the auditors with our system.

Hi Tom,
thanks a lot for sharing,
I have just given a look to your manual and I wondering why you didn't cite CQI-9 which, I suppose, is fundamental for You.

thanks

 

[Tom W]

OK Tom, the honeymoon's over...While I too, admire your continual improvement efforts with regard to the Manual, the following are some observations which I believe merit your attention:

1) Quality System Policy Manual???? I think you need to change the name... What you've provided is not a "Policy Manual"....maybe a "System Manual" or "Business System Manual", or "Management System Manual". Also, you might want to avoid calling it a Quality Manual, which to many, implies that it relates only to the "Quality Department", and or only to "Product Realization" processes.​

It is called the Quality Systems Policy Manual - in reference to the quality system; which in most cases is understood to be the Quality Manual representing the overall policies of the quality system. I can see where changing the title could help unfamiliar reviewers understand what it is more easily. I will consider this carefully - but don't want to throw off the masses that are not as knowledgable of the subject matter of quality.

2) Processes in your "Quality Management System" - there seems to be a discrepancy between the processes listed in the document and the processes listed on your "Process Interaction Chart".
You don't mention "Receiving", "Processing", "Final Inspection" and "Shipping", etc., in your "narrative", and yet your diagram calls them out as "Key Processes".

As the manual is intended to address the quality management system as it relates to how we address the TS standard it is not intended to identify each operation or process within the entire organization and explain how each one interacts. As with any business model there is a key process flow and the diagram is intended to illustrate how many of the processes interact to the key process flow - not how every process interacts with every other process...the key process flow is our business model for waht we do it is covered in teh process control procedure as well as countless others.

3) Support Process - You have not demonstrated any sequence or interaction for all your support processes. Additionally, not all of the "Support Processes" which appear on your diagram are called out in the "Manual". Overall, I thing that your Process Interaction Diagram fails to demonstrate that your "System" conforms to the "Plan, Do, Check, Act", model, and does not convince me that your Management System embraces the basic ISO/TS philosophy. Your model demonstrates more about Product Realization than it does about the sequence and interaction of your management processes, as set out in 4.1.a and b.

First let me say that the diagram does not have to embrace the Plan, Do, Check, Act model as traditionally understood. But in my opinion it certain does reflect this model. We have planning in the upper right hand corner that leads to the doing at the beginning of the key flow, we have the checking in the form of inspection and we have the acting as it relates to satisfying the customer or correcting issues. The support processes flow in and out of the key processes - showing the interactions on this diagram would make this diagram useless to most people as it would look like a mess of lines and boxes rather than displaying the key process flow which we are actually required to show in some state per TS. If you will refer to the diagram again; you will see that the green boxes are identified as our key processes and the blue boxes are the support processes distributed through the key processes flow.

That's what is great about the Cove and the input - everyone has their own interpretations and ideas - That's what makes me excited about this feedback - to gain others perspectives.

4) Red Box at bottom of diagram includes: CONTROL OF NONCONFORMING PRODUCT / ROOT CAUSE ANALYSIS / CONTINUAL IMPROVEMENT...Should there be a link or interface with your "Corrective/Preventive Action Process" at this stage?

The nature of our system is that corrective and preventive actions refers to more than just product related nonconformities and activities - thus it is listed in the support processes as it supports the entire system; and the Control of Non-conforming product is listed in reference to the key production process. But I can see what you mean here.

5) Process Design and Development - is this a QP?

This is covered in the section for Product Realization and refers to several procedures that communicate these requirements.

6) Contingency Plan Procedure (QP-9.6). - This is identified in the Manual, but is not on your Process Interaction Diagram.

This falls under our business planning process and our process control process. For example - product audits are not listed under the support processes either but it is under the internal audit process and the monitoring and measuring process.

7) Control of Customer Supplied Product (QP 7.1)....Is also identified as a "System Process", but is not on your Diagram.

8) Identification and Traceability Procedure (QP-8.1).
Handling, Storage, Packaging, Preservation, and Delivery Procedure (QP-15.1), and Handling, Storage & Inventory for Process Materials (QP-15.3). - Why aren't they included in the diagram?

You are correct - I should have them listed as support processes and will revise ; however documentation wise within our system they are covered extensively as everything we process is customer supplied product - we manufacture nothing.

9) Monitoring and Measurement - While I'm pleased to read that you have a Monitoring and Measurement Procedure, again, I don't see it on your Diagram, and it is a critical link and interface between many of system processes. Also, it seems to me that 4.21 (Monit'g & Msm't) and 4.23 (Analysis of Data) are really one process. Also, why do you call out 4.23 as deserving a separate heading, and yet, no procedure is defined? Is it just because the Standard doesn't make it mandatory?

I beleive they are two distinct processes as the analysis of data refers mainly to determining the effectiveness of the quality management system and not so much the product itself as the monitoring and measuring process does. However I think you are right as this could be clearer. We have Incoming Inspection and Final inspection listed but the entire process of monitoring and measuring should be listed as well as we have the measurement of customer satisfaction listed as 'satisfied' or 'dissatisfied' customers but not much on the continual improvement from analysis of data.

10) If you're really hell-bent on abbreviating this Manual, technically, you don't need to include any of the rhetoric relating to the System Procedures. The Standard says:

The organization shall establish and maintain a quality manual that includes

a) the scope of the quality management system, including details of and justification for any exclusions (see 1.2),
b) the documented procedures established for the quality management system, or reference to them
c) a description of the interaction between the processes of the quality management system​

.​

You can just include a list of your "System Procedures", and refer to your "Quality Procedure Manual", as you have already done at the end of the document, under "Referenced Documents". That "rhetoric" then becomes a "prelude, or purpose" for the procedure. There's no need to put it in two places.

I understand this but did not want to eliminate the entire gist of the manual - just wanted to eliminate the repetitive wording that is restated with more detail in the procedures.

As a closet writer it pains me to remove as many words from the manual and I tend to agree with all of the posts about making it meaningless by just regurgitating the standard but as we are trying to reduce redundancy, and the maintenance of the system what is the real value of having a 54 page quality manual with 21 policies in it that no one ever looks at but me.

I told myself I'd limit this to 10 comments...so that's it...

Good Luck,
Patricia

Please feel free to continue to ask questions and make suggestions. I appreciate all of them.

 

[Tom W]

Hi Tom,
thanks a lot for sharing,
I have just given a look to your manual and I wondering why you didn't cite CQI-9 which, I suppose, is fundamental for You.

thanks

You are correct that it is a critical standard for us however we do not call it out as we also do not call out NADCAP; we develop our quality system to aling with all of the multiple standards we have in place. This is a good observation and one I shall consider; but as long as our system meets the requiremetns for CQI-9 through the structure of TS then I think we are covered as it is not a quality management system standard but more of a specific heat treat system standard related more to process control.

 

[Tom W]

Re: Looking for Input from TS Guru's

Hello Tom,

I totally agree with AndyN, using the format of the standard fulfilles it, but it normally doesn't fit your company. As hard as it is, these 8 pages will nobody read in your company.

If you rework it, then make it fit your company.

Take a look in the forum and you will find some good examples for process maps etc.

Regards,

TamTom

No one reads the 54 pages we currently have so that's the point of reduction - saves me in maintenace and upkeep.

 

[Patricia Ravanello]

Thanks to everyone that has taken the time to review and respond.

I think some clarification might be in order here.

I am looking to reduce the size of the quality manual; that’s it...nothing more.

I do appreciate all of the comments and I am definitely going to consider all of the comments and suggestions.

For comparison purposes I have attached a copy of two of the 21 policies that currently reside in our policy Manual. Please keep in mind that we have the traditional Level 1 Policy Manual; Level 2 Procedure Manual; and Level 3 Work Instructions all originally created back in 1999 under QS. The meat is in the procedures and work instructions. Our policies were set up to start the conversation about the topic then the procedures repeated most of that and added more substance to it.

Over the last 4 years or so when we have been audited none of the auditors even opened the quality manual; they jumped to the procedures where the detail is. This might be because of the maturity of the system or the familiarity of the auditors with our system.

My desire is to truncate the manual to reduce the documentation nightmare while streamlining our procedures to be more direct and informative rather than to cumbersome and wordy.

Thanks again and I look forward to more discussions - this is the best litmus test there is.

Hi Tom,

In light of your response, you can significantly reduce this document by doing what I suggested in 'No. 10" above, that is, remove all the discussion about the 21 policies (Procedures), since they serve no purpose in your "Policy Manual". Just ensure that you reference them in the "Policy Manual".

(Your comments and procedures include a rather unorthodox use of the word "Policy", but I suppose you should stick with whatever people have become familiar with.)

One last comment...Auditors don't typically need to review the "Policy Manual" since it's adequacy was determined at the Stage 1 Documentation Audit. They might use it to see if there are changes in the Company that can impact on the Audit...new manufacturing sites, supporting sites, storage sites, Management changes (per the Organizational Chart - is you Org Chart referenced in this Manual?), ownership changes, changes in the number of employees...new positions described on the Org Chart (often they'll go specifically to the changed areas, or audit personnel in new positions, to verify competence), etc.

I think you're on the right track.

Patricia

 

[zancky]

hi Tom again,
sorry but my post was not completed as I was urgently requested.
You said that in the last 4 years no auditor has probably checked/read your manual.
I had got the same feeling for my manual so I have asked the some CB auditors if it was so.
it is not because they trusted on your system maturity, it is a cost reduction, time is money and check the manual means time!
Well, they will say it is the first CB who had to check the manual, but normally they prefer to spend the too short time for auditing on checking how you operate.
I hope it is only my experience but ....