Definitive Understanding of 8.2.2.3 Manufacturing Process Audit

[pinpin - 2009]

The standard does not give any guidance. But I will share my preferences, based on many audits of how lots of companies do it. The TS standard defines 3 different levels of auditing. Since they went to the trouble of actually iidentifying them as 3 different sub-clauses, it is safe to assume they were actually looking for 3 different kinds or degrees of audits. Here's how I describe it.

8.2.2.1 The system processes must be audited, in a process approach. This includes core processes, support processes, all of them. If your system identifies 16 processes, I would expect to see internal audits of all 16. Review the metrics, criteria, inputs/outputs...audit the process and all the links to supporting processes.

8.2.2.2 This is a more detailed, ground level audit of each manufacturing process (or sub-process). For example, if you stamp, weld, paint and assemble, that would be 4 mfg. process audits. Most people use this opportunity to walk the control plan in great detail. Check each step, the gages, inspections, control specs, reaction plans, FMEA, process map, etc. This is one of the few times you will actually get to that level of detail. Take advantage of it. Some peole will even do that to each press line or work station. It depends how many you have. There is nothing that says you have to do them all in 1 year.

8.2.2.3 This is frequently addressed by the regular floor inspections, Q-lab verifications, First Article verifications, Annual Layouts, Dock Audits. Some people also tood in the Chrysler Layered Audits, if they do them.

Let me repeat, the standard does not specify exactly how these must be done. What I described is a common approach, but I am sure there are other approaches as well.

Dear Helmut Jilling,

First of all, I would like to thank you for your dedication and detailed explanation...

I have some questions, hope you teach me:

1) Under clause 8.2.2.1, the system is formed by many processes. Some suggest to list them in a matrix with all the applicable TS Clauses identified, then when we do systems audit of each process, we shall make sure all these identified clauses are audited (with evidience indicated in Turtle Diagram or audit check list that normally used in ISO 9001? Turtle Diagram doesn't seem to have enough space for recording information...can we don't use it as long as our checklist showing those items listed in turtle diagram? )? I think we may not have time to check all the clause requirements.....can we only audit some, base on status and importance....is it ok and acceptable by TS auditor?

2) Under clause 8.2.2.2, a manufacturing process may have many subprocesses within it, though some say these subprocesses are "steps" and not required to be audited but only the process, but if not audit these "steps" how can we say we have audited the process that make up by them (these steps)? TS does not specify when to do manufacturing process audit, since a company may not have many manpower to do audit, but as long as they do at least one audit throughout the entire time when the process is running (before it ceased to operate because no more orders require it to be run. Sometime, the order is too little and may just stop within 1-2 days before audit can be done...), is it accceptable to TS auditor? If not, what reason and what criteria in TS standard says it is noncompliant?

Is it all the steps listed in control plan must be audited in order to meet clause 8.2.2.2's "...each manufacturing process..." requirement?

3) Instead of having diffrent timing doing product audit, is it more effective to do product audit at the same time while doing manufacturing process audit? I look at it this way, product is the output of process, if we do not look at the product and the process generating it at the same time doing audit, we may not be able to readily identify weaknesses in the process while we discover defects in the product. Is it correct?

clause 8.2.2.3 says "....at a defined frequency", is it acceptable to do at least one audit (same reason as I said for manufaturing process above)?

Looking forward to hear from your views and teaching..........

 

[Helmut Jilling]

Dear Helmut Jilling,

First of all, I would like to thank you for your dedication and detailed explanation...

I have some questions, hope you teach me:

1) Under clause 8.2.2.1, the system is formed by many processes. Some suggest to list them in a matrix with all the applicable TS Clauses identified, then when we do systems audit of each process, we shall make sure all these identified clauses are audited (with evidience indicated in Turtle Diagram or audit check list that normally used in ISO 9001? Turtle Diagram doesn't seem to have enough space for recording information...can we don't use it as long as our checklist showing those items listed in turtle diagram? )? I think we may not have time to check all the clause requirements.....can we only audit some, base on status and importance....is it ok and acceptable by TS auditor?

That matrix is in the TS Rules book. It is a tool to keep track of which clauses and links should be reviewed when auditing a process. You should try to check all of them, but the amount of depth you go in each one, would depend on how important it is.

2) Under clause 8.2.2.2, a manufacturing process may have many subprocesses within it, though some say these subprocesses are "steps" and not required to be audited but only the process, but if not audit these "steps" how can we say we have audited the process that make up by them (these steps)? TS does not specify when to do manufacturing process audit, since a company may not have many manpower to do audit, but as long as they do at least one audit throughout the entire time when the process is running (before it ceased to operate because no more orders require it to be run. Sometime, the order is too little and may just stop within 1-2 days before audit can be done...), is it accceptable to TS auditor? If not, what reason and what criteria in TS standard says it is noncompliant?

Is it all the steps listed in control plan must be audited in order to meet clause 8.2.2.2's "...each manufacturing process..." requirement?

You should audit each subprocess, but, if you walk through all the important items on the control plan, as I previously suggested, then you will cross through each subprocess. As to scheduling, that is up to you to figure out how to do it. I would recommend each manufacturing process should be audited as least once per year. If it is not robust, it should be more frequent. TS standard does not go into any detail, so you have to decide what is appropriate.

3) Instead of having diffrent timing doing product audit, is it more effective to do product audit at the same time while doing manufacturing process audit? I look at it this way, product is the output of process, if we do not look at the product and the process generating it at the same time doing audit, we may not be able to readily identify weaknesses in the process while we discover defects in the product. Is it correct?

clause 8.2.2.3 says "....at a defined frequency", is it acceptable to do at least one audit (same reason as I said for manufaturing process above)?

Looking forward to hear from your views and teaching..........

Some companies do these two at the same time. More often, the product audit is done by shop floor inspectors, and the timing is based on when the product is run. The mfg. process audit is usually done by trained auditors.

 

[Duke Okes]

I would occassionally take a control plan and walk it thru. Then later, do the same thing on another product and/or line. Depending on how many products/lines you have might impact how often you do these audits.

 

[pinpin - 2009]

Some companies do these two at the same time. More often, the product audit is done by shop floor inspectors, and the timing is based on when the product is run. The mfg. process audit is usually done by trained auditors.

Dear Helmut Jilling, is it also to apply "process" auditng method with Turtle Diagram when doing Product Audit?

Duke Oke, your said "I would occassionally take a control plan and walk it thru. Then later, do the same thing on another product and/or line. Depending on how many products/lines you have might impact how often you do these audits.". Do you use Turtle Diagram as a checklist to fill out findings/audit evidence besides the control plan?

Can you show me a sample of each type of these audit (systems, manufacturing process and product)?

 

[Helmut Jilling]

Dear Helmut Jilling, is it also to apply "process" auditng method with Turtle Diagram when doing Product Audit?

Duke Oke, your said "I would occassionally take a control plan and walk it thru. Then later, do the same thing on another product and/or line. Depending on how many products/lines you have might impact how often you do these audits.". Do you use Turtle Diagram as a checklist to fill out findings/audit evidence besides the control plan?

Can you show me a sample of each type of these audit (systems, manufacturing process and product)?

Some people use Turtles to record evidence during an audit. That is OK, but I do not recommend it.

I like Turtle Diagrams as a way to describe a process. I think they are useful, if done correctly. But, once you have filled it out, I recommend making it part of the procedure for that process. Why fill it out again and again with the same information. Why not just take the official one, already filled out, and verify that the information on it is still being followed?

Spend your time interviewing and evaluating, and less time writing redundant information.

 

[Jan T]

Hi pinpin;

We have basically one manufacturing process, we are contract electroplaters.
What I do is audit each line that is running (as we do different finishes
on different lines) at various times throughout the year. I determine the audit schedule based on the volume that is processed on the line, also taking into consideration if there have been any NCRs generated for parts processed on the line. These I will audit more frequently than others.

Jan

 

[mindy463 - 2008]

The way we interpret it in our facility is each (individual)control plan is audited, line by line. Much in the same manner that Ford and GM audit during launch readiness.

 

[pinpin - 2009]

Hi pinpin;

We have basically one manufacturing process, we are contract electroplaters.
What I do is audit each line that is running (as we do different finishes
on different lines) at various times throughout the year. I determine the audit schedule based on the volume that is processed on the line, also taking into consideration if there have been any NCRs generated for parts processed on the line. These I will audit more frequently than others.

Jan

Dear Jan, thank you! I agree with your ways.

 

[world quality]

Process audits are a little more detailed if TS than ISO but I still use and require the same for both.

Jan, is a electro plater does she also comply with AIAG CQI 11 for plating.

Please see files attached.

 

[Helmut Jilling]

The way we interpret it in our facility is each (individual)control plan is audited, line by line. Much in the same manner that Ford and GM audit during launch readiness.

This "walking the control plan" is the best approach of the various methods I have seen.