Can anyone help me differentiate among the System/proces/product audit ?

Rocky

Can anyone help me differentiate among the System/proces/product audit ?

Rocky

The System audit is an audit of the entire Quality Management System (QMS). This determines Conformance to the 16949 (or other) Standard. These audits are typically the ones your registrar does for certification. You or a customer might do these audits as well when evaluating the entire QMS.

A process audit is an in-depth look at a single process. For example, you may want to audit the purchasing process. You would review that process and the interaction it has with other processes. The scope of these process audits will define the areas of your company that will be audited. These are typically done by your internal audit group.

Product audits are looking at a specific part or product. They are sometimes called "trace" audits. The audit starts at receiving and follows that particular part through the entire process to delivery to the customer. This audit is called a "Forward Trace" audit. You could start from the other end and go in reverse to track all the steps the part actually went through to the point of receipt. This would be a "Backward/Reverse Trace" audit. These audits are generally done to evaluate the flow of a single part. Customers often want to do a product audit on one of their parts.

Hope this helps.

Dave

My understanding of process audit is auditing the manufacturing process. Control Plan, operator instructions, kan bans, data collection, etc.

Quality system audit is by auditing the all the different processes (turtles) through the course of the year/schedule.

During Mgmt Review you are looking at the "whole" system and its effectiveness.

Can anyone help me differentiate among the System/proces/product audit ?

Rocky

If you do a search on the Cove, we have discussed this a lot in the past. Remember, internal and external audits in TS require a process approach. This applies to system audits as well.

Hi, I have always considered the following to satisfy the 8.2.2 Internal Audit requirements. These have been acceptable to our external auditors.

8.2.2.1 Quality Management System Audit
These are the internal audits of the entire quality system which are similar to which your registrar auditors do.

8.2.2.2 Manufacturing Process Audits
These are the audits on your individual manufacturing processes. If you look at Section 3.0, Terms and Definitions, Manufacturing is described as the process of making or fabrication. So a detailed audit of a particular manufacturing process (e.g assembly stage) taking into account the control plan.

8.2.2.3 Product Audits
These are looking at auditing the 'Product' at particular points of the production. Does it meet the specifications required. So this might be similar to an 'Out of Box' audit at the end of production.

Remember to satisfy the requirements of 8.2.2.4 these must be covered across all shifts. And yes, they must follow the 'Process Approach'

Hope this helps :)

I want to note that our 3rd party auditor stated that daily dock audits and quality checks called out on control plan do not suffice for product audits.

Last year we performed product audits on each of our finished products once every 2 months. Due to the good results last year, we have changed it to every 4 months.

I want to note that our 3rd party auditor stated that daily dock audits and quality checks called out on control plan do not suffice for product audits.

Last year we performed product audits on each of our finished products once every 2 months. Due to the good results last year, we have changed it to every 4 months.


Not sure why he/she would state that. I know of no guidance that mandates that interpretation. I think the approach you stated could clearly meet the requirement, if done correctly and the results support it.

I want to note that our 3rd party auditor stated that daily dock audits and quality checks called out on control plan do not suffice for product audits.

Last year we performed product audits on each of our finished products once every 2 months. Due to the good results last year, we have changed it to every 4 months.


I have heard similar. If you are simply checking product features etc., then I could see a case for such a comment. Product audits are not just 'product' - typically you should look at packaging, dunnage, labelling, delivery requirements, etc. The challenge is to avoid stepping over the (fine) line and turning it into an audit of the manufacturing process......Oh, and of course the product audit should also include functionality (if that's not covered by the inspections/tests)

Andy

I have heard similar. If you are simply checking product features etc., then I could see a case for such a comment. Product audits are not just 'product' - typically you should look at packaging, dunnage, labelling, delivery requirements, etc. The challenge is to avoid stepping over the (fine) line and turning it into an audit of the manufacturing process......Oh, and of course the product audit should also include functionality (if that's not covered by the inspections/tests)

Andy


agree. It may be appropriate to point out that the TS standard is rather vague on what is expected on these types of audits. Consequently, would it be fair to suggest that if the standard is vague, perhaps it wants to allow a measure of flexibility in how to implement?

I have a question about how to eliminate the incoming inspection if we are a manufacturing company that deals with different size suppliers?
Thank you in advance

I have a question about how to eliminate the incoming inspection if we are a manufacturing company that deals with different size suppliers?
Thank you in advance

One place to begin would be to evaluate which suppliers are consistently shipping excellent product. If you are confident they will continue to ship excellent quality, and if any defect would be discovered later within your system, those might be candidates for eliminating or reducing receiving inspection. However, if a select supplier begins to ship defects, then for a time it would be approrpiate to resume receiving inspection.

One place to begin would be to evaluate which suppliers are consistently shipping excellent product. If you are confident they will continue to ship excellent quality, and if any defect would be discovered later within your system, those might be candidates for eliminating or reducing receiving inspection. However, if a select supplier begins to ship defects, then for a time it would be approrpiate to resume receiving inspection.


I have worked for a company in the past who ranked their suppliers with a Red, Yellow or Green rating system.
Green suppliers were ones who had never had a quality defect that affected us, or our customer. The majority of these suppliers were screws, bolts, adhesives etc. These suppliers required no incoming inspection beyond the receiving department confirming part number and quantity.
Yellow suppliers were suppliers who maybe had minor problems in the past, but their problems were caught by our assembly process and had no possibility of being passed to our customer. These parts required a minimum level of inspection, usually < 1% per each supplier lot date.
Then you had the Red suppliers. They were classified as Red because they either had frequent minor issues, or any major issues. A supplier could also be classified as Red if their defects could make it out of our plant and detected by the customer. Red suppliers were given higher inspection rates based on the severity of their problems. Some were 20% all the way up to 100% receiving inspection.
Suppliers were audited anually and it was determined whether thier performance over the previous year would keep their ranking at the same level, moved up or moved down.

I have worked for a company in the past who ranked their suppliers with a Red, Yellow or Green rating system.
Green suppliers were ones who had never had a quality defect that affected us, or our customer. The majority of these suppliers were screws, bolts, adhesives etc. These suppliers required no incoming inspection beyond the receiving department confirming part number and quantity.
Yellow suppliers were suppliers who maybe had minor problems in the past, but their problems were caught by our assembly process and had no possibility of being passed to our customer. These parts required a minimum level of inspection, usually < 1% per each supplier lot date.
Then you had the Red suppliers. They were classified as Red because they either had frequent minor issues, or any major issues. A supplier could also be classified as Red if their defects could make it out of our plant and detected by the customer. Red suppliers were given higher inspection rates based on the severity of their problems. Some were 20% all the way up to 100% receiving inspection.
Suppliers were audited anually and it was determined whether thier performance over the previous year would keep their ranking at the same level, moved up or moved down.


That sounds like a very good approach. I like it, though I would recommend one important change. The annual review is appropriate, but I think a green or yellow supplier should immedately lose their favored status (temporarily) when you experience quality issues. To keep with the intent of the standard, favored status should only be maintained when their current performance justifies it.

thanks a lot for your answer

thank you so much all

That sounds like a very good approach. I like it, though I would recommend one important change. The annual review is appropriate, but I think a green or yellow supplier should immedately lose their favored status (temporarily) when you experience quality issues. To keep with the intent of the standard, favored status should only be maintained when their current performance justifies it.

Point well taken.
I think we kind of informally did that, but it would be a good idea to make it a part of the documented procedure.

I want to note that our 3rd party auditor stated that daily dock audits and quality checks called out on control plan do not suffice for product audits.

Last year we performed product audits on each of our finished products once every 2 months. Due to the good results last year, we have changed it to every 4 months.

We have had the same finding. If it is a regular check called out on the control plan it is not a product audit. We had included our daily shiftly quality audits and annual layouts as part of product audits. It was fine for 3 years but then our new auditor didn't buy it.

Originally Posted by sora142

I have a question about how to eliminate the incoming inspection if we are a manufacturing company that deals with different size suppliers?
Thank you in advance

we rate our suppliers quarterly with an A,B,C,D rating. If the supplier is D for one quarter or C for the entire year, they must implement containment actions and certify all stock coming to our facility. We implement receiving inspection, but only to check that the incoming parts are certified and perhaps a spot check of some parts if necessary. Otherwise for A and B suppliers we do not do any receiving inspection unless they have a quality issue with a part.

We too perform product audits on our products as per the ISO/TS requirement ie packaging, labelling, dimension functionality...
We sample products at particular points along the process flow and yearly our Internal Auditors perform an audit to ensure the product audit is performed per the respective process procedures.
Then here comes a customer ( Not an automotive customer) and their intrpretation is that if a company is certified ISO/TS, then product audit SHALL be performed for all products irrespective whether the product is automotive or not.
Another intrepretation of the Product Audit, especially for semiconductor suppliers is that even the wire size, die dimension, leadframe dimension is required to be audited, when the ISO/TS is very clear on packaging, labelling, dimension and functionality.

Athies,

What i can understand from your statement is that , if we audit product at all production stages (including FG shipping etc) (Here by QC) and during internal quality audit we check whether we are following the checkpoints at each stage is good enough to qualify for compliance with TS requirement.

:confused:

Rocky

Athies,

What i can understand from your statement is that , if we audit product at all production stages (including FG shipping etc) (Here by QC) and during internal quality audit we check whether we are following the checkpoints at each stage is good enough to qualify for compliance with TS requirement.

:confused:

Rocky

No. Not the requirement for TS. Product audit is of the finished product...above and beyond all other conformance checks called out in your process documentation. And not a dock audit either. And not annual layout either. The frequency can be very low if you can provide evidence to support it.

Can anybody explain me the difference between "system audit" in production and "process audit" in the same production (production processes)? Is it the same audit or really different?

Can anybody explain me the difference between "system audit" in production and "process audit" in the same production (production processes)? Is it the same audit or really different?


If you do a search on the Cove, we have discussed this a lot in the past. Remember, internal and external audits in TS require a process approach. This applies to system audits as well. Also, there are good comments earlier in this thread in post number 2.

For now, the two audits are not the same, or they would not have had any reason to list it under a separate clause number. They obviously intended a different approach.

The System Audit audits each process you have defined in your quality manual (cl. 4.1, 4.2). The audits are performed to a process approach, which would include the inputs, outputs, criteria, metrics, objectives & targets, sequence of the process, effectiveness and linkages to other processes. This would include auditing your manufacturing processes in this manner.

The manufacturing audits are not described in any detail. So, apparently they want to allow you a lot of leeway. Most of my clients do a thorough audit of the control plan for each process, checking all the details and gages, etc. on the control plan. This is not the only acceptable approach, but might be a good start.

This is the way I learned it and has been passing audits:

Your quality management system is defined in terms of the individual processes that make up the "entire" process. (APQP, Supplier Development/Purchasing, Receiving Inspection, Receiving, Calibration/MSA, Production of Goods, etc.)

Now for the internal auditing:

-Internal quality system audits
Auditing the quality system (see above) (that is where the word "process" is applied to this type of auditing)

-Process audits (can be combined with layered process audits)
This is auditing the manufacturing processes on the floor (production of goods) (Control Plans, Operator Instructions, Kan ban, etc.) (This is where the word "process" is used again but for a different type of auditing)

-Product audits
Product audit is of the finished product...above and beyond all other conformance checks called out in your process documentation (We just set-up canned checklists derived from the part print - every single dimension does not have to be captured - that is the annual layout

-Dock audit
Sampling of product staged on the dock (I create "hot lists" for our inspector to focus on determined by current quality issues)

This is the way I learned it and has been passing audits:

Your quality management system is defined in terms of the individual processes that make up the "entire" process. (APQP, Supplier Development/Purchasing, Receiving Inspection, Receiving, Calibration/MSA, Production of Goods, etc.)

Now for the internal auditing:

-Internal quality system audits
Auditing the quality system (see above) (that is where the word "process" is applied to this type of auditing)

-Process audits (can be combined with layered process audits)
This is auditing the manufacturing processes on the floor (production of goods) (Control Plans, Operator Instructions, Kan ban, etc.) (This is where the word "process" is used again but for a different type of auditing)

-Product audits
Product audit is of the finished product...above and beyond all other conformance checks called out in your process documentation (We just set-up canned checklists derived from the part print - every single dimension does not have to be captured - that is the annual layout

-Dock audit
Sampling of product staged on the dock (I create "hot lists" for our inspector to focus on determined by current quality issues)

Could you shed some light on these points:-

What is the rationale behind doing 'dock audits' and 'product audits'?

How do you combine LPA with auditing the manufacturing process?

Thanks!

What is the rationale behind doing 'dock audits' and 'product audits'?

At the time of our registration audit it was our belief that our dock audits would suffice for product audits. But our registrar said that product audits had to be "above and beyond" anything that was part of our normal quality checks. In hindsight (at this very moment) dock audits are not documented in our control plans so it already was above and beyond. Maybe it had something to do with the fact that the IAOB was auditing our registrar at the same time?!

I believe dock audits are even more a misuse of time and energy over incoming inspection (when there are no supplier issues) but our inspector has caught nonconformances about 3-4 times over the last two+ years on the dock. Go figure.

How do you combine LPA with auditing the manufacturing process?

Combining them was in effort to keep our quality system from growing beyond control. We originally where doing them separate. I had a technician that was performing the regular process audits but we had to drop him out of our salary headcount because reductions in Ford/DCX production. The supervisors where already doing layered audits every shift - so I added the process audit checks (control plan, 5S, PM, etc) to their existing layered audit checksheets. Note that our original layered process audits where bare bones. And there was obvious overlap.

Whew! I'm happier to read that you see the dock audits as a bit of 'overkill'. Having been responsible for them too, I made sure there was a blended approach so that the dock audits were part of the product audit, but not exclusively done that way.

IMHO, I don't see how LPA's can be a substitute for a process audit of a manufacturing process, since, even with the control plan, etc., a) the auditors aren't ususally trained on the core tools (SPC comes to mind) and b) a process approach must include many other items not usually covered in the CP etc or in the LPA approach...........even tho' the AIAG guidelines say you can substitute LPA for this............:yuk:

You only have to have trained auditors for internal quality system audits. All other internal audits (process, product) do not require a certificate. But you must be able to demonstrate that those who audit process & product are very familiar - goes w/ out saying.

Yeah - that's really scary................:mg:;)

For now, the two audits are not the same, or they would not have had any reason to list it under a separate clause number. They obviously intended a different approach.

The System Audit audits each process you have defined in your quality manual (cl. 4.1, 4.2). The audits are performed to a process approach, which would include the inputs, outputs, criteria, metrics, objectives & targets, sequence of the process, effectiveness and linkages to other processes. This would include auditing your manufacturing processes in this manner.

The manufacturing audits are not described in any detail. So, apparently they want to allow you a lot of leeway. Most of my clients do a thorough audit of the control plan for each process, checking all the details and gages, etc. on the control plan. This is not the only acceptable approach, but might be a good start.

Some firms perform system audits and process audits (in production area) in the same way, using of course process approach which include the inputs, outputs, criteria, metrics, objectives & targets, sequence of the process, effectiveness and linkages to other processes, and of course control plan, fmea analysis, flow-charts, work instructions. And then they say "Why do we need separate system audit and process audit in production? Let's integrate them". In the end - they have one audit in production (for system and process). My question - Do they implement/fulfil TS requirements (8.2.2.1and 8.2.2.2)?

You only have to have trained auditors for internal quality system audits. All other internal audits (process, product) do not require a certificate. But you must be able to demonstrate that those who audit process & product are very familiar - goes w/ out saying.

Well. A lot of CB auditors say that all internal auditors shall be qualified so company shall establish minimum qualification requirements for system/process/product auditors. It usually includes training. I remember the events CB auditors notified nonconformities in cases - process/product auditors weren't trained.

Hi AndyN.
Thanks for the explanation. By the way what is your product that your company manufactures?
We manufacture and test semiconductor parts. Every single unit is tested on million dollar testers. Do we still have to do functionality?
I do not see a good reason for this.
Some of my customers are telling us that we need to to look at their test programs and audit the testers to see if we are following the limits set by them.
This does not make sense to us as "functionality" to us is the part should be tetsed in the "application". Eg, for mechanical parts such as hinges, wud u consider that by measuring the hinge against the customers drawing as "functionality" ?

I'm really at wits end. I have been debating the issue of why we are performing forty four (44) product audits a week. There are so many repeats between machines and operators, it isn't funny. Manufacturing is also doing the same audits every day. Help. Amount is too much for a company of 100 people. three shifts. Any suggestions?

I'm really at wits end. I have been debating the issue of why we are performing forty four (44) product audits a week. There are so many repeats between machines and operators, it isn't funny. Manufacturing is also doing the same audits every day. Help. Amount is too much for a company of 100 people. three shifts. Any suggestions?

Yup, Rich, that is waaaaay too much for a small company. What do you mean when you say 'repeats'? It would help to know what you're talking about here, before we can answer exactly.

When setting up a product audit schedule, I chose those items which had been a problem with customers, (first) followed by those which had been found during 'safe launch' or were new products. We did them weekly and, depending on what was the reason for the associated issues, like mislabeling, we did the audits close to the area that 'caused' the problem.

I'm really at wits end. I have been debating the issue of why we are performing forty four (44) product audits a week. There are so many repeats between machines and operators, it isn't funny. Manufacturing is also doing the same audits every day. Help. Amount is too much for a company of 100 people. three shifts. Any suggestions?


That sounds like a lot! Why are you doing so many? How is your quality performance running? PPM?

Some firms perform system audits and process audits (in production area) in the same way, using of course process approach which include the inputs, outputs, criteria, metrics, objectives & targets, sequence of the process, effectiveness and linkages to other processes, and of course control plan, fmea analysis, flow-charts, work instructions. And then they say "Why do we need separate system audit and process audit in production? Let's integrate them". In the end - they have one audit in production (for system and process). My question - Do they implement/fulfil TS requirements (8.2.2.1and 8.2.2.2)?


If they are just sampling some items in production, it might not meet the requirement. If they are thoroughly walking a control plan or flowchart, might be ok...



Well. A lot of CB auditors say that all internal auditors shall be qualified so company shall establish minimum qualification requirements for system/process/product auditors. It usually includes training. I remember the events CB auditors notified nonconformities in cases - process/product auditors weren't trained.


There was an official answer that product auditors would not necessarily have to be fully trained, competent internal auditors.

There was an official answer that product auditors would not necessarily have to be fully trained, competent internal auditors.
Thank you. What source of this official answer?

Thank you. What source of this official answer?


Unfortunately, I do not recall...sorry.

hello Guys

I'm new to this site, I enjoy reading all the wonderful great information.

Do any body know or have a product-audit checklist that could see or review for ideas on how to do one at our facility. I work for the aerospace industry.

Thanks

hello Guys

I'm new to this site, I enjoy reading all the wonderful great information.

Do any body know or have a product-audit checklist that could see or review for ideas on how to do one at our facility. I work for the aerospace industry.

Thanks

Welcome to The Cove Forums! :bigwave: :bigwave:

What Standard applies to your organization?

Stijloor.

Hi every body...

System Audit is the audit of quality system to check whether the system fulfills the requirements of ISO Standards.The audit could be from top management to all depts.

Process audit will be carried out to ascertain the effectiveness of various process .

Product audit will be carried out on the product,this is normally carried out after the product is ready,and any non conformance thus noticed will ensure even the product being recalled.whereas process audit will improve the product .:)

Thank you for your response.
The Standards that apply to my company is AS9100.
If you know any procedure or checklist to start my development of a product audit, will be great.

Hi every body...

System Audit is the audit of quality system to check whether the system fulfills the requirements of ISO Standards.The audit could be from top management to all depts.

Process audit will be carried out to ascertain the effectiveness of various process .

Product audit will be carried out on the product,this is normally carried out after the product is ready,and any non conformance thus noticed will ensure even the product being recalled.whereas process audit will improve the product .:)

Thanks.

This is my first post. I have been reading and learning a lot from your discussions the past years. Thanks to all.

With regard to internal audits, is it required to have internal auditors trained by a trainor whose qualification is traceable to an accredited course? Would the CBs require some form of record o enable traceability? Or could internal auditors be trained by a trainor who has attended an ISO 9001 lead assessors' course?

Thanks.

This is my first post. I have been reading and learning a lot from your discussions the past years. Thanks to all.

With regard to internal audits, is it required to have internal auditors trained by a trainor whose qualification is traceable to an accredited course? Would the CBs require some form of record o enable traceability? Or could internal auditors be trained by a trainor who has attended an ISO 9001 lead assessors' course?

Hello Raymond,

Welcome (back) to The Cove Forums! :bigwave: :bigwave:

From you profile, I learned that you posted before (21st August 2006). :D

You posted your question in an ISO/TS 16949:2002 thread. But is ISO 9001 the Standard you are referring to? If so, there are no specific qualification requirements for the person who trains internal auditors, other than that this person must be competent to do so.

However, for ISO/TS 16949, some Customers (i.e: Ford Motor Company) have specific training and trainer requirements spelled out in their Customer-Specific Requirements.

Hope this helps.

Stijloor.

Thanks Stiljoor.

I am referring to the ISO/TS16949 standard. I would have to review our customers' specific requirements in more detail. Most Japanese car manufacturers do not specify requirements on internal audit trainings or internal auditors' competence.

Thanks Stiljoor.

I am referring to the ISO/TS16949 standard. I would have to review our customers' specific requirements in more detail. Most Japanese car manufacturers do not specify requirements on internal audit trainings or internal auditors' competence.

Great! Then you decide! Remember that training is provided to enhance competencies and you must verify the effectiveness of the internal auditor training.

Stijloor.

Thanks.

This is my first post. I have been reading and learning a lot from your discussions the past years. Thanks to all.

With regard to internal audits, is it required to have internal auditors trained by a trainor whose qualification is traceable to an accredited course? Would the CBs require some form of record o enable traceability? Or could internal auditors be trained by a trainor who has attended an ISO 9001 lead assessors' course?


If you are a supplier to Ford, they have listed specific training requirements for the trainer in their CSR. Otherwise, any competent training in a process approach method could satisfy the requirement. But, good training can be beneficial.

My understanding of process audit is auditing the manufacturing process. Control Plan, operator instructions, kan bans, data collection, etc.

Quality system audit is by auditing the all the different processes (turtles) through the course of the year/schedule.

During Mgmt Review you are looking at the "whole" system and its effectiveness.

I would have to disagree with this. Focus on production processes in process audits is insufficient. A process can be defined as a systematic series of actions. Your turtles are most definitely processes.

I would have to disagree with this. Focus on production processes in process audits is insufficient. A process can be defined as a systematic series of actions. Your turtles are most definitely processes.


I think you are partly correct. Auditing in a process approach clearly is not limited to production processes. A process approach should be applied to all processes - Purchasing, Engineering, Maintenance, etc., not just Manufacturing.

Turtle diagrams, or flowcharts, procedures, etc. are not processes themselves, they are documents that can be used to describe processes. They are useful to usewhen auditing each process.

Auditing each manufacturing process by walking through the control plan is a very effective and widely accepted method of doing the production process audits.

Hi, I have always considered the following to satisfy the 8.2.2 Internal Audit requirements. These have been acceptable to our external auditors.

8.2.2.1 Quality Management System Audit
These are the internal audits of the entire quality system which are similar to which your registrar auditors do.

8.2.2.2 Manufacturing Process Audits
These are the audits on your individual manufacturing processes. If you look at Section 3.0, Terms and Definitions, Manufacturing is described as the process of making or fabrication. So a detailed audit of a particular manufacturing process (e.g assembly stage) taking into account the control plan.

8.2.2.3 Product Audits
These are looking at auditing the 'Product' at particular points of the production. Does it meet the specifications required. So this might be similar to an 'Out of Box' audit at the end of production.

Remember to satisfy the requirements of 8.2.2.4 these must be covered across all shifts. And yes, they must follow the 'Process Approach'

Hope this helps :)

Yes... You are absolutely right ..

jhonie