Interesting Discussion IATF 16949:2016 Clause 9.2.2.3 and Layered Process Audits

#1
We have a Layered Process Audit program in place for performing our manufacturing process audits (LPA is a customer-specific required approach). It does not specifically schedule or differentiate between production shifts. Clause 9.2.2.3 states that "Within each audit plan, each manufacturing process shall be audited on all shifts where it occurs".

We have a daily 1st layer audit for every cell, then each cell has a 2nd layer audit each month and a 3rd layer audit each quarter.
We primarily have 2 shifts of production (18 production cells), with three to four higher-volume cells running on a third shift.
We are trying to come up with an auditing schedule that will fulfill the "all shifts" requirement with our limited auditing resources.
For example, do the daily 1st layer audits need to actually be specified as "every shift", if all cells are subsequently audited at the 2nd and 3rd layers on all shifts?

Do all 18 cells need to have a 2nd layer (monthly) and 3rd layer (quarterly) audit done on every production shift for each layer interval, or is it sufficient to cover all shifts "over each three-year calendar period"?

Not all of our audit criteria are operator-specific, but that is the primary difference from one shift to another. For example, a gauge calibration is not likely to expire from 3rd shift to 1st shift, but a 3rd shift operator may not be trained to apply the control plan the same as a 1st shift operator, which would only be discovered by the LPA being performed across all shifts.
 
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#2
Pumped,

To answer this question you need to go back to this simplified definition of the Layered Process Audit.

Layered Process Audits are a quality technique that focuses on observing and validating how products are made, rather than inspecting finished products.

Some people refer to these audits as "policing" the process.

If you cannot verify that each shift is adhering to the same processes and standards, then how can you assure your customer (who is requiring this system be in place) that they are receiving the same quality process, producing the same quality product from each shift.

In short, YES if you have this in place for your 1st shift operation, you should have it in place for all other shifts producing the same parts or any other parts having the same requirement from your customer.

If not, you will have to explain yourself when the External Auditor comes-a-calling.

Hope this helps
 

morteza

Trusted Information Resource
#3
We have a Layered Process Audit program in place for performing our manufacturing process audits (LPA is a customer-specific required approach). It does not specifically schedule or differentiate between production shifts. Clause 9.2.2.3 states that "Within each audit plan, each manufacturing process shall be audited on all shifts where it occurs".

We have a daily 1st layer audit for every cell, then each cell has a 2nd layer audit each month and a 3rd layer audit each quarter.
We primarily have 2 shifts of production (18 production cells), with three to four higher-volume cells running on a third shift.
We are trying to come up with an auditing schedule that will fulfill the "all shifts" requirement with our limited auditing resources.
For example, do the daily 1st layer audits need to actually be specified as "every shift", if all cells are subsequently audited at the 2nd and 3rd layers on all shifts?

Do all 18 cells need to have a 2nd layer (monthly) and 3rd layer (quarterly) audit done on every production shift for each layer interval, or is it sufficient to cover all shifts "over each three-year calendar period"?

Not all of our audit criteria are operator-specific, but that is the primary difference from one shift to another. For example, a gauge calibration is not likely to expire from 3rd shift to 1st shift, but a 3rd shift operator may not be trained to apply the control plan the same as a 1st shift operator, which would only be discovered by the LPA being performed across all shifts.
Hi,

I think LPA and the requirement mentioned in clause 9.2.2.3 are two different items. LPA can not meet the process audit requirement (9.2.2.3).
LPA is done based on simple checklists which usually do not include any questions about PFMEA, while clause 9.2.2.3 states that manufacturing process audit shall include an audit of the effective implementation of the process risk analysis (such as PFMEA), control plan, etc. Normally, the LPA process does not verify the effective implementation of the PFMEA and control plan.

I think that LPA differs from the usual process audits such as heat treatment or plating processes audit which have their related CQIs. Also, in LPA the auditor is, for example, the production team leader which is not impartial.

Any other comment would be appreciated.
 
#4
Agreed, Morteza.
Clause 9.2.2.3 states that "Within each audit plan, each manufacturing process shall be audited on all shifts where it occurs".
It's entirely inappropriate to be referencing IATF (ISO) 16949 requirements for internal quality management audits, when considering referencing the scheduling of LPAs.

Do you have a copy of CQI-8?
 

Judegu

Starting to get Involved
#5
Hi,

I think LPA and the requirement mentioned in clause 9.2.2.3 are two different items. LPA can not meet the process audit requirement (9.2.2.3).
LPA is done based on simple checklists which usually do not include any questions about PFMEA, while clause 9.2.2.3 states that manufacturing process audit shall include an audit of the effective implementation of the process risk analysis (such as PFMEA), control plan, etc. Normally, the LPA process does not verify the effective implementation of the PFMEA and control plan.

I think that LPA differs from the usual process audits such as heat treatment or plating processes audit which have their related CQIs. Also, in LPA the auditor is, for example, the production team leader which is not impartial.

Any other comment would be appreciated.
Hi morteza. I have never had the opportunities to do LPA nor have I had the luck to see others doing it. Nevertheless I am quite curious about it because of the recommendation of using LPA as one way to do the process audit from IATF 16946.
So I have managed to find a copy of CQI-8 from the internet. In the document it is also said LPA can be deemed as a process audit. What is your opinion on this one?
Note: I totally agree with you on your undetstanding of LPA.
What is more, as you mentioned, the impatiality of LPA can not be 100 percent guaranteed. The auditor of LPA(at least in the tier 1) is the process owner himself. How can you manage to make LPA effective? I am quite curious about this one.
 

morteza

Trusted Information Resource
#6
Hi morteza. I have never had the opportunities to do LPA nor have I had the luck to see others doing it. Nevertheless I am quite curious about it because of the recommendation of using LPA as one way to do the process audit from IATF 16946.
So I have managed to find a copy of CQI-8 from the internet. In the document it is also said LPA can be deemed as a process audit. What is your opinion on this one?
Note: I totally agree with you on your undetstanding of LPA.
What is more, as you mentioned, the impatiality of LPA can not be 100 percent guaranteed. The auditor of LPA(at least in the tier 1) is the process owner himself. How can you manage to make LPA effective? I am quite curious about this one.
Hi,

I think you got old version of CQI-8 through internet. In 2005, AIAG in CQI-8 (layered process audit) mentioned that:
"Layered process audit can be considered a process audit as required by ISO/TS 16949:2002, section 8.2.2.2, manufacturing process audit"

Fortunately, this paragraph has been removed in 2nd edition (2014).
 

Howard Atkins

Forum Administrator
Staff member
Admin
#8
IATF has a number of differences in the manufacturing process audit clause fro the ISO/TS standard
9.2.2.3 Manufacturing process audit
The organization shall audit all manufacturing processes over each three-year calendar period to determine their effectiveness and efficiency using customer-specific required approaches for process audits- Where not defined by the customer, the organization shall determine the
approach to be used.
Within each individual audit plan, each manufacturing process shall be audited on all shifts where it occurs, including the appropriate sampling of the shift handover.
The manufacturing process audit shall include an audit of the effective implementation of the process risk analysis (such as PFMEA), control plan, and associated documents.


The requirements of FCA and GM to perform LPAs despite being in this clause does not include the highlighted part.
If you are performing one of the processes that requires a CQI audit, such as injection moulding then this is also part of the requirement for a manufacturing process audit.
As with the product audit there should be a definition in the documented audit process of the manner of performing the manufacturing process audit.
One of the continually found problems in IATF audits are the inconsistencies and errors in the CP and PFMEA, the normal excuse is the customer accepted it.
This is even when the wrong customer name is in the CP.
 

Judegu

Starting to get Involved
#9
Hi,

I think you got old version of CQI-8 through internet. In 2005, AIAG in CQI-8 (layered process audit) mentioned that:
"Layered process audit can be considered a process audit as required by ISO/TS 16949:2002, section 8.2.2.2, manufacturing process audit"

Fortunately, this paragraph has been removed in 2nd edition (2014).
Many thanks for your update on the new version of CQI-8. What about my second question? How do you gaurantee the effectiveness of Layer 1 audit where operators audits themself. How do you manage to make the result authentic? In my company, we also have similar self check process, sadly sometimes the operators just fill the check sheets without actually checking the items.
 
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