2021 is over.  Let’s take a look back at the top 10 major nonconformities identified during 3^rd party IATF audits in 2021 to better understand areas of the QMS in which automotive manufacturers seem to struggle most, which will give us some insight on areas in which we need to focus to improve skills, capability, and understanding to better meet these requirements in the industry as a whole.

1. 10.2.3 Problem-solving – this comes as no surprise as this is typically the largest major nonconformity found in IATF audits, year-after-year.  The IAOB commenters correctly note that the problem-solving requirements do not only apply to customer complaints, but to issues found internally as well.  It’s evident that we should be training teams and individuals within our organizations on how to lead problem-solving initiatives to truly understand root causes of problems so that recurrence can be prevented.
2. 10.2.1 Nonconformity and corrective action – there are no supplemental requirements here, with all the requirements coming directly from ISO 9001:2015, but it’s still one of the largest areas in which automotive manufacturers struggle and it’s closely related to the #1 spot – we just don’t seem to understand how to dig down to the root cause of problems that we encounter so that effective corrective actions can be employed to truly put them to bed.
3. 8.3.5.2 Manufacturing process design output – it seems that most findings noted against 8.3.5.2 reflect issues with the PFMEA, which would be one of the most important outputs of the manufacturing process design.  From my experience, auto manufacturers really struggle to use PFMEA as in intended in the APQP process to truly anticipate failure modes and mitigate risks, instead, frequently working backwards to add items into the PFMEA after the failure modes that were not considered have occurred.  When looking at this from that angle, it’s no surprise that it’s so high on the list.
4. 8.5.1.1. Control plan – The commenters here correctly note that the control plan is one of the most important documents as it dictates what is being done and how products are produced, and they speculate that most of the findings against 8.5.1.1 are related to the failure to keep these documents as live documents that are regularly updated to reflect current practices.  If you’re sitting on a pile of redlined control plans that don’t exist in any controlled format and aren’t available to the people executing the process in question, we’re talking to you.
5. 7.1.5.1.1 Measurement system analysis – Here, it seems that most of the findings listed against 7.1.5.1.1 are coming from a skills gap where manufacturers – and auditors – are not confident in MSA requirements or the activities needed to assess the statistical repeatability and reproducibility of the measurement results of a given measurement system.  It’s clear from the data that we need to be spending more time training and instilling the technical aspects of the industry to help to close this skills gap and ready the next generation to truly understand and qualify their measurement systems.
6. 8.5.1 Control of production and service provision – again, this is a carry over from ISO 9001 without any additional supplementary requirements for IATF 16949, but it still sits high on the list of major nonconformities for auto manufacturers.  It seems that this is highly related to control plan deficiencies, but on a more systemic level in which the problems are not associated with not keeping the control plans updated, but, rather, with having the necessary discipline to follow and train to control plans that have been established.  If you’re in Operations and are throwing whatever labor you have available on a line to keep it running with no respect to how the process was designed, you’re probably contributing to this metric.
7. 9.1.1.1 Monitoring and measurement of manufacturing processes – this seems to be primarily reflective of poor APQP disciplines for auto manufacturers and consistent with findings regarding poorly implemented Process Flow Diagrams, PFMEAs, and Control Plans, and a general inability to properly identify places where things like process capability should be regularly monitored.
8. 4.3.2 Customer specific requirements – while there isn’t a lot of detail about which CSRs are prompting the findings that are placing this on the top 10 major nonconformity list, the commenters note how the addition of CSRs above the supplemental requirements of IATF 16949 seem to frequently muddy the waters for manufacturers, noting that they are an “increasing burden”, and they speculate – and we’re hoping that they are correct – that there will be a lot of efforts to harmonize CSRs in the future, which will reduce complexity for manufacturers and make it easier to meet the IATF requirements.  Why are we allowing for each OEM to add their own requirements on top of the standard IATF requirements anyway?
9. 9.1.2.1 Customer satisfaction – supplemental – It comes as no surprise at all to me that this is in the top 10; the real surprise is that it is not higher on the list.  IATF has narrowed its focus to rely more on OEM feedback to ensure that IATF certified companies are truly producing and delivering parts that meet customer requirements, which should go without saying, but with the increased focus on customer satisfaction within IATF, there has come more findings against 9.1.2.1.  Ensuring that you are producing and delivering product that meets customer requirements and satisfies the customers’ needs should be one of the primary reasons for implementing a QMS, but this has not necessarily historically been the focus for IATF 3^rd party auditors.
10. 6.1.2.3 Contingency plans – and we’ve come to the end of the list, with contingency plans edging out the top 10.  In a world where semi-conductor shortages, material shortages, labor shortages, and Covid-19 related interruptions have thrown the industry into the wildest ride in its history, this should be a surprise to absolutely no one.  SIs related to cyber-security seem to be a reason as well, but let’s face it, no one was ready for 2021.