Last week, we discussed a video series from IAOB covering the top 10 IATF 16949 major nonconformities addressed by CB auditors in 2021 (you can read that article HERE). Today, we’re continuing this discussion with IAOB’s conversation around the top 10 minor nonconformities issued last year.
It’s always important to take this time to reflect back on nonconformities addressed in previous years to better understand at a high level where organizations struggle to understand QMS requirements or to properly implement them so that we might learn how to better address those weaknesses with the quality systems that we’re working with and better prepare clients to meet requirements. Without further ado, here’s the list of the top 10 IATF 16949 minor nonconformities in 2021.
Since many of these items were also counted in the top 10 major nonconformities, the folks over at IAOB are only commenting on the items that were specific to the minor nonconformities list, starting with the 3rd down:
Total Productive Maintenance
When discussing why they think there are so many findings against this clause, the team looks at the IATF requirements that are very practical and hinge on things like the availability of equipment, spare parts, etc. Equipment condition being maintained, whether it is by the operators, maintenance technicians, or whoever, is key, and 3rd party auditors are apparently finding plenty of instances in which maintenance activities are not adequate or are not being completed, which can obviously lead to unplanned equipment downtime or quality issues, potentially putting customers at risk in the form of missed shipments or of receiving defective products.
The next discussed is the 7th on the list: special characteristics. Almost all customers will have special characteristics defined on prints or other engineering documents, and these characteristics need to be identified and cascaded throughout all of the relevant documentation, such as PFMEA, control plans, standard work, etc. The commenters suggest that there may be so many findings here because organizations simply do not have adequate systems to ensure that special characteristics are properly identified and carried out throughout the remaining documentation, which becomes low-hanging fruit for 3rd party auditors.
Verification of Job-Setups
The next discussed is the next on the list; verification of job-setups comes in at number 8 with 6,966 minor nonconformities written against it by 3rd party auditors in 2021. This is regarding whether an organization has built systems to gain confidence after changepoints and setups in the form of a “first-off” process to ensure that characteristics of the product have been confirmed and there is authorization to resume production after a break in production.
Having so many minors written against this suggests that organizations struggle to establish such systems of verification, or at least to follow the systems that they’ve built and to retain adequate evidence to show that the processes are being followed. Again, not following first-piece verification processes after changepoints or breakdowns is dangerous and will certainly put a customer at risk of receiving defective product. It’s always easier to verify the product quality before starting production than to try to contain defective product after the fact.
Standardized Work – Operator Instructions and Visual Standards
Lastly, we see standardized work coming in the number 9 spot. The commenters believe here that oftentimes work instructions are being developed by engineers who are divorced from the shop floor and the language that the workers would use, creating some instances in which work instructions are being created in a way that might be accurate, but can’t be easily followed because they aren’t understood by operators. This is not to suggest that the engineers must adopt shop-floor jargon to write effective work instructions, but they do need to be cognisant of the audience that they are writing the instructions for and ensure that the documentation that they are creating can be understood by that audience and used as an effective training tool. To not do so is to risk the instructions not being followed, forfeiting process control.
They also feel that there are many cases in which better ways of doing standard work tasks are identified as a process matures, but those new methods aren’t being codified in the work instructions, creating a further discrepancy between the work instructions and the work that is actually being completed. It’s sometimes easy to study and improve a process, looking for opportunities to reduce cycle time and improve OEE, but it’s often a much bigger challenge to come back afterward and ensure that the documentation has been updated to reflect any process changes that have been made, but if you truly want to maintain the process improvements that you’ve made and reap the rewards for the long-haul – and avoid minor nonconformities during audits – you have to make time to keep your process documentation up to date to standardize the improvements.
That’s it; there are the top 10 IATF 16949 minor nonconformities from last year. I always find it enlightening to look at data like this to better understand what portions of a quality standard organizations struggle to understand, implement, or properly control. Many of these findings here resonate as things that I see every day. Does your organization struggle with any of these elements of IATF 16949? Maybe you are included in the data here! Chime in with your thoughts in the comments section and reach out if you need any help better understanding the requirements of IATF 16949!