IATF 16949 QMS in OEM

Elver.Gatieza

Registered
I'm embarking on this thread as I've recently assumed the role of developing and implementing a Quality Management System (QMS) at an OEM facility in USA. The path ahead is laden with numerous questions and challenges. While I boast substantial experience in QMS, particularly with IATF 16949 and ISO 9001, at tier 1 companies in Canada, the OEM landscape presents an entirely different terrain. Truth be told, I'm currently without a clear sense of direction. Therefore, I'm reaching out to seek your opinions and guidance on the approach you would take. In this moment, I realize there may not be a single "right" answer to these complex questions.

A bit about me: Over the past decade, I've immersed myself in the world of QMS, meticulously designing, implementing, and maintaining systems compliant with ISO 9001 and IATF 16949. I've achieved lead auditor status, accumulated a wealth of knowledge in core tools, conducted audits, and even led teams of auditors. I've had the privilege of interfacing with major American automotive companies such as Ford, FCA (Stellantis), and GM. My previous role involved coordinating activities among 30 sister plants in Canada, fostering a culture of mutual assistance and support.

Now, let's delve into the company. It's a fledgling OEM, boasting over 14,000 employees, yet it lacks a structured system, system audits, documentation, and even basic process maps. The organization is subdivided into various shops, a common structure among OEMs, including Body Shop, Paint, General Assembly, and more. Each shop boasts a substantial workforce, with dedicated unit managers and directors. Currently, these managers operate independently, making decisions that lead to a lack of alignment and standardization across the company.

In terms of QMS development, I find myself at the enterprise level, but I'm standing alone in this endeavor. No one else within the organization possesses knowledge of QMS, and there's no support network to lean on. My first question before accepting this role revolved around top management support and their commitment to meeting IATF requirements when the time comes. I received assurances in this regard.

My initial concept for the QMS is intentionally broad, recognizing that complexity will arise:

1. Perform a gap analysis with respect to IATF 16949 requirements.
2. Begin crafting documentation, starting with process maps, followed by the quality policy, KPIs, process owners, and turtle diagrams.
2.1 Collaborate with process owners to develop the necessary processes and subprocesses for the QMS. For instance, establishing calibration and gauge R&R processes within the Quality domain.
2.2 Create all documented processes mandated by the standard, such as Control of Non-Conforming Processes and Corrective Actions. Involve top management as needed, ensure comprehensive training, and disseminate knowledge throughout all levels.
2.3 Establish an internal audit schedule (covering system, manufacturing, products), encompassing special assessments and Layered Process Audits (LPA).
3. Pursue external certification audits.

These points serve as mere examples, as my plan extends into more intricate details. Now, let's tackle some of the questions that have been swirling in my mind:

1. **Defining Process Owners:** How can I designate process owners when each shop has its own manager for each process? For instance, there are roughly ten quality managers and ten maintenance managers, each operating differently. Although I view each shop as akin to a tier 1 plant, the comparison falls short, as tier 1 plants possess dedicated system coordinators and independent QMS systems.

2. **Scope of QMS:** Do OEMs typically implement a single, plant-wide QMS, or is it organized by individual shops? Should mandatory documents be standardized for the entire plant or tailored to each shop? Consider, for instance, the handling of suspect parts (e.g., rework, scrap, use as-is), which may vary between shops like Paint and General Assembly.

3. **Process Mapping and Standardization:** I'm contemplating a process map that includes all shops as core processes in sequence. My aim is to heavily leverage the system and process approach to ensure uniformity among Quality Managers, regardless of their individual shop contexts. However, I anticipate that requirements may diverge in their application for each shop.

4. **IATF 16949 and OEMs:** IATF 16949 was primarily designed for Tier 1 companies, and some customer-related requirements don't seem to fit the OEM model. Yet, I understand that no requirement can be excluded. For instance, if the end customer is an individual purchasing a vehicle, how do we handle calibration of customer-provided instruments or approval for certain documents during APQP stages? This is a puzzle I'm trying to solve.

5. **Internal Audits in a Complex Environment:** When planning internal audits, how do I choose to audit a maintenance process for the Drive Unit shop as opposed to maintenance processes for Plastics or other shops? My usual approach involves risk assessment, volume, and rejection rates, but does this apply in the context of an OEM with multiple shops?

These questions are just the tip of the iceberg. I'm eager to hear your insights and advice as I embark on this challenging journey. Your support and expertise would be immensely valuable as I navigate these uncharted waters.
 

Golfman25

Trusted Information Resource
My opinion. Your doing it backwards?

First, not 100% sure what you classify as OEM, but it doesn't sound automotive -- so why are IATF? Even if you're in the automotive supply chain, why start with IATF as opposed to starting with ISO 9001?

If it was me, I would spend the first several months documenting what they already do. Doing so will identify for you the various processes and the "process owners," etc. Once you have the lay of the land, you can find duplications, divergencies, etc. between departments, and then work to standardize where such would be beneficial. Only then would I pull out the standard and deal with any specific gaps.

Sounds like you have a giant project. Good luck.
 

Jim Wynne

Leader
Admin
You've created a post that's too long by at least half, which will be impossible to answer without creating even longer posts.
 

Quality-Nation

On Holiday
These questions are just the tip of the iceberg. I'm eager to hear your insights and advice as I embark on this challenging journey. Your support and expertise would be immensely valuable as I navigate these uncharted waters.
Yes, they are uncharted waters - for the vast majority - but there are one or two people who have such experiences with the North American OEs and “imports”. I’d offer to suggest that your list is basically sound, however, there’s a LOT of details which are missing including program management of such an undertaking.
 

Quality-Nation

On Holiday
Few OEM plants have implemented IATF to the point of certification. In the 1990’s, Ford, GM and then Chrysler all implemented ISO 9001 - often at only the plant level, with a few corporate functions becoming certified. With the bankruptcies which ensued, all dropped it like a stone, and of course, most of the folks who had a hand in implementation have long since retired.
As far as I can recall, just one site was IATF certified. Unique experience, most likely. Only a few people who were there, sleeves rolled up are still around
 

Mikey324

Quite Involved in Discussions
I guess my question is what will a certificate actually get you? Is the company performing well? Is a fully structured and certified system a necessity to improve, or can process improvements just be made on company level? Working to improve your processes will always make the company better, and an IATF cert alone will not. The cert isn't a requirement to do the work and keep an eye out for ways to get better.
 

Quality-Nation

On Holiday
One of the Chrysler plants saw an improvement in FTC of 42% because they documented their plant processes and controls. Certification didn’t do much except for vehicle homologation in some countries.
 

Johnnymo62

Haste Makes Waste
The Scope, section 1.1 of IATF 16949 clearly states it's for suppliers of parts and the supply chain. See page 9.

IATF in general is in place to serve the OEMs, not to tell OEMs how to run their businesses.

I do believe OEMs should be using a QMS but IATF 16949 is not applicable.
 

Golfman25

Trusted Information Resource
The Scope, section 1.1 of IATF 16949 clearly states it's for suppliers of parts and the supply chain. See page 9.

IATF in general is in place to serve the OEMs, not to tell OEMs how to run their businesses.

I do believe OEMs should be using a QMS but IATF 16949 is not applicable.
Really, why not? Maybe if they practiced what they preach things would improve. :)
 
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