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.
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.