On the heels of the revision of TS 16949 to IATF 16949 the AIAG (USA) and VDA-QMC (Germany) are collaborating to improve the automotive Core Tools. These Core Tools are the building blocks of an effective quality management system and include Advanced Product Quality Planning & Control Plan (APQP), Production Part Approval Process (PPAP), Failure Mode and Effects Analysis (FMEA), Measurement System Analysis (MSA), and Statistical Process Control (SPC). Their starting point, aimed at improving risk assessment automotive industry wide, is the FMEA manual.
The Automotive Industry Action Group (AIAG) was established in 1982 and the German Industry Automotive Assn. (VDA-QMC) in 1997. Each organization serves as the IATF oversite office in their respective country. Both organizations serve the automotive industry by standardizing publications for the industry and by providing automotive industry training.
Currently suppliers to both North American and German OEMs are required to use different FMEA rating tables for severity, occurrence, and detection. This has created confusion and related frustration for both suppliers and OEMs. The primary goal of the current collaboration is to revise the rating tables to provide a common rating scale for risk accepted by all German and North American OEMs. The secondary goal is to update the manual in areas that need revision to support risk analysis and harmonize the documents overall. This is a great opportunity to combine the strengths from each FMEA manual with improved risk assessment tools that will support the advancing technology of the automotive industry.
The targeted release of the revised FMEA manual is December 2018 followed by OEM release of their customer specific requirements to support the changes. AIAG and VDA-QMC plan further collaboration to continue harmonization and update of all automotive core tools manuals. These tools have proved so useful that they have also been adopted by the aerospace and defense manufacturing sectors. SimpleQuE has been preparing for the changes and developing the training needed for companies to implement the updated FMEA requirements. Let our automotive experts partner with you as you roll out your FMEA upgrades to meet automotive customer demand and take your FMEA risk analysis to a higher level.
About the author: Kim Roan has completed her undergrad in Mechanical Engineering and her Master’s in Psychology with an emphasis in Organizational Leadership. Kim is a simpleQuE consultant with over 20 years automotive industry experience with 11 years working for a German automotive supplier in the USA and experience supplying OEMs in North America, Germany and Asia across the years of her career.
Would you like to know what 3rd party auditors are looking for when auditing how your company complies with quality system standards like ISO 9001:2015?
What are 3rd party auditors looking for? This is the third of a three part series by Jim Lee, President of simpleQuE
Clause 6 of ISO 9001:2015 – Planning for Risk and Change
In parts one and two of this series of articles, Context of the Organization and Leadership were covered. Next is the topic of Planning for Risk, which brings risk-based thinking to the forefront. Once the organization has identified the risks and opportunities in Clause 4, it needs to stipulate how to address these. The planning phase examines who, what, how and when risks must be addressed. It’s a proactive approach that replaces preventative action and hopefully reduces the need for corrective actions later on.
Particular focus is also placed on the objectives of the management system. These should be consistent with the quality policy and be measurable, monitored, communicated and updated when needed. Changes to the QMS should also be planned and consequences understood to assess risk and minimize potential negative impact.
Third party auditors may use the following for evidence of risk based thinking and integration into the quality management system:
- Design reviews
- Competitive analysis, benchmarking, recall analysis, competitive testing
- Process control plan, internally tighter tolerances and controls than customer specs
- Management reviews
- Process and design FMEA (Failure Mode and Effects Analysis)
- Corrective Actions, and replicating actions across similar products and processes
- Metrics related to objective in management review
- Customer scorecards, dissatisfaction, trends and performance
- Operational meeting minutes with action items for higher risks
- Change in leadership or new programs
- Processes to deal with new technology, new materials, new processes, new products, new suppliers, new packaging, moving production, changing equipment
- Program plan describing and monitoring change
- Equipment maintenance plans and programs
- Calibration frequencies
- Internal audit frequencies, and the need to audit some areas more than others
- Contingency plans
- Strategic or business planning, SWOT (Strength, Weaknesses, Opportunity, Threats) analysis, PEST (Political, Economic, Social and Technological) analysis, etc.
- Approval for capital, along with the justification and risks to invest now or delay to later
- Supply chain risk management with supplier performance, financial stability, sole sourcing, geography with lead times and inventory in transit, leverage, long term agreements, etc.
Not that all of the elements listed above will be needed, but organizations may experience potential issues if:
- Risks and opportunities are not identified when there is clear evidence of problems or need for action
- Risk-based thinking is not driven by leadership
- Actions to address risks and opportunities are not taken or not effective
- Risk evaluation is not applied throughout the QMS (supplier selection and evaluation, new product or service, short lead time, capacity constraints, etc.)
- Measurable objectives are not established
- Objectives are not monitored or changed as the context of the organization changes
- Action is not taken when objectives are not met, or trends are going the wrong direction
- The impact of change is not identified or magnitude of change not understood
- Costs/schedule are not included in defining change
Also, read more about Context of the Organization in Part 1 and Leadership in Part 2.
Source: NQA’s Teaming Conference – August 2017
Congratulations to the entire Barrett team for achieving ISO 9001:2015 certification from global registrar NQA!
Headquartered in Murfreesboro, Tennessee, Barrett Firearms Manufacturing is a world leader in large-caliber rifle design and manufacturing. It was founded in 1982 by Ronnie Barrett, who invented the first shoulder-fired .50 caliber rifle. Continue reading “Congratulations to the entire Barrett team!”