If your company is in the automotive supply chain and feeling the pressure from customers to implement a compliant or registered quality system, especially automotive QMS software, you are in the right place.
TLM offers a comprehensive suite of tools necessary for establishing an effective automotive quality management system in alignment with IATF 16949 requirements. Our solutions encompass crucial aspects such as FMEA, 8D, integrated Control Plans, PPAP, and other specialized workflows tailored to the automotive industry. These resources are designed to be easily implemented, especially for companies further down in the automotive supply chain. Additionally, our system includes robust functionalities for efficient management of your own suppliers, ensuring a holistic and streamlined approach to automotive QMS.
After October 01, 2017, automotive companies were no longer allowed to audit their automotive QMS base on the old ISO/TS 16949:2009 standard and audits are now conducted against the requirements of IATF 16949: 2016. The primary focus of an IATF 16949 quality management system establishes focus on continual improvement and emphasizes defect prevention and waste reduction in the supply chain.
Specific Automotive QMS Requirements (IATF 16949:2016)
- Advanced Product Quality Planning (APQP)
- Failure Mode and Effects Analysis (FMEA)
- Statistical Process Control (SPC)
- Measurement Systems Analysis (MSA)
- Production Part Approval Process (PPAP)
Advanced Product Quality Planning (APQP)
9.1.1.2 Identification of Statistical Tools (IATF16949) requires that the organization verifies that appropriate statistical tools are included as part of the advanced product quality planning. APQP is essentially the umbrella process and collections of files under which the tools below are included which ultimately provides design and quality control planning.
The Project Module in Total Lean Management (TLM) QMS Software provides a robust tool for organizing all the activities that may be needed for either a PPAP or APQP project.
But in practice, many organizations do not start with APQP, but will base on PPAP directly for planning and for warrant submission. It saves time, there is no redundant work, and all the data and rules for approval are covered under section 8.3.4.4 Product Approval Process. Therefore, there is no need to do both APQP and PPAP for the same project.
Failure Mode and Effects Analysis (FMEA)
FMEA is a risk management methodology that itemizes potential failures by process / function, and through the evaluation of severity, control and detection determines a Risk Priority Number (RPN) that can then be used to prioritize remediation and mitigation efforts.
The FMEA module in Total Lean Management (TLM) QMS Software can be linked to several other modules as part of APQP or PPAP projects.
Statistical Process Control (SPC)
IATF encourages the use of SPC. Section 9.1.1.2 Identification of Statistical Tools requires the organization to identify, during APQP stage, the kind of SPC to be used. Many will regard the XBar/R chart as equivalent to SPC, but this is not true, there are many types of SPC, and XBar/R chart is only one type, and may not be suitable for all cases. The types of SPC methods to be used should be identified in FMEA and other control plans.
The Inspection Module in Total Lean Management (TLM) QMS Software has SPC reports that can help a company monitor the variation of a given process in real time.
Measurement Systems Analysis (MSA)
This collection of experiments and analysis is performed to evaluate a measurement system’s capability, performance and amount of uncertainty regarding the values measured. The types of variation during inspection activities can include the following:
- Personnel – the operators, their skill level, training, etc.
- Process – test method, specification
- Test Equipment – gages, fixtures, etc
- Measured Items – parts or product samples
- Environmental factors – temperature, humidity, etc.
The Equipment Module in Total Lean Management (TLM) QMS Software allows you to both schedule various quality and calibration events, as well as attach MSA or Gage R&R studies.
Production Part Approval Process (PPAP)
A PPAP helps you establish confidence in component suppliers by defining the approval process for new or revised parts. There are 18 elements in a PPAP, but not all of them are required depending on the circumstances. There are typically 5 submission classifications when conducting a PPAP:
- Level 1 – Part Submission Warrant (PSW) only submitted to the customer
- Level 2 – PSW with product samples and limited supporting data
- Level 3 – PSW with product samples and complete supporting data
- Level 4 – PSW and other requirements as defined by the customer
- Level 5 – PSW with product samples and complete supporting data available for review at the supplier’s manufacturing location.
Total Lean Management (TLM) QMS Software provides Design Level controls to help you define vendor approval level policy as it relates to parts, inspection equipment, etc. The 18 PPAP elements themselves can also be managed in TLM QMS Software to help you establish a fully compliant IATF 16949 quality management system.
These 18 elements of the PPAP and their corresponding TLM modules include:
- Design Documentation (Document Management)
- Engineering Change Documentation (Document Management)
- Customer Engineering Approval (Inventory Part Record)
- Design Failure Mode and Effects Analysis (FMEA Module)
- Process Flow Diagram (Document Management)
- Process Failure Mode and Effects Analysis (FMEA Module)
- Control Plan (Inventory Part Record – Control Plans)
- Measurement System Analysis Studies (Attachments to Equipment Record)
- Dimensional Results (Physical parts to be measured)
- Records of Material / Performance Tests (Attachments to Part Record links to Inspection Module)
- Initial Process Studies (Document Management + SPC data from Inspection Module or attached spreadsheets)
- Qualified Laboratory Documentation (Attachments to Vendor Record)
- Appearance Approval Report (Customer Approval in Document Management)
- Sample Production Parts (Physical parts to be sent to customer)
- Master Sample (Physical part)
- Checking Aids (Inventory Part Record – Control Plans)
- Customer Specific Requirements (Customer Approval in Document Management)
- Part Submission Warrant (Document Management)
Adding vendor approvals to the control plan for an automotive quality management system in TLM
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