SimpleQuE representatives were recently invited to attend the Eagle Certification Group auditor training, which included the latest information on anticipated changes to ISO/TS 16949:2016, and they are significant! In May, Eagle participated in 4 days of meetings in Italy with all the stakeholders to provide feedback on the final draft TS standard to be released Q4 of this year. Get ready because the changes will greatly impact automotive suppliers and the industry!
Here are some of the significant changes we learned are in the TS final draft, which is still subject to change. But due to this late date, we anticipate many of the revisions are realistically coming, along with some unexpected new requirements.
- A new layout to 10 clauses to include all of ISO 9001:2015. Get a copy of this standard and begin compliance to the ISO changes, as they will be in the new TS standard.
- Harmonization of the Customer Specific Requirements within the TS standard, along with the core tools requirements.
- A new requirement for a documented process on Product Safety. It should include the identification of regulatory and customer requirements affecting safety, along with approvals for changes, customer notifications/reaction plans, special approval of control plans and PFMEA’s, specific training, and flow down of product safety requirements down the supplier chain.
- A new clause on Corporate Responsibility – in light of the problems with the VW emissions scandal and Takata airbags. There needs to be an escalation policy (which includes whistle-blowing) to improve integrity in social and environmental matters.
- A greater emphasis on process effectiveness and efficiency, with the need for management reviews to include process performance review. A rule that went into effect this year for certification bodies is that if processes are not performing effectively and efficiently and corrective actions taken by the company are not effective in a subsequent audit, the certification body is to write a major nonconformance.
- For plant, facility, and equipment design and layouts, a cross functional team is required, along with risk identification and risk mitigation techniques. This includes manufacturing feasibility prior to, and ongoing evaluations after start up, for maintaining process effectiveness and updating of documentation (control plans, job set-ups). This is also a new input to management reviews.
- A new requirement for customer-specific training as it may relate to customer portals and the communication of information to and from the customer (orders, releases, ASN, PPAP, corrective actions, etc.).
- A process must exist for determining and ensuring training needs for employees working with the customers during the quote, project development and production phases. As appropriate, these employees must be trained in APQP, Customer Specific Requirements, FMEA and Control Plans.
- A new focus and attention on embedded software as part of the design and development process (i.e. engine control modules, emission control systems, etc.). It also has its own clause outside of design, which requires a process for software quality assurance and the use of Automotive SPICE (Software Process Improvement and Capability Determination). A SPICE assessment or audit is also required prior to PPAP.
- Supply chain risk for quality and delivery is a new requirement for consideration in supplier selection. This may include financial stability, volume of automotive business, change management process, business continuity planning, and more.
- Total Productive Maintenance is a new clause requiring documented maintenance goals that include at least OEE (Overall Equipment Effectiveness), MTBF (Mean Time Between Failure) and MTTR (Mean Time To Repair). These also are now inputs to Management Reviews. When objectives are not met, there must be a documented action plan to address corrective actions.
- Companies need to identify manufacturing processes and error-proofing devices that can be bypassed. Based on risk and FMEA severity, bypass procedures must be developed, and may require customer approval. Bypasses must be reviewed daily with focused audits, with daily leadership meetings to reduce or eliminate bypass operations. Restart verification is required when no longer bypassing.
- Non-conforming product that is scraped must now be physically rendered unusable prior to disposal.
- There are new flow-down requirements to suppliers and external providers of products and services, which include cascading down the supply chain for regulatory/statutory requirements and special product and process characteristics.
- Gauge calibration clearly includes monitoring and measuring equipment required to ensure effective control of manufacturing processes.
- Internal audit requirements are enhanced with clear annual plans for the QMS, manufacturing process, and product audits. The number of audits and audit days must be specified and planned. A risk based approach needs to be utilized to prioritize the audit program, based on customer issues, performance trends, and criticality of the processes. Software development capability audits are also required.
- A process must exist to ensure internal auditors can demonstrate competence to audit TS, manufacturing processes and products, core tools, relevant Customer Specific Requirements, and more. There are also trainer requirements that must be met. Approved auditors must be documented and competency monitored through conducting of a minimum number of audits per year (as defined by you).
- Management review inputs are expanded by ISO 9001:2015 and the new TS standard, and include new topics of warranty performance, maintenance action plans, etc. Clear action plans must exist when customer requirements are not met.
- Warranty management is a new clause, requiring a process that also includes warranty part analysis and “no trouble found”.
- All customer complaints and field failures (including returned parts) must initiate formal problem solving and corrective action.
- TS will add back the requirement for Preventive Action.
- A documented process for continual improvement is required.
SimpleQuE offers quality management system consulting, internal auditing and training for Automotive, Aerospace and other industry standards. Contact us to learn more about transitioning to ISO/TS16949:2016.