June 13, 2019 Industry Forum Blog Deeper inspection and analysis of both the global and UK top nonconformities shows that in actual fact, local challenges are replicated globally as the top three are shared by all territories. United Kingdom Global 1. 8.5.1.1 Control plan 10.2.1 ISO 9001 Nonconformity & corrective action 2. 10.2.1 ISO 9001 Nonconformity & corrective action 10.2.3. Problem solving 3. 10.2.3. Problem solving 8.5.1.1 Control plan Read Industry Forum’s Principle Engineer, Adam Woodward’s blog on the common challenges and how to address them in your organisation: 8.5.1.1 Control plan IATF 16949 2016 requires organisations to: Develop control plans (in accordance in with Annex A) at the system, subsystem, component and/or material level for the relevant manufacturing site and all product supplied. 9.1.1.1 The organization shall verify that the process flow diagram, PFMEA, and control plan are implemented, including adherence to the following: measurement techniques sampling plan acceptance criteria record of actual measurement values and/or test results for the variable data reaction plans and escalation process when acceptance criteria are not met. IATF rules 5th sect 5.8 each on site audit shall include the assessing and evaluating of at least the following: p) the effective implementation of the control plan, FMEA, and associated documents during the audit of manufacturing IATF UK Trend The 3rd party audit process is identifying a number of major issues with the content and implementation of control plans: Links between the PFMEA and control plan and the cascade of special characteristics into the process documentation and process. Process flow, PFMEA and control plan alignment to ensure all process steps are covered and controlled. The control plan does not reflect the process being observed. Changes have been made to the process and are not included in the PFMEA and control plan. Control plans do not always exist for the process being audited. Benefits of Control plans The control plan reduces waste and improves the quality of products during design, manufacture and assembly. Control plans identify process characteristics and the control methods for the sources which cause variation in product characteristics. Control plans focus resources on processes and products related to characteristics that are important to the customer. The proper allocation of resources on major items helps reduce costs without sacrificing quality. As a living document, the control plan identifies and communicates changes in the product / process characteristics, control methods and characteristic measurement. Control plans (more than just paper) The key principle to understand is that the control plan is a live document, so there should be regular scheduled reviews to confirm its effectiveness. Refer to the requirements in IATF 16949:2016 Clause 8.5.1.1. If the nonconformance level is unacceptable, then investigate if nonconformance is related to incorrect/insufficiently robust definition within the control plan. When investigating conformance or auditing a process: Start with the control plan and look at the amount of alignment between its content and the actual process. See IATF 16949:2016 Clause 7.2.3. 10.2.1 Nonconformity & Corrective Actions ISO 9001 2015 states:- When nonconformity occurs, including any arising from complaints the organisation shall: a) react to the nonconformity and, as applicable: Take actions to control and correct it; Deal with the consequences b) evaluate the need for the actions to eliminate the cause(s) of the nonconformity, in order that it does not recur or occur elsewhere. IATF in rule 5th sect 5.11.5 defines in cases where the accepted corrective actions plan for a minor nonconformity is found to be not effectively implemented, a new major nonconformity shall be issued against the corrective action process and the previous minor nonconformity reissued as a major nonconformity. IATF Global Trend The global trend shows that organisations are not taking effective corrective actions on the issues which are identified during the 3rd party audits, and their problem solving processes are not effective in addressing these issues. Therefore, during surveillance audits repeat nonconformities are being identified with the addition of another major nonconformity being recorded around the corrective action process. The Key The key to successful Problem Solving is to find the root cause of the problem and eliminate it. If the root cause is not identified clearly, then it is tempting to resolve the effect or the symptoms instead. Although the problem may be temporarily “fixed”, the root cause will happen again – it is like a dandelion, it will continue to grow until the root is removed. The cycle of repeatedly resolving the effect is known as Fire-Fighting, and can be very costly as it consumes resources (time, materials etc.). We should avoid this wherever possible. Problem Solving Problem solving can be defined as a process to identify root causes. It aims to resolve problems using a structured, team-based approach. Problem solving by nature is a reactive process. When an organisation first approaches the implementation of problem solving it is usually based on the response/reaction to some failing processes. As the organisation improves, the approach to problem solving changes and can now be used to drive improvement rather than just reacting to complaints and concerns. The ultimate goal of effective problem solving is to apply the lessons learnt to predict failures before the failure occurs. We need to consider as an organisation: What is a problem? How to detect problems When to use problem solving? The Solution Industry Forum offers training and support related to Effective Problem Solving and Core Tools implemention including control plans so if you are interested and would like to find out more then please contact us at [email protected]
