Lean Culture Now!

Many companies are finding an increased number of non-conformances as they continually modify their audit questions to focus on the high risk processes in their facilities. This increases the opportunity to improve quality, but does not guarantee you progress. To really drive your organization to achieve single digit PPM and eventually Zero Defects your management team must have good problem solving skills. Identifying non-conformances is a great first step to show you what, where, and when your problems are occurring. The next step is to determine immediate corrective action. This is like step 3 of a Global 8-D process: Develop an Interim Containment Action. This action should protect the customer (internal or external) 100% from the effect of the problem. It should be verified, easy to implement, and cost effective. The auditor or area management must also determine if containment actions are required for product made prior to the finding to protect the customer from a quality spill. Many companies do not realize that the containment action (example: reject prior 8 hour of production) needs to be part of the corrective action. Receiving rejections for products that were made a short time prior to when the non-conformance was found is a good sign that your containment activities were not effective. Implementing the immediate corrective action and containment action must be well documented within the requirements in your Quality Management System. This may require writing a deviation to change the process for a period of time in addition to documenting your actions in your LPA tracking system. If a management person is unable to identify a suitable immediate corrective action, the best action may be to shut down the process and contain the product produced prior to the finding. Effective LPA programs require an upper level management person who has profound knowledge in the non-conformance process area to review and approval the corrective action and containment activities within a short period of time. Management may modify the corrective action or containment activities to improve the protection to keep the customer from receiving poor quality products. Validation of the final immediate corrective action and containment activities will be done by your customers. They will notify you if they receive a quality spill.