Root cause analysis, continuous improvement and integration
Manufacturing quality standards such as ISO view complaints regarding the safety or performance of a product is a strong indicator of whether a company is in full control of its manufacturing process. Customer feedback has become an integral and important part of compliance requirements, and failure to manage it is the leading factor named in non‐compliance citations.
Simply declaring that a broken device has been reworked doesn’t bode well during an audit. Many firms have complaints evolve into non-conformances because they fail to analyze, follow through and get to the root cause. They also get into trouble because there is no tie‐in to a corrective and preventive action or management review – there is no integration.