The Impact of Manufacturing Errors on Product Defects

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Summary & ConclusionsThe Forward of the Aerospace Standard AS13004 Process Failure Mode and Effects Analysis (PFMEA) and Control Plans defines the industry challenge of designing and producing a safe, dependable, and reliable product in today's global environment. It reads, “To assure customer satisfaction, the aviation, space, and defense industry organizations have to produce and continually improve safe, reliable products that equal or exceed customer and regulatory authority requirements. The globalization of the industry and the resulting diversity of regional/national requirements and expectations have complicated this objective. End-product organizations face the challenge of assuring the quality of and integration of product purchased from suppliers throughout the world and at all levels within the supply chain. Industry suppliers face the challenge of delivering product to multiple customers having varying quality expectations and requirements.” The world is becoming smaller and there are many opportunities for organizations to cross-over into other industries. Most manufacturers have well-defined systems engineering product development processes based on their current industry. However, global customer requirements demand reliability risk analysis, for both product and process designs, in different formats based on different standards. With limited resources and time, organizations must figure out a common process and format that will meet the needs of all customers. The challenge also extends to ensuring suppliers are all meeting the same requirements. There are 6 steps (phases) organizations follow to complete their quality and reliability risk analysis (FMEA or FMECA) of the product and process designs. Organizations will be able to identify a common documentation format that will deliver the required information of any industry standard. Those 6 steps are: 1) Planning; 2) Preparation; 3) Problem Analysis of Product (or Process) Risk; 4) Risk Assessment and Actions; 5) Actions Results, Risk Reassessment (and Control Plans); and 6) Audit, Feedback, and Follow-up Loop. Consistent application of a common process is critical. If an organization falls short in any one area of the process it could affect the overall quality and reliability of their product.FMEA standards have continuously evolved based on changes in industry application and product complexity. Organizations need to evaluate their internal FMEA process to understand if it will support the quality and reliability expectations of both themselves and their customers. Some standards (such as MIL-STD-1629A) have been cancelled for many years and have not had the benefit of updates based on industry knowledge. If your FMEA process does not consider the following process steps there is an increased possibility your product will not meet your internal or customer requirements