Supply chain management is a crucial part of manufacturing, especially in sensitive aerospace and defense manufacturing environments. Add in pressures from regulators and government, with new revisions to follow, and the process of staying in compliance can seem complicated. Smart manufacturers use SQM as a means to AS9100 compliance, and follow best practices in supplier quality management to help with compliance across all industry and government regulations including AS9100 Rev D.
As you know, supply chain and purchased material has an important place in the overall product-to-market process. In fact, understanding the entire supply chain and its impact is just as important as understanding manufacturing processes themselves, especially now that more than 80 percent of manufactured goods are purchased.
AS9100 Revision D Compliance by September 2018
Companies must be in compliance with AS9100 Revision D by September 2018. Out of the nine new and revised areas of AS9100 Rev D, management of counterfeit parts is significant, and supplier quality becomes more heavily involved in overall compliance. Implementing a Supplier Quality Management (SQM) system that focuses on the purchased product itself will ensure that you are catching any counterfeit parts, and maintaining regulatory compliance. A good SQM system allows you to know everything that’s pertinent about your purchased material, components, hardware, goods, and even sub-tier external providers.
Production Process Verification and SQM
Consider SQM in Production Process Verification (PPV) – what used to be known as FAI. SQM should be embedded into your purchasing process at all stages. Doesn’t it make sense to capture PPV information in your shop floor compliance system?
In SQM, the inspection process should not only manage the ‘who, when, and where’ of the PPV, but it should also evaluate the actual results of inspection. Instead of having to manually address AS9100 Rev D’s product requirements on paper in an ERP system, an SQM can do that automatically. Key characteristics that need to be inspected can come with criteria that provide instantaneous pass/fail results. Further, some SQM systems (including iBASEt’s Solumina) come standard with the new PPV terminology, PPV tracking, and PPV triggers embedded.
How Does SQM Work?
An effective SQM system provides a real-time, reactive, and logic based approach to the inspection process. In essence, the risk-based thinking stipulated by AS9100 Rev D should be built-in as complex manufacturing enterprises move into compliance with the revisions this year. By creating standardized inspection plans, an SQM can determine the risk of the products coming from suppliers. Using a proper SQM process can help tighten or reduce the amount of inspection based on the control plan, enhancing the desired results. With a supplier scorecard and embedded corrective action, your SQM can provide immediate feedback on whether the adjusted processes are effective in meeting the requirements of AS9100 Rev D. This drives improvement across the plant, while reducing undesired effects like audits, and corrective action.
Visit Solumina’s Supplier Quality Management (SQM) page to find out more about how this software add-on can provide a means to AS9100 Rev D compliance.
- SQM as a Means to AS9100 Rev D Compliance - May 1, 2017
- The SQM Advantage - April 17, 2017
- Waiting for an eDHR Mandate? Best-in-Class Medical Device Manufacturers are Already There - March 24, 2016
- 3 Reasons You Might Fail During a Software Implementation and How to Avoid Them - February 11, 2016
- 5 Ways Manufacturing Execution Systems Will Accelerate Quality in Medical Devices in 2016 - December 23, 2015
- Cost of Quality Roadmap for Medical Device - October 29, 2015
- 7 Strategies For Excelling At Supplier Quality Management In Medical Device Manufacturing - September 29, 2015
- Top Five Reasons Why Medical Device Manufacturers Need Manufacturing Operations Management (MOM) - September 11, 2015