Implementing QSR and ISO 13485 requirements for CAPA and. We use these definitions, found in ISO 9000. Rework; Process definition; ISO. Iso 13485 Definition Of Rework Process. ISO 13485 is an International. ISO Audit Checklist - Download as Word Doc (.doc), PDF File (.pdf), Text File (.txt) or read online. Definitions in Plain English. In the context of this standard, a manufacturer. It doesn’t matter whether that person actually designs. How can the answer be improved? / Uncategorized / Rework vs Repair. Rework Definition: Correcting of. Vida de los SW Softwares en los dispositivos medicos ISO 62304; ISO to be.

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EXPERT ANSWERS 8D solutions Q: Some of our assembly processes are 100% labor intensive, and in some areas it is difficult to implement mistake proofing. Occasionally, one piece gets rejected at the customer’s end out of, say, 10,000 pieces.

The error is purely nontechnical, such as a missing label or paint mark, visual defect or wrong orientation. We know it is a human error and not a sporadic issue, but some customers insist on exact root cause identification. Is there any specific method to identify root cause in such cases? Ramesh Head of lean and business excellence Bangalore, India A: There are many people who can honestly say they feel your pain; they’ve been there, done that and got the T-shirt. Those people have had similar problems with the production of defects reported directly from the production floor or from the customer via complaints, in which case identifying the root cause may be somewhat difficult. Do these scenarios sound familiar?

There is an important order for a major client. The goods are at the distribution center ready for shipment, when suddenly the production supervisor says, 'Hold the boat—we’ve got a problem!' The call is made to put the goods on hold, and the order is missed. Or maybe a customer received 600,000 parts, and fewer than 10 had broken latches. 'How dare they complain! We got 599,990 parts correct!' In both scenarios, regardless of any indignation the manufacturer may feel, the problem must be addressed.

One way to identify root cause is the Team Oriented Problem Solving (TOPS) technique from Ford Motor Co. Back in the 1980s, when its motto was 'Quality Is Job One,' Ford developed its TOPS methodology. 1 Referred to as the TOPS 8 Discipline (8D), it is a systematic means of arriving at the true root cause. The question you posed is a perfect opportunity to use the TOPS 8D technique. Totally Crackers Fancy Dress Plymouth more.

It is an excellent tool to document problem-solving activities in a manner the customer should accept. The technique has been used to document root-cause and corrective-action activities to the satisfaction of many customers, including General Electric and Intel. TOPS 8D is structured in such a way as to lead a group through a problem-solving activity. The structure is depicted as follows: • D-1: Define concern, organize and plan. • D-2: Describe problem in detail. • D-3: Contain problem. • D-4: Identify and verify root cause.

• D-5: Develop corrective action plan. • D-6: Implement and verify corrective action. • D-7: Prevent recurrence. • D-8: Celebrate and communicate success. When the customer brings an unacceptable part to your attention, the first thing to do if you are using the TOPS 8D is to define the concern or problem in succinct, clear verbiage (D-1). A project plan should be created for the purpose of eliminating the problem and improving the process.

This plan should include scope, key activities, boundaries, responsibilities, timelines and resources. Jimmy Neutron Boy Genius Computer Game here. The resources required for problem solving are best supported by a cross-functional team that best represents the manufacturing process. Next, the team should describe the problem or opportunity for improvement and write a problem statement (D-2) describing the gap that exists between the as-is and desired states. The problem statement must be clear and focused on the specific nonconformance.