Question

MERMED Inc. is a medical device manufacturer.

The company’s headquarters is located in Houston, Texas. It is a global leader in developing, manufacturing, selling and servicing diagnostic imaging and therapeutic medical devices used to diagnose and treat cardiovascular and other diseases. MERMED earned $300 million of revenue in 2015, while employing more than 10,000 people worldwide. One of it’s manufacturing plants is located in Dingle, Co. Kerry, Ireland. Tom Jones is the plant manager at the Dingle facility.

The Dingle site runs 12 hour shifts, 7 days a week. It has 1000 employees. It manufactures a variety of of medical devices (including Class III devices). A number of it's products are sold in the US and European markets. The facility has a Quality Management System in place. Their Quality Management System is in compliance with ISO 13485:2016 and 21 CFR 820. Their facility is frequently audited by Notified Bodies and the FDA.
The site was recently audited by corporate. The corporate auditing team were checking the site's compliance with ISO 13485:2016 and 21 CFR 820. The auditors found a number of potential non-conformances to ISO 13485:2016 and 21 CFR 820.

You must complete 4 tasks (for each of the 5 incidents/questions):

1.   Review each of these potential non-conformances (5 incidents in total)

2.   Determine if they are non-conformances against the requirements of the ISO13485:2016 AND 21 CFR 820.

3.   If they are non-compliances, write down the specific clause numbers in ISO 13485:2016 AND specific section number of 21 CFR 820 which is applicable (write down the main clause/section in each regulation that the non-compliance is against).

4.   Briefly EXPLAIN your decision.

The design file for the medical Device Alpha 04 was reviewed. The company has not analyzed the service log, problem reports, or other quality sources to verify the effectiveness of each design change and documented the results of the company's analysis.

Answer 1

Answer:

Non conformance Issue observed in the plant : The non conformance is that the following processes are not adequately validated as below, which are to be validated as per the requirements of ISO13485 : 2016 AND 21 CFR 820. As per the requirement of this standard, the plant processes and machines validation to be carried out adequately and validation records needs to maintain at the organization level and upon request from auditor, the auditee should show the records machine and process validation to the auditor.

• The passivation process; which is performed using the BEV 2001 (equipment ID 129868) machine is not validated adequately as per observation found during the audit and the sufficient records of validation are not available.
• The cutting processes which are performed by TANGER 100 (equipment ID 870969).Machine is not validated adequately as per observation found during the audit and the sufficient records of validation are not available.

The above stated are the non conformances against the requirements of ISO13485 : 2016 AND 21 CFR 820.

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