Question

Company Information:

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).

Note:  ISO 13485:2016 and 21 CFR 820 are available in the "Additional Resources" section, under the section heading "Quality Systems Regulations (EU and US)" (contained within Section A Medical Device Regulatory Affairs).

4. Briefly EXPLAIN your decision in 100-170 words.

QUESTION 1

In the warehouse area the inspectors noticed that there were unlabelled boxes lying outside of the caged storage area. They asked Gerry Smyth, the Warehouse Manager, what they were. Gerry said “they are boxes of product that were water damaged and therefore could not be sent to the customer”

Answer 1

Answer 1:

Non conformance Issue observed in the plant : The non conformance is that the unlabelled boxes were lying outside of the caged storage area. The non conformances are as below

• Unlabelling is non-conformance - The boxes need to be labeled or identified with a “tag of suspection” on material boxes.
• Storage at non specified location is non conformance: The boxes needs to be stored at specified location like NC location or segregation location
• Storing of boxes outside of caged storage area is non conformance. Boxes need to be kept in the caged storage area only.
• Timely action not initiated for the suspected material is non conformance – The immediate action to be initiated for the non conformance material once reported in the organization.
• Process non conformance -The process dealing with non conformance in the warehouse is not appropriate.

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