Neglect or legitimate deferral? Is excessive workload or lack of resources in a department or a team a valid root cause for a non-conformance?

[cferrer]

Well, the thing is that a support process was not being followed for a while and went undetected. It was uncovered only later during an audit, long after it had caused abandonment of certain activities. It turns out a person had been transfered and no successor was appointed, leaving the process unattended.
However, this department was extremely overloaded and the issue just probably "not important enough" for them, but it is pretty important for the QMS.

 

[John Broomfield]

That would be a failure of the offboarding and onboarding tasks usually found in HR’s recruiting process.

 

[cferrer]

Yes, I think that conclusion makes total sense. Thanks to everyone for pitching in into the brainstorming process.

 

[Melissa]

Just a thought, I was taught you just keep asking why....why....why... (usually a minimum of 5 times and you should get there) I know, sounds crazy but works for me every time!

 

[optomist1]

Just a thought, I was taught you just keep asking why....why....why... (usually a minimum of 5 times and you should get there) I know, sounds crazy but works for me every time!

Yep although typically dull and boring, the 5 Whys is/are effective, and to effectively execute this, a clear statement of the problem is essential, below a suggested structure....hope this helps Optomist1

 

[d_addams]

you may want to look at process design, what is it about the process that lets people cut corners or allows them to pass on a defect. For example in mechanical assembly you can poka-yoke it so it can't be assembled incorrectly? In package sealing if you use a near vertical table the seal cant be applied to the wrong end (the product would fall out if presented incorrectly). Yes you can't prevent all instances of human error, but are there options to make it harder for people to make the errors in the first place.

 

[Orca1]

Excessive workload or lack of resources in a department or a team can contribute to non-conformance in medical device regulations. However, it is the responsibility of the manufacturer to provide adequate resources, including trained personnel, for management, performance of work, and assessment activities to meet regulatory requirements (21 CFR 820.20(b)(2)).

Non-conformity is defined as the nonfulfillment of a specified requirement (21 CFR 820.3(q)). When non-conformities are identified, they must be investigated, and appropriate corrective and preventive actions should be taken (21 CFR 820.100(a)(2)). If a manufacturer's quality system fails to recognize or address non-conformities, it may be considered a major deficiency (FDA QSIT, Guide to Inspections of Quality Systems, Purpose/Importance, 287).

While excessive workload or lack of resources may contribute to non-conformance, it is not considered a valid root cause. Manufacturers are required to provide adequate resources and address non-conformities through appropriate corrective and preventive actions.

 

[d_addams]

Excessive workload or lack of resources in a department or a team can contribute to non-conformance in medical device regulations. However, it is the responsibility of the manufacturer to provide adequate resources, including trained personnel, for management, performance of work, and assessment activities to meet regulatory requirements (21 CFR 820.20(b)(2)).

Non-conformity is defined as the nonfulfillment of a specified requirement (21 CFR 820.3(q)). When non-conformities are identified, they must be investigated, and appropriate corrective and preventive actions should be taken (21 CFR 820.100(a)(2)). If a manufacturer's quality system fails to recognize or address non-conformities, it may be considered a major deficiency (FDA QSIT, Guide to Inspections of Quality Systems, Purpose/Importance, 287).

While excessive workload or lack of resources may contribute to non-conformance, it is not considered a valid root cause. Manufacturers are required to provide adequate resources and address non-conformities through appropriate corrective and preventive actions.

100% agree with you on this. If one would list 'excessive workload' as a contributing cause (or even the root cause) this should show up as an input/action at management review since one of the elements of management review is to ensure that the organization is resourced appropriately. Then its an issue of was this a special cause (we made an announcement and got a flood of queries and we got back logged, but now things are back to normal) or common cause (our sales have doubled every year for the last 4 but we haven't increased resources in <department X> to handle the increase in volume so they are falling behind in executing).