Following on from Angela's Community Blog post, tell us what you think...

Have these changes generated lots of work to ensure organisations are complying to the new requirements or has it been a walk in the park?

Hi Daniel,

Thanks for enquiring about the new CPA stds

I suspect it was a little too early to see any feedback on this when you posted in April, but there will now be assessments conducted to the new stds (one of our labs is assessed next week)

I think that the main areas of impact will be:

1. Requirement for evidence of competence assessment. I have posted under another thread in this forum on this and there are lots of QMs, training officers & lab managers worrying about this at the moment. It would be great to have a specific field for competence score associated with a training event as this could remove the need for paper-based systems, so long as it was a field that was easy to pull into reports and was accessible to queries
2. The requirement for assignment of root cause and recording of remedial, corrective and preventive actions to non-compliances would seem almost to have been written by a QPulse user. Existing risk management databases like Datix do not have this.
3. The new CPA H7 std only requires the organisation to have an SOP for the management of non-conformances, but as assessments proceed over the next 2-4 years, I would expect assessors to require evidence that the procedure is being followed and this will be much easier to do if the CAPA module is being used. I am thinking of creating new wizards for EQA & IQC non-compliances because H7 is largely about the actions taken to deal with out-of-control lab tests
4. The new standards have finally included requirements for recording calibration, so the assets module will be of use. Most labs record this elsewhere already, but the ability to schedule periodic calibration, maintenance & validation aloows you to send reminders when these are overdue.