We have just started to fully implement Q-Pulse and carried out our 1st internal audit.

Raising an internal non-conformance - no problem; however when it comes to recording an observation, there doesn't seem to be an effective way to issue to the actionee record any actions arising from observation. I realise we could make use of the notes section in 'Properties', but that seems to detach the whole process!

Has anyone else had such an issue [or are we being stoopid] or is Gael looking at implementing a future change that will allow better feedback on observations? - something along the lines of the the response window in 'Actions' [CA/PA].

Second query/point - in the findings section there is a dropdown list for "Accepted By", fine if only one section/area is audited, is there a method for multiple acceptance?

Hi Eric,

There is no ability to manage actions against the Observations area of an audit. An alternative suggestion would be to create an observation CAPA source, wizard and template whereby you have a customised workflow specifically for audit observations. You could also use the filter facility in both CAPA and Analysis to filter out these findings when performing your NCR analysis.

On a similar theme as the above, I would recommend creating a customised workflow specifically for positive comments / best practice observed during the audit.

Also, as you say, Accepted By can be assigned to one person only. We'll log this as an enhancement for future consideration.

Eric, For any audits that we have carried out, so far, the observations have not required any actions (if they did, they would be recorded as non-conformances). Within the Audit Summary Report, we have been able to include the observations list. This can then be shown to the auditees. Do agree with the multiple acceptances. KB

Hi Eric - What we've done is list an observation in the Severity drop down list (along with major and minor) so it's still raised as a CAPA and goes to the owner. The owner is then allowed to mull it over and if they decide to take no action, list why in the stages below and get it closed off.

Re Observations - we have integrated this into "Severity Level" dropdown (Level 1,2,3 & Observation), assigning responsible manager as the "Owner". We are internally presenting this as an auditors opinion and reccomendation towards process improvement. As per internal procedures there is no Corrective or Preventive action for this on entry, unless responsible manager decides to address the observation and assign additional stages. This helps to keep it uniform for all audit observations - irrespective of their compliance nature (deviations or reccomendations).

We are planning to link Audit observations to a modified 'improvement ideas' workflow. As observations are not NC's it seams a shame to label them as such

In the same vein if someone raises an initiative (via the CA/PA module) Q-Pulse sends a non compliance reminder to the "responsible person" which is quite unfortunate for all involved in the process. Rather than having the desired effect of a good idea being raised it has been seen by some as being a negative occurence as they were sent a non compliance ... "please be aware of your responsibility ...." etc. 

This has been sent to Gael as an improvement request for a future version.  

Eric,

Have you changed the subject and content in the reminder message? This could be modified to be brought in line with improvement-based terminology.

All the best,

Martin

For our system we created a additional NC template as an observation so we could demonstrate actions and allocate responsibilities even if its an investigation with a decision not to do anything, I personally find it easier to keep track of this way

Our notified body is a bit picky about showing actions on observations and its easier than upsetting them at the begining of an audit.