Internal Audit - Covering all relevant areas - What areas might NOT be relevant?

[Raffy]

Hi everyone,
I had problem with regards to our Internal Audit that was been conducted but failed to cover all relevant areas as defined in the Master Plan. E.g if the scope include the following: Control of Records, Training and Awareness, Management Review, Document Control, Control of Nonconforming Product. What could be the necessary corrective action if we failed to cover all of them? What could be the best corrective action we could make so that we would not experience the problem?

During audit,we failed to make a clear justification on why such areas were not covered during the audit nor there was a plan to complete the audit...
My question do we need to revise our specs according to our needs? How?

Any feedback would be appreciated.
Thanks in advance.
Raffy

[Randy]

During your audit cycle you must audit each element of the standard and your organization. Not all elements will apply of course to every part of your organization.

I would say if you got an NC for not auditing something go and audit it. Review your audit plan, make adjustments, and continue to march. If your review indicates that you still do not need to audit certain things for whatever reason, make sure it is documented. It will be hard to justify not auditing those relevent areas that you identified in your Master Plan though.

[gpainter]

You must follow your audit schedule. If your schedule says audit purchasing once every six months then do it.

[M Greenaway]

Raffy

This is one good reason to use checklists, they ensure coverage of everything you want covered in an audit.

[E Wall]

Raffy, you might also want to consider having someone other than the auditor (we use the plant MR - QA Mgr) review the Audit Report and supporting documentation for closure approval. We are all human and prone to occasional errors which are hard to catch if we've done all the prep and actual work on a project (be it reports, audits, checklists, etc...)

This provides for another pair of experienced eyes to review all information making sure any loops are closed (so to speak) and serves to keep the MR up to date on current status of all audits.

I think the problem basically is not the system on how you would perform auditing, but basically the auditors who won't perform their job., e.g auditing per se...however ,problem like this is that you must set an alarm. One should be looking on your plans and tracj peridoically who were the auditors that who don't perform the job....then if they are not escalate the problem to the higher level for example in your operations meeting where the GM was there to help you solve your problem.

Hope this helps.

Best regards,
Vash

[barb butrym]

Your working papers could have a table for n/c observations in the areas listed as global elements....a 0 would indicate that there were none noted...I personally would rather have examples of good samples listed...but hey, not everyone feels like that...what I do is have a desk review of those tables, then assign action/follow up at subsequent audits based on the results...and call that review a major part of the element audit for the year...do a pareto of all audits for management review. I call it horizontal auditing.

So........if I were doing an audit of doc control i would look at/audit the procedure for change and approval review ECNs(or whatever)...then i would check the tables of the audits (am now using a data base for this) and see what renegade doc issues, distribution, rev issues, etc were noted..saves me from going out into the entire factory on a hunt....the resulting report is the audit for doc control...

Do the same for records, training, n/c stuff, calibration, policy, resourses, communication, id & trace, insp status, ESd, safety, storage etc.... Saves mega time and covers more area.......

did i go off in the wrong direction? i read the original post quickly..if i did ...sorry