8 replies to this topic

[GMO]

Hi All,

 

before I start, I want to say that I agree with the BRC auditor on this point.  I think she was right; that said, we are audited for 80 days a year and no-one else has raised this issue.

 

When we do internal audits for GMP standards, i.e. basic controls, are people wearing PPE correctly, is the area clean and tidy etc. we put this onto a form and score the audit dependent on risk.  We audit areas once a week and the scores are trended.

 

The BRC auditor, again, I can understand why, said we need to do root cause analysis on any point which could be a food safety, legality or quality issue (i.e. everything) and a corrective and preventive action. 

 

The problem is to do this every week would be prohibitive. So we are going to have to move our GMP auditing to monthly.  Fine, I'm down with a monthly but more in depth audit but...

 

Currently I would say my company is not "mature" in its approach to technical standards.  We're working on culture but a certain level of "policing" is sadly still required.  My question is how I can still ensure my QA team are doing some policing; or even better, some proper value added coaching with the team on weeks they are not required to audit rather than waiting for a month?  Sure I can tell them but how do I know it's happening?  Bear in mind if I get them to record anything, it then needs massive amounts of paperwork to back it up.  I think the point raised was valid; it might actually help us and moving from a "don't do that" culture to guiding and coaching?  All good but how do I make sure it's happening? 

 

Hmm...

 

Any top tips people have had / experienced?  Is this a surprise to any of you that this level of auditing would need RCA?

 

Thanks guys.

[BrummyJim]

It depends on how omnipresent your QAs are. The places I've worked have usually had at least one QA on the floor at all times, keeping an eye out for misdemeanors, checking the lines are running safely, running metal detector tests etc. However, I appreciate that they can't be everywhere, but they should be managing GMP/GHP at all times. Just because they aren't auditing doesn't mean that they're not watching.

[mgourley]

I disagree with the auditor.

There is absolutely no reason to do RCA and CAPA for "every" item on your GMP inspection.

If it's something that would be classified as a "major" or critical" on a BRC audit, then yes, I can see the need.

 

As you stated, it's simply not possible unless you have a department devoted to that sort of stuff.

 

The only place the Standard specifically requires RCA is in section 3.10.

 

Marshall

[Charles.C]

Hi GMO,

 

Did the BRC auditor explain/validate in any way why they believed a 100% application of RCA would be so beneficial.?

 

The philosophy  sounds similar to the early implementations of HACCP where almost every potential hazard seemed to be a Critical one. Then came prioritization.

 

Offhand, and in the absence of contrary specifics, i agree with previous opinions.

[mgourley]

GMP audit finding: "Employee was found to not have all scalp hair covered by hair restraint"

RCA: Due to normal movement, hair restraint moved, exposing scalp hair.

CAPA: Ensure employees glue hair restraints to noggin to prevent movement during regular movement.

 

Risk to product: virtually nil

Time wasted conducting and documenting RCA and CAPA: Too much

Feasibility of implementing and monitoring CAPA: Zero

 

Marshall

[Tony-C]

Hi GMO,

I would refine your procedure such that the RCA only relates to significant (major/critical) issues identified, others should be dealt with as you are doing:
3.4.4 Interpretation Documented inspections
It is important that issues identified at the inspections are corrected as soon as possible and always such that product risk is minimised. The records of inspections and corrective actions must be retained.

Weekly auditing may be excessive, with the spare time created I would do some mentoring with the team, taking them around the facility identifying issues and defining the standards expected. I would do the same with supervisors in their departments as it sounds like their support is needed to help you create the right culture.

By the way RCA is mentioned in other clauses, not just 3.10:

1.1.10 The site’s senior management shall ensure that the root causes of non-conformities identified at the previous audit against the Standard have been effectively addressed to prevent recurrence.
Interpretation Recurring non-conformities
This should be achieved by the accurate identification of the cause(s) of the non-conformity (the root cause) and the introduction of effective preventive action.

3.7 CORRECTIVE AND PREVENTIVE ACTIONS
3.7.2 Where a non-conformity places the safety, legality or quality of products at risk this shall be investigated and recorded including:
• identification of the root cause of the non-conformity and implementation of any necessary actions to prevent recurrence.
Guidance Root cause analysis
An important part of an effective corrective action process is the identification of the root cause or underlying cause of the non-conformity and the implementation of suitable action to prevent recurrence of the non-conformity.

 

Kind regards,

 

Tony

[GMO]

She explained that every non conformity found (whether at audit or not) should have RCA and CA/PA and any item on a GMP audit affecting quality, legality or food safety should have CA/PA but my problem is on my GMP audit all of the issues are related to quality, legality or food safety (except for the positive things found).  Even minor issues have some implications.  At first I thought the same "we'll just do this for high scoring issues" but I looked at our audits and realised that actually really you'd want to do RCA and CA/PA on everything it's just having the bloody time to do it.

 

So in some ways I don't disagree with her, in others, I just don't see how it can work.  I do like this though:

 

GMP audit finding: "Employee was found to not have all scalp hair covered by hair restraint"

RCA: Due to normal movement, hair restraint moved, exposing scalp hair.

CAPA: Ensure employees glue hair restraints to noggin to prevent movement during regular movement.

 

Nice one MGourley

 

I did once suggest to someone who lost a glasses lens in production and didn't notice for hours; "shall I implement a two finger check of your glasses each morning?"
Looks blank
"Shall I move two fingers, one towards each eye while you have your glasses on and see if you say 'ow'?"

 

 

I agree TonyC; believe it or not GMP auditing was daily when I started!

 

Weekly auditing may be excessive, with the spare time created I would do some mentoring with the team, taking them around the facility identifying issues and defining the standards expected. I would do the same with supervisors in their departments as it sounds like their support is needed to help you create the right culture.

 

I already insist the GMP audits are conducted with a supervisor.  Fortunately they're not doing metal detection checks or temperature checks.  There's just only one of me to go around though and only 5 of them with two factories.  It's a lot to keep track of.

 

Anyway, if nothing else I've flagged it up to you guys that this may be something the ridiculously picky BRC auditor in your factory starts to look at. 

[KTD]

Hi GMO  -

 

In our CAPA procedure, we included a matrix (severity * freq/probablity = risk). If the risk does rise above X, we stop there. We trained internal auditors to assign severity & frequency (freq based on findings during the audit & known history). Added columns to the GMP forms to note these values & the resultant risk, so a quick review of the completed audit shows those incidents needing further investigation. Have not had issues with any 3rd party audit.

 

KTD

[GMO]

Hi GMO  -

 

In our CAPA procedure, we included a matrix (severity * freq/probablity = risk). If the risk does rise above X, we stop there. We trained internal auditors to assign severity & frequency (freq based on findings during the audit & known history). Added columns to the GMP forms to note these values & the resultant risk, so a quick review of the completed audit shows those incidents needing further investigation. Have not had issues with any 3rd party audit.

 

KTD

 

I like it.  I will put it to the team.  Thank you.