4 replies to this topic

[scoot915]

During GMP audit we had a Major non-compliance for "ceiling in bread department is in poor condition"

 

may be overthinking this but my corrective action seems too simple.

 

I wrote:

Ceiling to be repaired as soon as possible.

Where it is not possible to move equipment to different area of faculty, a temporary tarp has been placed above equipment and production area to protect product from possible contamination.

When equipment is not in use, tarp or plastic covering is placed over equipment to protect possible contamination.

Equipment is cleaned before and after production as per SSOP's.

CCP Metal Detection ensures no metal fragments are in product.

 

 

then added:

date ceiling was repaired.

Internal Audits of building interior and daily visual inspections monitor condition of ceilings.

 

Enough?  Not enough?  

 

Any help will be appreciated.

[Charles.C]

Hi scoot,

 

Insufficient data IMO.

 

What was the risk of the "poor ceiling" causing any significant contamination ?

 

This relates directly to the options for corrective action, eg an immediate significant risk should justify ceasing local production.

[scoot915]

Thanks for your reply.

"The ceiling in the bread department (the oldest and original section of the building) is in poor condition, with signs of blistering paint and wood"  Was the auditors entire non-compliance comment.

 

 

Wish I had a picture of the ceiling so my comment does not sound so stupid...

We did not feel there was a high risk the ceiling would cause significant contamination. So we moved what we could and continued production with the tarps as a precaution.

 

Had the same auditor twice, failed us the first time, passed the second 2 months later.

In the failed audit, for the same question " Are ceilings, walls, windows and doors in good repair ...etc" We got a 10 out of 10 and were compliant. 

That added to our opinion it was not a high risk as there was no notable change to the condition of the roof in two months,  but maybe he just not look up that day.  lol

 

Guess I asked my question too late, whats done is done.

If I add that we did not feel there was a high risk of significant contamination would that make the corrective action any better?????

[Charles.C]

Thanks for your reply.

"The ceiling in the bread department (the oldest and original section of the building) is in poor condition, with signs of blistering paint and wood"  Was the auditors entire non-compliance comment.

 

 

Wish I had a picture of the ceiling so my comment does not sound so stupid...

We did not feel there was a high risk the ceiling would cause significant contamination. So we moved what we could and continued production with the tarps as a precaution.

 

Had the same auditor twice, failed us the first time, passed the second 2 months later.

In the failed audit, for the same question " Are ceilings, walls, windows and doors in good repair ...etc" We got a 10 out of 10 and were compliant. 

That added to our opinion it was not a high risk as there was no notable change to the condition of the roof in two months,  but maybe he just not look up that day.  lol

 

Guess I asked my question too late, whats done is done.

If I add that we did not feel there was a high risk of significant contamination would that make the corrective action any better?????

Hi scoot,

 

Still insufficient data for risk assessment.

 

For example - have there been any actual incidents of falling "particles" ? Did the damaged area overlook "open" product ? 

 

The above is is what the auditor should have asked of course.

 

(added)

If the answer is No then yr corrective actions seem reasonable to me. Open product obviously ups the sensitivity.

 

IMEX a typical generic approach to what is presumably a "non-crisis" scenario is to formalise Corrective Actions such as - 

(a) whether an immediate risk of contamination in which case relevant production should be stopped within the suspect area and a buffer zone around it,

(b) any vulnerable product to be removed/segregated and "repairs" to be carried out followed by any appropriate cleaning and sanitation procedures,

(c) the segregated material to be checked by QA before release,

(d) document the incident for insurance purposes if relevant.

 

I daresay the US may have some additional regulatory stipulations which unknown to me as far as the famous "adulteration" is concerned..

[scoot915]

Thanks again for your help.