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Procedures on Managing Regul.Contact/Sampling & Path.Envir.Monitrg


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#1 YongYM

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Posted 11 December 2013 - 01:28 AM

Dear all:

 

I need help from you all. Can you share with me the procedures on a) managing regulatory contact and regulatory sampling and b) pathogen environmental monitoring? These two aspects are too new to me. :helpplease: 

 

Thank you very much.

 

 

Regards,

Yong



#2 Charles.C

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Posted 11 December 2013 - 11:28 AM

Dear Yong,

 

You may need to be more specific regarding any context for (a).

 

For (b) I assume you mean food contact surfaces rather than the atmospheric environment.

I assume you mean pathogens and not, for example APC counts. Regardless, in practice the former are often combined with the latter.

No particular pathogens ?

 

I enclose 4 documents on environmental monitoring (env4 orig.attached by esquef).

 

.Attached File  env1 - kraft - Environmental Monitoring, 2004.pdf   928.44KB   266 downloads

Attached File  env2 - RTE, GMP, SOP, ENVIRONMENTAL SAMPLING-TESTING,1999.pdf   219.58KB   226 downloads

Attached File  env3 - Guide to Environmental micro.testing, Microgen.pdf   214.23KB   217 downloads

Attached File  env4 - environmental monitoring program, 2013.pdf   3.7MB   278 downloads

 

There are also numerous documents here specifically for individual environmental pathogens, notably Salmonella / L.monocytogenes, eg -

 

http://www.ifsqn.com...indpost&p=55872

 

Rgds / Charles.C

 

PS - I abbreviated yr thread title to try and get it all in. Feel free to adjust again as preferred. :smile:


Kind Regards,

 

Charles.C


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#3 YongYM

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Posted 12 December 2013 - 02:22 AM

Dear Charles:

 

First of all, thank you. Recently we have been audited by a customer and they want us to establish a procedure on how to manage the regulatory bodies when they come to do inspection / audit and what we should do when the regulatory bodies took samples (for analysis).

 

Any simple reference from the forum members is very much appreciated. Thank you again.

 

 

Yong

 



#4 Charles.C

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Posted 12 December 2013 - 05:59 AM

Dear Charles:

 

First of all, thank you. Recently we have been audited by a customer and they want us to establish a procedure on how to manage the regulatory bodies when they come to do inspection / audit and what we should do when the regulatory bodies took samples (for analysis).

 

Any simple reference from the forum members is very much appreciated. Thank you again.

 

 

Yong

 

 

Dear Yong,

 

IMEX, this is a very unusual customer request, in fact unique for me.  Offhand i do not recall seeing any related references. Sounds like your customer may have  confidentiality issues. :smile:

 

Having been both shipment inspector and auditee, "manage" is open to very flexible interpretation.  With respect to ? eg  Never let auditors out of QA's sight, especially the smart ones ? VIP Luncheon ? :smile:

 

Interested to see any other Procedural ideas.

 

Rgds / Charles.C


Kind Regards,

 

Charles.C


#5 jenky

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Posted 16 December 2013 - 02:28 PM

Dear Yong -

 

Our visitor policy also addresses how inspections are handled.  We have included in our policy:

 

  • Who is responsible for escorting inspectors / auditors;
  • That inspectors must present credentials and state purpose of inspection;
  • How samples by inspectors are handled, i.e. we take a split sample for any confirmation or duplicate testing by an independent laboratory;
  • Photographs are permitted with senior managment permission only and duplicate photos are taken by us;
  • Records are limited to only those permitted by regulation and copies of records may only be taken with permission of senior management;
  • Confidential information (e.g. formulas, etc.) may only be viewed with permission of senior management.

Hope this helps.

 

Jennifer



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#6 YongYM

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Posted 17 December 2013 - 07:03 AM

Dear Jennifer:

 

Thank you. I will take note on the applicable points during the preparation of the above documents. Actually, I also plan to incorporate the managing of regulatory contact / inspection and sampling into the company’s Personal Hygiene procedure under the same section of ‘Visitors’. I will also include:

a) the specific personnel to accompany the regulatory inspection/sampling.

b) taking duplicate or triplicate samples for retention and also for external lab test, if necessary.

c) place the particular batch or lot on-hold until we get the satisfactory result.

d) follow product recall procedure if deemed necessary

e) specify the personnel to keep all the related records.

f) etc.

 

 

Regards,

Yong



#7 Charles.C

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Posted 17 December 2013 - 07:56 AM

Dear Yong,

 

Regarding duplicate samples.

It depends on the specific product / measurement parameters but for self-protection from the (later) positive detection of zero-tolerant pathogens  in solid, particulate foods by regulatory personnel, a negative finding on a retained "duplicate"  is often a futile action IMEX. The well-known sampling limitations / typically low level of pathogen contamination tend to over-ride. And probably rightly so assuming the analytical procedure is valid. :smile: (Some locations do permit extensive re-sampling by lot codes to limit the damage but this can involve very substantial costs.)

 

It is also preferable to pre-arrange the removal of critical process operations to amateur photographers IMO. Many companies cleverly use screened, elevated  viewing areas for visitors although this is defeated where in-line sampling is required. :smile:

 

Rgds / Charles.C


Kind Regards,

 

Charles.C


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