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hitesh_1973

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Posted 10 February 2009 - 05:34 AM

Hy,

This is my first post to the forum,

We are in process of establishing BRC (CPMS) in our company. We are manufacturer of personal and dental care product under Costmetics, Ayurveda and Drugs Licence approved by FDA Dept. - India

We are expecting help \ guidelince from learned group member on the issue of incedent management. Please Guide;

(1) Type of incident which is required to be monitored?
(2) List of incidents to be display at prime location and required to be reported?

Please forward the copy of incidence management, if possible.

Thanks in advance



Simon

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Posted 10 February 2009 - 09:52 PM

Hy,

This is my first post to the forum,

We are in process of establishing BRC (CPMS) in our company. We are manufacturer of personal and dental care product under Costmetics, Ayurveda and Drugs Licence approved by FDA Dept. - India

We are expecting help \ guidelince from learned group member on the issue of incedent management. Please Guide;

(1) Type of incident which is required to be monitored?
(2) List of incidents to be display at prime location and required to be reported?

Please forward the copy of incidence management, if possible.

Thanks in advance

Well this is a very rare occurence. We do not get many questions on the BRC Consumer Products Standard. I do have a copy of the standard somewhere, I will dust it off and revert later.

Regards,
Simon

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hitesh_1973

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Posted 11 February 2009 - 07:11 AM

Dear Mr. Simon,

Thanks for response,

I am sending herewith attached file containing BRC Global Standard Consumer Products Requirements - Product Group 1 - "Point No. 2.13 - Management of Incidents" for your ready ref.

Please refer and guide.

Kind regards,

Hitesh

Attached Files



Simon

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Posted 11 February 2009 - 09:32 PM

Having read paragraph 2.13.1 it is little wonder you need help. It appears the author was feeling rather verbose that day. Here is paragraph 2.13.1 reproduced in all its glory:


“The company shall have effective and documented processes to manage and control incidents that shall ensure that all foreseen potential and actual failures in product safety, legality and quality can be or are being controlled”


Now to me that means something like this:

1. You know your product and how they are used
2. Therefore you should know what legal and customer requirements apply to your product in terms of quality, safety and legality.
3. You should also understand the variables that could cause a product to fail to meet any of the requirements.
4. You should also understand the likelihood and severity of any potential failure
5. You must have control measures in place to prevent these failures. The extent of control measures are based on risk assessment e.g. likelihood of occurrence X severity of occurrence
6. You must communicate to employees the potential failures and what control measures are in place to prevent the failures.
7. You should be proactive in contacting customers and withdrawing product should you detect a failure has escaped to the customer

That’s what it sounds like to me anyhow. I don’t know I’m just trying to be logical. Maybe some risk assessment such as Failure Mode Effects Analysis or similar is required.

Hope this helps. :smile:

Regards,
Simon


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hitesh_1973

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Posted 12 February 2009 - 06:53 AM

Once agains thanks.

We have System for ISO 9001- 2000 and HACCP

There are detailed specfication of R. M, P.M, F.G and same are monitored and controled through Lab. Testing. We have a Glass policy, Drop Policy, Jewellwery Policy, Health and Hygine policy, Gowning Policy, Product recall and withdrawal policy etc. We have PRPs, OPRPs, HACCP Plan, Risk and Severity Chart also.

At present, we are controlling and monitoring all NCR through NCR Report.

In this circumstances, we r little bit confuse, as one of our auditor (Pre- inspection) has raising the question about non fulfillment of the point i.e. 2.13 - Management of Incidents'.

He raised the query and guide that you should have to defined;
(1) the event which is to be constitued the incident,
(2) list out all the potential incident, and
(3)communicate it to relevent employee

in the light of above, please guide what we have to do?

Thansk in advance.

Hitesh


how to meet these particular



Saviour

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Posted 12 February 2009 - 07:56 AM

Hi Hitesh!!

Very well said by Simon.
You need to indentify all potential incedents that may occour and occoured in past related to product safety, legality and quality.
List down all and define corrective and correction actions with identified resposibility with in the management system.
Communicate to all concerns thru trainning and display etc.

Hope this will help you.

Regards
Monika



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Posted 12 February 2009 - 08:02 AM

DEar HItest .. I think in ISO TS 22004 that have a list of incident (emrgency sitations) here is the list :
5.7 Emergency preparedness and response
The organization should be aware of potential emergency situations which may include, for example, fire,
flooding, bioterrorism and sabotage, energy failure, vehicle accidents and contamination of the environment


IMO In ISO 22K system we have to prepare for emergency situation that can efect to product safety..



Simon

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Posted 17 February 2009 - 08:37 PM

Hitesh did you get the information you needed?


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