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Deviation Standards in the Food Industry

ddviation nonconformity

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#1 inakarolina

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Posted 23 August 2015 - 07:36 AM

Hi everyone,

I am quite new in the Quality Assurance department of a botanicals production site. I have been given the assignment to prepare Deviation handling procedure.
I would like to know on which standards I can call upon in the procedure?
In the food industry how are the deviations defined and how they are handled?

Looking forward on your comments☺

TNX.


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#2 dv8dawn

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Posted 23 August 2015 - 08:20 AM

Hi, Rolina,

 

If am not mistaken, you are following ISO 22000 and I presume as per FSMS; deviation handling procedure can also called as control of non-conformity procedure. :yeahrite: 

 

Please refer ISO 22000:2005 manual’s clause # 7:10 for the same. The sub clauses are also elaborate, corrections, corrective actions, handling of potentially unsafe products, evaluation for release, disposition of NCP’s and withdrawals respectively. :thumbup: 

 

Cheers,

 

Dv8.


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#3 inakarolina

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Posted 23 August 2015 - 08:27 AM

Thanks Dv8.
Actually at the moment we are not certified in ISO 22000. We have ISO 9001 and HACCP certification.
Regards,
Ina


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#4 dv8dawn

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Posted 23 August 2015 - 08:36 AM

Hi lina,

 

Since HACCP is a part if ISO 22000, you must have a non-conformity control procedure for HACCP certification. However, please refer the link herewith for more clarification:

 

http://www.ifsqn.com...cp-in-catering/

 

All the best,

 

Dv8


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#5 Charles.C

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Posted 23 August 2015 - 11:03 PM

Hi everyone,

I am quite new in the Quality Assurance department of a botanicals production site. I have been given the assignment to prepare Deviation handling procedure.
I would like to know on which standards I can call upon in the procedure?
In the food industry how are the deviations defined and how they are handled?

Looking forward on your comments☺

TNX.

 

Hi Inacarolina,

 

I deduce you are asking about handling deviations in a HACCP Plan?.

 

As per previous posts the specifics would relate to yr product / process of course but the typical approach is via  corrective action and root cause analysis.

 

In case  that doesn't answer yr query, perhaps you could give a little more explanation.


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Kind Regards,

 

Charles.C


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#6 Tony-C

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Posted 24 August 2015 - 05:35 AM

Hi everyone,

I am quite new in the Quality Assurance department of a botanicals production site. I have been given the assignment to prepare Deviation handling procedure.
I would like to know on which standards I can call upon in the procedure?
In the food industry how are the deviations defined and how they are handled?

Looking forward on your comments☺

TNX.

 

Hi Ina,

 

As your ISO 9001 certified, let's look at symetrical requirements:
Clause 7.1 Planning of product realization
In planning product realization, the organization shall determine the following, as appropriate:
a) quality objectives and requirements for the product;
b) the need to establish processes and documents, and to provide resources specific to the product;
c) required verification, validation, monitoring, measurement, inspection and test activities specific to the product and the criteria for product acceptance;
d) records needed to provide evidence that the realization processes and resulting product meet requirements (see 4.2.4).


Clause 8.2.4 Monitoring and measurement of product
The organization shall monitor and measure the characteristics of the product to verify that product requirements have been met. This shall be carried out at appropriate stages of the product realization process in accordance with the planned arrangements (see 7.1). Evidence of conformity with the acceptance criteria shall be maintained.
Records shall indicate the person(s) authorizing release of product for delivery to the customer (see 4.2.4).
The release of product and delivery of service to the customer shall not proceed until the planned arrangements (see 7.1) have been satisfactorily completed, unless otherwise approved by a relevant authority and, where applicable, by the customer.

Products manufactured outside of defined process parameters are handled as per Clause 8.3 Control of nonconforming product

 

For food safety management systems action when there are deviations from critical food safety limits are defined in the HACCP plan. Here is a typical requirement from ISO 22000:
7.6.5 Actions when monitoring results exceed critical limits
Planned corrections and corrective actions to be taken when critical limits are exceeded shall be specified in the HACCP plan.
The actions shall ensure that the cause of nonconformity is identified, that the parameter(s) controlled at the CCP is (are) brought back under control, and that recurrence is prevented (see 7.10.2).
Documented procedures shall be established and maintained for the appropriate handling of potentially unsafe products to ensure that they are not released until they have been evaluated (see 7.10.3).

 

Please note that the best processes have more than one stage of action to a deviation in that first action is taken to bring the process under control before critical limits are breached and the product is potentially non-conforming.

 

Regards,

 

Tony
 


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#7 inakarolina

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Posted 24 August 2015 - 06:16 PM

Thanks all for the extensive elaborations on the topic.

The site has all the procedures required by ISO 9001, but I got confused with the terms deviations and incidents and how they are taken care of in a food safety sistems.

I am off checking the HACCP studies

Regards,
Ina


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#8 Tony-C

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Posted 24 August 2015 - 06:32 PM

Deviation is a confusing term unless defined ... :headhurts:

 

Regards,

 

Tony


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