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How to interpret clause 7.1.5 Control of external elements of FSMS?

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seowsee

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Posted 23 November 2018 - 09:36 AM

How to interprete the clause 7.1.5 Control of external elements of FSMS for ISO 22000:2018? What are the documents/records need? how to fulfill this clause? 



jdpaul

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Posted 26 November 2018 - 05:29 AM

What does the clause state? I have not looked at the new version



PowderQM

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Posted 29 November 2018 - 09:24 AM

Hi,

 

I found this nice document online, maybe it could help

 

http://www.progress-...-Excellence.pdf



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ibrahimhashimissa

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Posted 17 January 2019 - 05:23 PM

Still I am confused
Till now I am not able to differentiate between externally developed elements of FSMS & external provided processes ?



Tony-C

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Posted 18 January 2019 - 04:27 AM

Hi Pseowsee,

 

The requirements of the clause are:

 

7.1.5 Externally developed elements of the food safety management system

When an organization establishes, maintains, updates and continually improves its FSMS by using externally developed elements of a FSMS, including PRPs, the hazard analysis and the hazard control plan (see 8.5.4), the organization shall ensure that the provided elements are:

a) developed in conformance with requirements of this document;

b) applicable to the sites, processes and products of the organization;

c) specifically adapted to the processes and products of the organization by the food safety team;

d) implemented, maintained and updated as required by this document;

e) retained as documented information.

 

So, if you use external resources you need to ensure what is provided is compliant with the standard, applicable, adapted, implemented, maintained, updated and retained.

 

This can be done by taking ownership of such resources, and adapting them to suit and integrating them into your FSMS.

 

Such resources may include software, work carried out by consultants or for example IFSQN Implementation Packages.

 

Kind regards,

 

Tony



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ibrahimhashimissa

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Posted 18 January 2019 - 04:16 PM

Thanks a lot Tony,
Appreciate if you would mention some examples for the “externally developed elements” and some other examples for the “ externally provided processes” in the next clause

Many thanks in advance for your usual support



Tony-C

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Posted 19 January 2019 - 06:12 AM

Thanks a lot Tony,
Appreciate if you would mention some examples for the “externally developed elements” and some other examples for the “ externally provided processes” in the next clause

Many thanks in advance for your usual support

 

 

Such resources may include software, work carried out by consultants or for example IFSQN Implementation Packages.

 

Kind regards,

 

Tony

 

Examples of externally provided services include contract cleaning, pest control, contract maintenance, contract laundry etc.

 

Examples of external processes could be parts of the process that are contracted out so say sorting, irradiation, labelling, packing etc.

 

Kind regards,

 

Tony



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hpkeong

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Posted 20 April 2019 - 07:07 AM

7.1.5 is a New requirement in ISO 22000: 2018.

 

As a consultant, my perspective is quite straight forward towards this requirements.

 

It looks new but in fact it is just trying to ensure all related requirements external to ISO 22000 can always be deployed.

 

If you look at the bibliography which is always available at the last few pages of any ISO standards, one can easily find those useful elements.

 

External developed elements can be deployed in establishing, maintaining, updating and continually improve FSMS. For example, in the area of:

  • FSMS [CAC guidelines which are useful for Process Control, such as for Poultry Processing, Nuts,.., FSSC Schemes keeps releasing new guidelines such as Food Defense and Food Fraud] 
  • PRPs [e.g.: ISO/TS 22002-1: PRP and alike for different kind of industrial, as well sa from US, this well-known CFR Part 210 cGMP]
  • Hazard analysis [e.g.: Decision tree from CAC/RCP and even from ISO 22004: 2005 Guidelines]
  • Hazard control plan (see 8.5.4) [e.g. CAC/RCP General Guidelines for Food Hygiene and alike from many standards]

I wish my sharing is worth considered as part of elements to enhance the overall effectiveness of FSMS.

 

Regards.

 



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Vinish Vijayan

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Posted 20 April 2019 - 11:20 AM

Dear Tony, 

 

Can this be interpreted this way, taking an example: Salmonella is a bio hazard identified for Chicken, egg, nuts etc and cooking/frying/roasting is considered as CCP by most of the factories(industry best practice),  for the temperature and holding time - Critical control limits we refer to the FDA/ FAO guidelines due to the constrains for conducting and validating thermal inactivation studies.

This clause 7.1.5 give us an insight on what to do if we are using these guidelines.



ibrahimhashimissa

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Posted 02 September 2019 - 11:06 AM

Please , anybody to clarify this query :

 

Is Pest control  & Lab devices calibration & External surveillance of product testing & Preventive maintenance contracts considered as Externally developed PRP element of the FSMS clause 7.1.5 , or Considered as externally developed services  clause 7.1.6 ?



Tony-C

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Posted 02 September 2019 - 12:09 PM

Please , anybody to clarify this query :

 

Is Pest control  & Lab devices calibration & External surveillance of product testing & Preventive maintenance contracts considered as Externally developed PRP element of the FSMS clause 7.1.5 , or Considered as externally developed services  clause 7.1.6 ?

 

Hi ibrahimhashimissa,

 

Pest control & Lab devices calibration & External surveillance of product testing & Preventive maintenance contracts fall under 7.1.6 Control of externally provided processes, products or services.

 

7.1.5 is Externally developed elements of the Food Safety Management System: When an organization establishes, maintains, updates and continually improves its FSMS by using externally developed elements of a FSMSincluding PRPs, the hazard analysis etc

 

Kind Regards,

 

Tony



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ibrahimhashimissa

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Posted 02 September 2019 - 12:18 PM

Thank you Tony

 

Could you learn me some example on the externally developed elements (Like what practically)



Tony-C

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Posted 02 September 2019 - 12:22 PM

Sure, as per post 5 above: https://www.ifsqn.co...ms/#entry136403

 

Kind regards,

 

Tony



ChipoChab

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Posted 26 November 2019 - 10:53 AM

Hi. 

 

From my understanding, an externally developed element is something that was not developed by the management system but is adopted by the management system as an integral part of the system. An example is the Hazard analysis and hazard control plan. It was not developed by ISO 22000 but is a very important part. There is many referal guides on how to implement these but you should ensure they align to the FSMS. Something like that



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shivampuneri

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Posted 18 January 2020 - 09:54 AM

Hello everyone!
I think externally developed elements means, ready made set of process developed by external agencies in line with std requirements, like developed by consultants, software industry or testing labs such as procedures, software covering FSMS requirements for a particular section or dept or it can be complete testing procedure module etc. 

This is my interpretation. Other experts can throw some light on this.



Mohan P

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Posted 08 March 2020 - 05:22 AM

Externally developed elements could be FSMS or any of the requirements of ISO 22000:2018 that is developed by a consultant (esp. in case of small scale industries where the necessary expertise may not be available).  The standard itself says "including PRPs, the hazard analysis and the hazard control plan...". In case these or any other requirements (elements) of ISO 22000 is developed by an external agency, the requirement of 7.1.5 to be taken care of.  The comments given by Shivampuneri (given above) aptly explains.



JV.Legal.Alliance

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Posted 18 May 2020 - 12:21 AM

ISO 22000:2018 Clause 7.1.5 Externally developed elements of the food safety management system   # Jakkrit Vipatikom

 

Well-known examples of this approach have been developed by the United States Department of Agriculture (USDA) covering meat and poultry establishments (e.g. USDA Generic Model for Poultry Slaughter, 1999).

 

Other examples are modular approach used by New Zealand as has Northern Ireland (FSANI, 2003) , Generic HACCP-based plan for eggs promoted in New Zealand (NZFSA, 2004) and "Safer Food Better Business" system developed by the United Kingdom Food Standards Agency.

 

Generic HACCP-based plans have been generated by governments and other stakeholders to help small site implement HACCP. Generic plans aim to help food operators think through the food safety problems that can occur and how they can be controlled; they enable food businesses to a process and product. The approach is best suited to businesses operating processes that are consistent within the sector, in particular linear processes (e.g. animal slaughter, meat cutting, fruit and vegetable washing and packing)

 

There are many kinds of Generic HACCP-based plans. Some plans identify the appropriate hazards, while others only suggest the possible hazards (requiring site to select

the hazards applicable to their own processes).   Some require the HACCP plan to be developed from the reference documents provided, while others generate the modular documents in such a way that they can actually become the documented HACCP plan (in this respect they often resemble a workbook).

 

In summary, a pre-developed general HACCP plan needs to be further tailored and adapted by the individual food business.

 

# Jakkrit Vipatikom 


Edited by Jakkrit Vipatikom, 18 May 2020 - 12:25 AM.




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