Out-Sourcing Process

Clause 4.1 of "General Requirements" - indicate that should an organization chooses to outsource any process that affects end product conformity, the organization shall exercise conttrol over such processes...........controls of such outsource shall be identified and documented in the FSMS.

Could this mean:
a. Documenting External Process Flow in our FSMS - with support documentation on Hazard Analysis / Control Measures / CL / Validation etc
b. Have documented and scheduled Supplier Audit / 2nd Party Audit - indicating planned audit frequency
c. Other controls as identified

The industry-specific implications of ISO 22K makes the food safety drag net very effective ........ a truly fantastic FS Standard

If I were managing an ISO 22000 system I would rely on auditing, backed up by up to date documents such as copies of suppliers HACCP plan and FSMS manual. In the long term I would require critical suppliers to become ISO 22000 certified or to another relevant third party scheme such as BRC/IFS etc.

Just my two pence worth.

Regards,
Simon

Charles,

From the CB perspective typical outsourced processes I would expect to be identified would be:

Calibration of monitoring equipment
laundering of workwear
transportation of raw materials/goods in
Pest Control
Maintenance of process equipment

More specialist:

Public relations companies (thinking recall/withdrawal)
swab testing/lab work.
IT company (process control equipment, websites etc)

This could be identified as simply as "we have a contract document with suppliers of each of these processes with clearly specified competence and control requirements". Of course you then need the contract.

However many of these "outsourced processes" will already be (o)PrP's and so the controls are already there.

Of course If you require all suppliers to have ISO22000 (accredited certification of course ) then you can probabley rely upon that for the majority of the control.

Simplisticly you need to know what the outsourced processes are first as many of them will already be controlled but often outside the FSMS

As simon says auditing is very important in controlling outsourced processes but of course with ISO22000 you need to validate the controls over outsourced processes that you have to see if they are effective as well



James

If I were managing an ISO 22000 system I would rely on auditing, backed up by up to date documents such as copies of suppliers HACCP plan and FSMS manual.

Verification and validation of processes and process environment are two different issues but both essentially vital and may lead to a serious review of the supply's safety program if elements of compromises are significant enough. However if we are merely relying on evidence of external certification alone or copies of HACCP Plan etc, sometimes, it can be dangerous as there could be what we call certification abuse by suppliers (reason for survellance audit) or the possibility of an external audit done by an inadequately competent auditor (hence the reason for 2nd party audit).....really quite similar to a "Certificate of Analysis" which is in actual fact raised internally and not by an independent party hence it too requires random verification

But generally, for supplier approval program, options are for suppliers to provide "external auditor's report (rather than just the certificate) together with close-out activities" witnessed and system validated by 2nd party audit or perform a supplier audit yourself. On a different chapter, this really reflects the importance of engaging a truly competent auditor rather than just a popular CB.

Dear All,
Most Important outsourced activity which so far not properly controled is Testings- Microbiological and Chemicals(- like Pesticide residuals) etc.which most of organisations do not have capabilities to test in house.
The control to be enforced on these activities should reflect the safety issue of the product being made.
What is your say?
Appaji

Outsourced processes IMO is referred to processes of products (in short OEM or private label production) where the actual production or conversion happens at an external premise. Surely, since it is OEM, we have to consider an entirely different set of process environment (and expect an agreed approach to the process flow itself)....but the CCP or OPRP controls would require to be identified and verified as in this case, off-site. Since this is a common form of sharing or out-sourcing process facilities, I think this is a very important area for further review.

Outsourced services may refer to a wider scope and purpose such as pest control, external carrier, or in this case, "micro and chemical testing". For us, under our ISO 22000, we identify the test methods (which must be accredited to ISO 17025) for the specific test parameters with our approved outsourced external laboratories. All must also pre-identify who their authorized report signatories are including an agreed mode of reporting that must indicate input support towards the intended verification or validation objective.

The importance of scrutinizing outsourced services through appropriate external communications are to ensure that relevant and interested parties along the food chain uphold the responsibility of protecting the end product or provide support to verify or validate the safe food quality per se.

:spoton: