Internal Auditing vs Review, Verification, etc.
Internal Audit
Re-assessment
Annual Review
Verification
Validation
Thanks,
Internal Audits: inspections of your premises, observing employee practices- they can occur weekly, quaterly, monthly. Set frequency.
Annual review- I usually take my whole program and review everything form SOPs to PRPs, HACCP plan. Document if still effective or if new proceudre or form requires revising. Set frequency.
Verification: is ongoing, monitoring records need to be reviewed and signed off.
Validation: is asking if the program, procedures are effective. You can use test it against scientific data, send out product to labs. You can do a mock recal to validate your recall program. Validations have a set frequency. I send out samples to the lab to ensure bacterial counts are below my set guidelines. I observe my employees to validate that follow hygienic practices. My validations are at a set frequency.
- • Validation, (design and execuation)
- • Verification
- • Reassessment
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Internal Audit is a kind of verification method.
http://www.fsis.usda.gov/PDF/HACCP_Systems_Validation_Draft_Guidance_0412.pdf
during an audit you can check validation materials (technical files -main standards-Academic researches -test reports ,scientific data and...)!
according to ISO 22000 PRPs needs verification/OPRP & HACCP need both validation and verification but inorder to verify all control measures together (PRP-OPRP-CCP) the system needs to be verified at least once a year! so anual review is a part of anual verification of FSMS!
lets have an example:
for cooking (CCP)we have to set a time and tempreature to destroy pathogens in this case we will refere to scientific sources(validation/design) and practically we will check it. for example sending the product to the lab( R&D) we call that one as
(Execution ) part of validation.
we will monitor the coocking for time and temp .
during an internal audit we will check all temp logs ,devisions and corrective actions and followup as verification.
a 3rd party audit is like an anual audit for verification the system.(PRP-OPRP-CCP)
Could anyone please explain how the following are interrelated? Or are these completely 5 different levels of review that we have to do?
Internal Audit
Re-assessment
Annual Review
Verification
Validation
Thanks,
Dear HNG it is needed to refer to any national or international standard while fully explaining and understanding the terms as usually any standard has its own interpretation. However, if you only want to understand these without have any standard baseline then IMO the definitions of above terms would be:
Internal Audit: An independent, organized and planned verification activity to verify whether a system or part of a system is working as per specified or expected requirements. For example if you want to conduct internal audit of cooking department then auditor should not be in direct reporting channel of the department to avoid chances of biasness. Internal auditing should be well planned, well communicated and well documented verification activity. Internal audit frequency is generally need to be per-defined and need to be adjusted w.r.t. risk associated with the functions to be audited. That is if a function is at high risk, its audit frequency should be more than that at low risk.
Re-assessment: Generally this term is applicable to any review or re-evaluation activity used when you have to re-evaluate or review an exiting working system or documentation already gone though a prior verification. Re-assessment is needed when system or a document need to be withdrawn or modified. Re-assessment frequency is either per-defined or based on situation.
Annual review: A re-assessment activity with annual frequency.
Verification: A confirmation, preferably documented, that an activity has been performed as specified or expected.
Validation: A confirmation, preferably documented, that an activity would give or is giving results as specified or expected. For example, while you are planning to apply a control measure at a processing step. You need to validate that control measure to confirm that it would actually provide that same level of control as required. Also, while doing verification throughout a defined span of time, you need to re-validate that control measure by doing a third party verification activity. Another example is provision of potable water to production area. Let's suppose you are planning to use water filtration plant with UV system. You first need to validate that your system under consideration would give potable water of recommended specification. For this you may need to have water testing from any accredited external laboratory. Then once you start using the output of the treatment plant, you need to assign monitoring responsibility to some body preferably on daily basis that filtration and treatment plant remain operational before and during production. You also need to verify the monitoring activity or records at some defined frequency to confirm that monitoring is being performed as required.
Regards:
M.Zeeshan
Dear HNG it is needed to refer to any national or international standard while fully explaining and understanding the terms as usually any standard has its own interpretation. However, if you only want to understand these without have any standard baseline then IMO the definitions of above terms would be:
Internal Audit: An independent, organized and planned verification activity to verify whether a system or part of a system is working as per specified or expected requirements. For example if you want to conduct internal audit of cooking department then auditor should not be in direct reporting channel of the department to avoid chances of biasness. Internal auditing should be well planned, well communicated and well documented verification activity. Internal audit frequency is generally need to be per-defined and need to be adjusted w.r.t. risk associated with the functions to be audited. That is if a function is at high risk, its audit frequency should be more than that at low risk.
Re-assessment: Generally this term is applicable to any review or re-evaluation activity used when you have to re-evaluate or review an exiting working system or documentation already gone though a prior verification. Re-assessment is needed when system or a document need to be withdrawn or modified. Re-assessment frequency is either per-defined or based on situation.
Annual review: A re-assessment activity with annual frequency.
Verification: A confirmation, preferably documented, that an activity has been performed as specified or expected.
Validation: A confirmation, preferably documented, that an activity would give or is giving results as specified or expected. For example, while you are planning to apply a control measure at a processing step. You need to validate that control measure to confirm that it would actually provide that same level of control as required. Also, while doing verification throughout a defined span of time, you need to re-validate that control measure by doing a third party verification activity. Another example is provision of potable water to production area. Let's suppose you are planning to use water filtration plant with UV system. You first need to validate that your system under consideration would give potable water of recommended specification. For this you may need to have water testing from any accredited external laboratory. Then once you start using the output of the treatment plant, you need to assign monitoring responsibility to some body preferably on daily basis that filtration and treatment plant remain operational before and during production. You also need to verify the monitoring activity or records at some defined frequency to confirm that monitoring is being performed as required.
Regards:
M.Zeeshan
Thank you very much. Very clear and concise.
Validation: A confirmation, preferably documented, that an activity would give or is giving results as specified or expected.
Perhaps add "used to give". Covers all eventualities. And perhaps replace "preferably" by "necessarily" ?
As implied by Zeeshan, an alternative (and IMO superior), but still equally debatable, answer would be to quote a standard reference, as implied by Zeeshan, eg Codex, NACMCF for HACCP Validation.
A further interesting OP might have been to ask regarding the typical differences between the terms ? Often (horribly) appears in exams as Compare and Contrast, chills to the bone :smile: .
Rgds / Charles.C