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 Re-assessment is needed when system or a document need to be withdrawn or modified.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
.
