Let S Talk About the Ex S

Let’s Talk about the Ex’s.

Multiple third party standards or codes have sections regarding exemptions, exclusions or exceptions. These various ‘Ex’s’ (exemptions, exclusions or exceptions) often cause significant confusion. HCG offers this explanation.

An exemption, exclusion or exception may apply to elements of a standard orcode. It may also apply to products, processes or areas within a facility. These elements, products, processes or areas are items the supplier does not wish to be included in the audit. To obtain agreement regarding a proposed exemption, the supplier may be required to submit a writtenrequestto the certification body (auditing company). The request should be factual, detailed and based on risk. The supplier should not assume a proposed exemption is accepted until agreed upon with the auditor and certification body. For some audits, these requests must be received prior to the start of an audit. For others, they are reviewed by the auditor at the time of the audit. Within some standards or codes, there are mandatory elements or fundamental clauses that cannot be excluded or exempted. If this is the case, this is declared as part of the standard or code.

How does a supplier obtain agreement on an exemption? For an exemption to an element or item of the code, the supplier should provide detailed reasoning why a stated requirement does not and will not pertain to their operation. For example, a supplier might request to be exempt from requirements pertaining to product realization and development because this is not now nor is it envisioned to be part of a future company process. Perhaps they make one item only, and plan for no changes. A supplier might also request an exemption regarding stock rotation for finished goods because all items are shipped daily upon completion and not stored on site.

For exemptions regarding specific products, processes or areas, the supplier would provide detail regarding what they are requesting to not be part of the audit. Crucial importance to this is the concept of related risk. If an exempted or excluded item (product, process or area) might have an impact on an included item, the aspects of that potential impact are still part of the audit. For example, one floor of a multi-story building might be excluded or exempted from an audit because it is not used for products intended to be certified. If it was discovered that the proposed exempted area has a pest infestation and it creates increased risk to the area under the scope of the audit, a nonconformance could be issued after the auditor provides evidence of the associated risk.

Whichever word is selected (exemption, exclusion, exception) the key to a successful audit is the communication and demonstration of a stable systematic risk management system. HCG assists clients in focusing on the intent of these and other terms in third party or regulatory requirements. We do not recommend extensive time focused on the terms themselves.

The fundamental objective is always “Excellence in food safety management.”