I think some of the confusion in this section is a result of (attempted) rationalisations and expansions from the previous version (which was already messy) + the customary uncertainty over the inter-usage of VER/VAL .
As you just noted, some of the repetition is from sub-clausing. Additionally, it seems logical that where processing steps are related to the product safety, they will have been studied under one’s HACCP requirements already ?
The fact is that the topic of how to interpret and apply “validation” has a substantial history here and elsewhere. As per yr comment, I guess variations are acceptable as long as you make clear yr specific situation and are then consistent. Easy to say but
I think I understand yr ISO9k linkage (not a user myself) but I rather doubt that BRC are trying to narrow the requirements as you hope (?), more likely the opposite IMO, however any BRC auditor around is welcome to correct me.
My evaluation : net result = demand for increased information, such is continuous improvement.
The next version will probably be even worse. *gloom*
Rgds / Charles.C
added – if you are interested to see how various organisations (USFDA, Codex etc) interpret HACCP validation and verification can try this link which compares them in a table, pgs 288-291. the index page (401) also has other applications of their use (successive pages obtained by clicking within the shown page).
added (2) - to illustrate a few applications I extracted the following examples (not all from the food trade) -
(1) 7.2 A cleaning validation protocol should describe the procedure used to validate the cleaning process. It should include in addition to other information: description of the equipment used; interval between the end of production and the beginning of the cleaning procedures; cleaning procedures to be used for each product, each manufacturing system or each piece of equipment; sampling procedures with rationales; analytical methods including limit of detection and limit of quantitation; acceptance criteria with rationales and conditions for re-validation.
(pharmaceutical industry - http://www.hc-sc.gc....ettoyage_e.html )
(2) The processor should have specifications from the pouch supplier for sealing bar temperature, pressure and dwell time necessary to obtain a good seal. Using these specifications, it is important that the processor first validate the heat sealer by running several filled pouches through the sealer, followed by burst testing. During production, monitoring the sealing bar temperature, pressure and dwell-time and carrying out burst testing on a regular basis will demonstrate that the specifications are achieved on a continuous basis.
(food retortable pouch - http://www.inspectio...ac/chap3e.shtml )
(3) The FDA defines process validation as follows:
Process validation is establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality characteristics.
It is important that the manufacturer prepare a written validation protocol which specifies the procedures (and tests) to be conducted and the data to be collected. The purpose for which data are collected must be clear, the data must reflect facts and be collected carefully and accurately. The protocol should specify a sufficient number of replicate process runs to demonstrate reproducibility and provide an accurate measure of variability among successive runs. The test conditions for these runs should encompass upper and lower processing limits and circumstances, including those within standard operating procedures, which pose the greatest chance of process or product failure compared to ideal conditions; such conditions have become widely known as "worst case" conditions. (They are sometimes called "most appropriate challenge" conditions.) Validation documentation should include evidence of the suitability of materials and the performance and reliability of equipment and systems.
(Medical devices - http://www.fda.gov/C...GUIDANCE/pv.htm )
(General article on validation of selected food safety processes particularly via challenge tests)
Edited by Charles.C, 12 May 2007 - 05:49 PM.