Well, I hate to do this, but - what the hell. Entela sent out a news letter and they said:
4.10.4.2 Do "Final Produt Audits" (or "dock audits") have to be included on all control plans?
Interpretation: No. They may be included depending on the particular process for final audits that has been defined by the supplier. A dynamic dock audit program that constantly changes and evolves (sic) based upon PPM's and other company performance measures could not logically be defined on a control plan. Reference may be made to the applicable procedure on the control plan.
4.10.4.2 Can Dock Audits be conducted on the mnufacturing / assembly floow prior to actually closing and sealing the containers? Can the same inspector conduct the final inspection as well as the Dock Audit?
Interpretation: Not typically. The intent of the Dock Audit is to inspect the overall inspection and packaging / labeling process. Therefore, product which has been completed (sealed, labeled and moved) and ready for shipment would enable one to inspect the adequacy of packaging and labeling as well as overall product quality. Since the intent is to inspect the overall process, the same inspector being used for both inspections and final dock audit makes the intent negligable (they would be inspecting their own inspection capabilities). Unique situations may warrant different methods and may be acceptable if deemed effective by the auditor.
**NOTE: I disagree that one person could not do both. I don't buy this 'inspecting their own...' logic. As long as requirements are defined, the same person can check their own work - MY opinion.
OK - the last one (damn - I hate retyping stuff like this...
4.10.4.2 Does every single product characteristic appearing on the control plan have to be inspected accordingly (sic) during a Dock Audit? (i.e., flammability, receiving inspection characteristics of material / components, etc.)?
Interpretation: No. Final inspection instructions and packaging / labeling instructions should (at a minimum) be used for the final audit verification.
OK - Dat's All, Folks! From Entela!
[This message has been edited by Marc Smith (edited 02-27-99).]