D
It is YOUR system!
dr madhavan,
My experience is that auditors will always “read” into the standard. For example, your comment about the records kept for management review. The requirement is to keep records. There is no auditable guideline that says what kind of record, and how to maintain them (other than what is in 4.16/4.2.4). If I videotaped the management review, some auditor would undoubtedly state that the records must be in paper form, and because I don’t have a transcript of the tape I’m noncompliant.
Master lists are one of my favorites. Master lists are not required. Even in the old version, it stated “or equivalent…”. Yet many auditors demand that master lists are absolutely required, as are approved vendor lists.
The point is this. If your document control system works for YOU, and if your management review records provide YOU with enough information to know what went on, then tell the auditor to jump in the lake. Never….Never…..Never accept a nonconformance for any requirement that an auditor makes up, provided YOUR system works. Just explain to the auditor that YOUR system works, and the level of detail in the record, or list, or procedure, or whatever, meets YOUR needs. Also let them know you will replace THEM long before you replace YOUR system. They will promptly find some reason to allow it!
It is YOUR system.
I know this sounds harsh, but I ZERO tolerance for incompetence, unless it’s mine!
Dave B (the other Dave)
dr madhavan,
My experience is that auditors will always “read” into the standard. For example, your comment about the records kept for management review. The requirement is to keep records. There is no auditable guideline that says what kind of record, and how to maintain them (other than what is in 4.16/4.2.4). If I videotaped the management review, some auditor would undoubtedly state that the records must be in paper form, and because I don’t have a transcript of the tape I’m noncompliant.
Master lists are one of my favorites. Master lists are not required. Even in the old version, it stated “or equivalent…”. Yet many auditors demand that master lists are absolutely required, as are approved vendor lists.
The point is this. If your document control system works for YOU, and if your management review records provide YOU with enough information to know what went on, then tell the auditor to jump in the lake. Never….Never…..Never accept a nonconformance for any requirement that an auditor makes up, provided YOUR system works. Just explain to the auditor that YOUR system works, and the level of detail in the record, or list, or procedure, or whatever, meets YOUR needs. Also let them know you will replace THEM long before you replace YOUR system. They will promptly find some reason to allow it!
It is YOUR system.
I know this sounds harsh, but I ZERO tolerance for incompetence, unless it’s mine!
Dave B (the other Dave)