So...just got the email about the new revision and I'm reviewing
Is this review performed by the Level 3 or designee (minimum of Level 2 qualified) in the method being reviewed and records retained?
Compliance Assessment Guidance:
The review shall include the ability of the
individual to process hardware in accordance with approved procedures and/or, when allowed, evaluate and disposition hardware in accordance with customer requirements. Documentation of such reviews shall be maintained on file for review.
Retention period shall be in accordance with the supplierís record retention policy.
Level 2 or Level 3 (including outside Level 3ís) are permitted to conduct performance review of Level 3, if so designated in writing by a Level 3 in method.
THe italic, bold part is completely new and I am kind of confused.
Assume I have a (Responsible) Level III (PT/RT) and 2 Level II (one for PT and for RT).
According to the new checklist, am I permitted to have the Lev III conduct perf. rev. on both Lev II and each Lev II conduct perf. rev. on the Lev III (for each method), if the Lev III designates each of the Lev II in writing?
OR...the Lev II shall be designated by an outside (other) Lev III?
Thanks in advance....