- PQA Certification
Deciding who 2nd and 3rd shift inspectors report to is a challenge our clients face as they begin to scale for increased work. Can inspectors report to their shift supervisor, or must they report to QA who are usually not present during their shift? ISO 9001 and 13485 require that "Top management shall document the interrelation of all personnel who manage, perform and verify work affecting quality and shall ensure the independence and authority necessary to perform these tasks." The requirement to "manage, perform and verify work affecting quality" happens on every shift, but "ensure the independence and authority necessary to perform these tasks” happens through QA oversight of inspection, on all shifts. Essentially you must have two lines of control:
Daily activity management and supervision on the 2nd and 3rd shifts. They manage the employee as a “worker”, juggling schedules and sick days, breaks, etc. They could of course, set priories for inspection to meet schedule and demand, etc. They can direct what to inspect, but not how to inspect it.
Technical control of the job, training on inspection and Quality related tasks, skills, etc., stays with QA. This line of control ensures that containment policies, sampling plans, MRB, etc. are carried out in accordance with the processes under QA’s control. Inspection is considered a “Special Process” and QA must maintain control of all special processes.