In our Stage 2 audit we received the following minor nonconformance:
The process to ensure that the internal laboratory scope is defined is not fully effective.
The TS 16949-2009 specification requires that 'The laboratory shall specify and implement, as a minimum, technical requirements for ... competency of laboratory personnel... review of related records.
The Laboratory scope did not capture requirements for competency of personnel or review of related records.
Our laboratory scope document consists of a following matrix that includes:
Test Description | Instrument(s) | Test Method (i.e. ASTM#)
Can I address "competency of laboratory personnel" by linking to our HR Job Description for a Laboratory Technician? It defines the minimum education, experience, skills, and training necessary for the position.
I am at a total loss for how to address "review of related records." Can anyone provide some examples? Many thanks!
The process to ensure that the internal laboratory scope is defined is not fully effective.
The TS 16949-2009 specification requires that 'The laboratory shall specify and implement, as a minimum, technical requirements for ... competency of laboratory personnel... review of related records.
The Laboratory scope did not capture requirements for competency of personnel or review of related records.
Our laboratory scope document consists of a following matrix that includes:
Test Description | Instrument(s) | Test Method (i.e. ASTM#)
Can I address "competency of laboratory personnel" by linking to our HR Job Description for a Laboratory Technician? It defines the minimum education, experience, skills, and training necessary for the position.
I am at a total loss for how to address "review of related records." Can anyone provide some examples? Many thanks!