Registrar Responses

Slide 88 of 241

Registrar Responses

1. QUESTION: What must be on a Control Plan? -- Every process?

ANSWER: Only the major processes are required on the control plan. Critical processes alone are not sufficient.

2. QUESTION: Does each 'responsibility" have to have *both* Control Plan(s) and FMEA(s)? (e.g.: Receiving has only Control Plans).

ANSWER: Yes, both the Control Plan(s) and FMEA(s) are required.

3. QUESTION: What must be on an FMEA? Every process that is on the Control Plan?

ANSWER: Only the major processes are required on the FMEA. (technology based)

4. QUESTION: White Space - Does every move have to be on the Control Plan &/or FMEA?

ANSWER: Yes, there should be a block on the Control Plan to indicate a transfer.

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