A
Dear friends,
I'm very puzzled about the setcion 820.90 of FDA 21CFR QSR820, Do you have a full understading about this section that could share with me?
I have several questions as below:
1: "The evaluation of nonconformance shall include a determination of the need for an investigation and notification of the persons or organizations responsible for the nonconformance. The evaluation and any investigation shall be documented"
Question: for the lot rejected or high reejct rate, we should evaluate and then investigate, however, tf there is only 1-2 PCS rejected products from production line or parts from receiving inspection, shall we evluate and have of the need for an investigation and then keep the evaluate record as the documented? this is impractical, we don't have the evaluation record for these 1-2PCS , how do I understand this section and how to do?
2: (b) Nonconformity review and disposition.Disposition of nonconforming product shall be documented
Question: disposition for Each Nonconformity product or part should be documented? How do I document the 1-2 PCS and other scattered rejects ( such as 1-2 PCS rejects but the whole lot accepted by AQL in receiving inspection?
3: The evaluation of nonconformance shall include a determination of the need for an investigation and notification of the persons or organizations responsible for the nonconformance.
Question: how to understand this sentence? Does it mean we should review the nonconformance first and then decide whether we need to the corrective action as CAPA?
I really apprecite your help and explanation in advance!
Thanks a lot
Andy
I'm very puzzled about the setcion 820.90 of FDA 21CFR QSR820, Do you have a full understading about this section that could share with me?
I have several questions as below:
1: "The evaluation of nonconformance shall include a determination of the need for an investigation and notification of the persons or organizations responsible for the nonconformance. The evaluation and any investigation shall be documented"
Question: for the lot rejected or high reejct rate, we should evaluate and then investigate, however, tf there is only 1-2 PCS rejected products from production line or parts from receiving inspection, shall we evluate and have of the need for an investigation and then keep the evaluate record as the documented? this is impractical, we don't have the evaluation record for these 1-2PCS , how do I understand this section and how to do?
2: (b) Nonconformity review and disposition.Disposition of nonconforming product shall be documented
Question: disposition for Each Nonconformity product or part should be documented? How do I document the 1-2 PCS and other scattered rejects ( such as 1-2 PCS rejects but the whole lot accepted by AQL in receiving inspection?
3: The evaluation of nonconformance shall include a determination of the need for an investigation and notification of the persons or organizations responsible for the nonconformance.
Question: how to understand this sentence? Does it mean we should review the nonconformance first and then decide whether we need to the corrective action as CAPA?
I really apprecite your help and explanation in advance!
Thanks a lot
Andy