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Hi,
As per 21 CFR part 820: Subpart I - Nonconforming Product,
1. Each manufacturer shall establish and maintain procedure that define the responsibility for review and the authority for the disposition of nonconforming product. The procedures shall set forth the review and disposition process. Disposition of nonconforming product shall be documented. Documentation shall include justification for use of nonconforming product and signature of the individual(s) authorizing the use.
2. Each manufacturer shall establish and maintain procedures for rework, to include retesting and reevaluation of the nonconforming product after rework, to ensure that the product meets its current approved specifications. Rework and reevaluation activities, including a determination of any adverse effect from the rework upon product, shall be documented in the DHR.
________________________________________________
We are class 2 medical device manufacturing company. We would like to refine our current material non-conformance procedure. I have few questions, if someone can help me?
Currently, we initiate material non-conformance for the non-conformities whose disposition is not defined in the procdure. However, there no defined criteria when to initiate material non-conformance. For example, if 5% product found non-conforming or it appears that complete lot may be affected by non-conformity. I will appreciate if someone can answer following questions and provide an example material non-conformance procedure.
How to determine criteria for initiating material non-conformance?
How to determine whether evaluation or investigation of material non-conformance is warranted?
It is not cost effective to investigate each material non-conformance.
Sincerely,
Hitesh Sutaria
As per 21 CFR part 820: Subpart I - Nonconforming Product,
1. Each manufacturer shall establish and maintain procedure that define the responsibility for review and the authority for the disposition of nonconforming product. The procedures shall set forth the review and disposition process. Disposition of nonconforming product shall be documented. Documentation shall include justification for use of nonconforming product and signature of the individual(s) authorizing the use.
2. Each manufacturer shall establish and maintain procedures for rework, to include retesting and reevaluation of the nonconforming product after rework, to ensure that the product meets its current approved specifications. Rework and reevaluation activities, including a determination of any adverse effect from the rework upon product, shall be documented in the DHR.
________________________________________________
We are class 2 medical device manufacturing company. We would like to refine our current material non-conformance procedure. I have few questions, if someone can help me?
Currently, we initiate material non-conformance for the non-conformities whose disposition is not defined in the procdure. However, there no defined criteria when to initiate material non-conformance. For example, if 5% product found non-conforming or it appears that complete lot may be affected by non-conformity. I will appreciate if someone can answer following questions and provide an example material non-conformance procedure.
How to determine criteria for initiating material non-conformance?
How to determine whether evaluation or investigation of material non-conformance is warranted?
It is not cost effective to investigate each material non-conformance.
Sincerely,
Hitesh Sutaria
