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

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

Personally...If the product does not meet the requirements, it should be documented and investigated. Forget the numbers.

Basically you need to evaluate your material specification and the agreement with the supplier. Is the specification good enough? Clear enough? Does actually specify what it is you order and in what agreed quality and AQL??

If the specification is good enough, then you should implement a statistically based incoming inspection based on the agreed quality.

This way you will have data to back up a possible return of raw material. And you will have a sound basis for allowing the raw material into your production if it is found to be conforming.

It is NOT cost effective to allow non-conforming material into production. It is cost effective to have good specs and agreements, and it is cost effective to have a good incoming inspection system and to back up non-conforming rawmaterial with a controlled system to handle these.
:bigwave: