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820.90
Nonconforming product.
(a) Control
of nonconforming product. Each manufacturer shall establish and maintain
procedures to control product that does not conform to specified
requirements. The procedures shall address the identification, documentation,
evaluation, segregation, and disposition of nonconforming product. 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. (b) Nonconformity
review and disposition. (1) Each manufacturer shall establish and
maintain procedures 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 the justification
for use of nonconforming product and the 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 the product, shall be documented in the DHR. Interpretation:
The manufacturer shall establish and maintain
procedures to control product that does not conform to specified
requirements. These established procedures shall include identification,
documentation, evaluation, segregation, and disposition of nonconforming
product. The evaluation of product non-conformance shall include a
determination of the need for an investigation and notification of the
persons or organizations responsible for the nonconformance. This evaluation
and any investigation shall be documented (820.90). The manufacturer shall
establish procedures for identifying the training needs of personnel who
handle nonconforming products in the course of their work. These people
should be trained to recognize product noncomformance and take appropriate
action to control nonconforming products including identifying product as
nonconforming, documenting and evaluating the nonconformance, and segregating
and disposing of nonconforming product. This training should be documented
(820.25). To facilitate detection of failure or defect
trends, internal problem data, including service reports, and complaints
should be arranged in a way that permits correlating present and past data
for a particular product or product line. This can usually be achieved by
organizing files according to product or product lines. Such data may be
maintained in a computer file for quick accessibility and analysis. The manufacturer shall establish and maintain
procedures that define the responsibility for review and the authority for
the disposition of nonconforming product. Nonconformance may occur in-house,
as well as before product is distributed, along with nonconformances of
distributed product. Procedures shall set forth the review and disposition
process. Disposition of nonconforming product shall be documented. This
documentation shall include the justification for any use of nonconforming
product and the signature of individual(s) authorizing this use
[820.90(b)(1)]. The decision to use a nonconforming product is usually done
by a material review board (MRB). MRB boards should operate according to a
written procedure and be comprised of individuals having the knowledge to
determine suitability for use of nonconforming product. Each manufacturer shall establish and maintain
procedures for rework, including retesting and reevaluation of the
nonconforming product after rework, to ensure that the product meets its
current approved specifications. Rework and reevaluation activities,
including the determination of any adverse effects from the product rework,
shall be documented in the DHR [820.90(b)(2)]. |
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Reference: www.FDA.gov The information provided here is for "public consumption" and is open to interpretation. MedicalDeviceSchool.com is not responsible for the content or the accuracy of the information. For all official interpretation and accuracy we ask that you consult the FDA's website directly and that you consult with your legal and regulatory experts on all matters of interpretation. |
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