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820.86
Acceptance status.
Each
manufacturer shall identify by suitable means the acceptance status of
product, to indicate the conformance or nonconformance of product with
acceptance criteria. The identification of acceptance status shall be
maintained throughout manufacturing, packaging, labeling, installation, and
servicing of the product to ensure that only product which has passed the
required acceptance activities is distributed, used, or installed. Interpretation: Written instructions are necessary to assure that components,
manufacturing materials, etc. are properly identified, processed, and stored
when received. Written inspection and test procedures are necessary to
prescribe the:
Before
acceptance, all components should be either physically separated
(quarantined) or clearly identified as not yet accepted. The decision to
separate or tag not-yet-accepted product should be made based on the
characteristics of the device, the potential for mixups, plant conditions,
and manufacturing practices. Although
820.80 requires a written procedure for accepting components, the Quality
System regulation in 820.5 allows discretion in the quality system. Thus a
very small manufacturer, usually 10 or fewer employees, may only need very
brief written acceptance procedures referencing the purchase orders and
receiving tickets. As the size of the operation, the numbers of activities,
and number of people involved increase, the need for comprehensive written
instructions generally increases. Acceptance
Criteria Manufacturers
should have specific acceptance criteria for components. Acceptance criteria
are the attributes of a component that determine its acceptability, such as
appearance, dimension, purity, performance characteristics, etc. Typically,
acceptance criteria are made a part of the inspection/test procedure. For
example, if component specifications or a drawing adequately describe the
attributes needed in order for the component to perform in its intended
manner, these may be used as the acceptance criteria. If components or the
suppliers of the components have a history of good performance, the
components may be accepted for use after a visual check to assure they are
the items intended and that they are not damaged or contaminated. Components,
which need only a visual inspection, may be accepted using the purchase order
data as acceptance criteria. The purchase order and/or receiving ticket
should at a minimum contain the following information:
For a
standard component, the catalog number may be used as a description. QA
personnel should determine whether the use of any "abbreviated"
criteria are adequate during their audit of production rework, history
records, complaint files, and service records. Testing and Inspection of Product The minimum acceptance activity per current practice requires
that all incoming components and other product receive at least a visual
inspection for contamination and/or damage and be identified as the component
specified on the purchase order. A manufacturer accepting the product has the
discretion to determine when and where product should be inspected, sampled,
and tested for conformance to specifications depending upon the risk that
failure of that component may pose. As appropriate, product may be tested
and/or inspected by:
If components
are tested as part of the finished device, the testing should be able to
reveal failed and "out-of-spec" components and not just that the
finished device does not meet specifications. This determination, of course,
may be performed after removing the component from the device. The rejection
shall be documented [820.80(b)]. Manufacturers
who decide not to sample or test specific components should be able to
justify that decision based on such factors as knowledge of the supplier's
previous performance in providing high quality components, the component
performance history, and application of the components in the device.
Manufacturers may rely on component suppliers to conduct testing if the
manufacturer specifies or is knowledgeable about the supplier's quality
system, particularly the inspection and test programs and the supplier has
specifications that properly define the manufacturer's acceptable limits for
the component or material parameters. These specifications may be used to
meet the device master record requirements for component specifications, if
these accurately reflect the parameters, composition, and configuration
required for the component to perform the function for which it was selected.
Supplier specifications are usually adequate for standard components.
However, a manufacturer who relies on supplier specifications usually has no
control over changes in these and, therefore, should assure at an appropriate
point in the manufacturing process that the components received meet the
desired specifications. If components
are tested by the supplier, acceptance of components can be based on
certification and review of test data submitted by the supplier for the
specific components provided. Certification should accompany each lot of components.
When certification is used, the manufacturer should periodically verify the
validity of the certification through an assessment of the supplier. Where
historical data shows that certain components or other product have been
substandard and resulted in a device failing to meet specifications, or where
performance history has not been established, specific steps should be taken
to assure components meet specifications. Typically, this task is
accomplished by sampling and testing each lot of components to assure that
the components meet specifications. Where appropriate, all significant or
high risk components should be sampled and tested. Manufacturers
may test entire assemblies of components rather than individual components.
If, however, testing an assembly cannot assure fitness-for-use of the
components, then components should be tested on an individual or lot basis,
whichever is appropriate. For example, assemblies with an internal feedback
circuit could have a very marginal component. Because of the circuit design,
the condition of the marginal component might not be detected by testing the
entire assembly. Therefore, the feedback loop in the assembly should be
opened during one of the tests, or the individual components should be
tested. When using a
contract laboratory to test production components, the laboratory becomes an
extension of the device manufacturer's quality system. The device
manufacturer is responsible for assuring that the contractor's test and
inspection procedures are acceptable. This assurance maybe obtained by audits
of the laboratory, by the lab staff, and by the finished device manufacturer.
Inspection
and testing will not improve the quality of components or other product;
however, if the inspection and testing is appropriate and performed
adequately, these activities can be used to prevent or significantly reduce
the use of low-quality or defective product. Through feedback into the
overall quality system, data on products will help identify basic causes of
problems and lead to solutions (820.100). If problems are found, actions such
as design changes, tighter acceptance criteria, supplier assessments, or
change of suppliers may be appropriate. Acceptance
and Rejection Records Adequate
records shall be maintained to provide objective evidence that components
were inspected and accepted, or rejected. These records are a part of the
device history record and should be maintained in a format that facilitates
review. The records, however, are not required to be maintained in a single
file with other production history records, and are typically filed in the
receiving or quality control area according to part number or component
nomenclature. Small manufacturers may use purchase orders or packing slips to
record acceptance and rejection if they contain adequate information. The Quality
System regulation specifies in 820.80(b) that a record of component
acceptance and rejection be maintained. Typically, acceptance/rejection
records should contain:
Obsolete,
Deteriorated, and Rejected Components Obsolete,
deteriorated and rejected components shall be identified (820.60, 820.86, and
820.150) as such and be placed in a separate quarantine area or specially
identified area to prevent mixups. If practical, components should be
individually identified as rejects. Where it is not feasible to tag each
rejected component, as in the case of transistors, bolts, bottles, etc.,
containers or packages of rejected lots should be clearly marked and
otherwise appropriately segregated from accepted components. See 820.86 for
clarification. Manufacturers should determine the need for a separate written
procedure for handling these components based on the size of the manufacturer
and complexity of their devices and operations. Disposition of nonconforming
product shall be documented [820.90(b)]. Records for
rejected components should state whether the components were returned,
scraped, reworked, etc. In very small manufacturers, disposition can be
recorded directly onto the purchase order, receiving ticket, or other
associated document. Small-to-medium sized manufacturers generally record
disposition on the form used to receive components. Most large manufacturers
record disposition of rejected components on standard forms such as a
Nonconforming Material Report (NMR). When
components, materials, etc., become obsolete, many manufacturers assign new
identification numbers to the new version of these components etc. The
obsolete items are retained for other uses, such as repair parts, engineering
projects, etc. In these cases, the old and new items should be adequately
segregated and/or identified to prevent inadvertent use of obsolete
components in production. |
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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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