Page 72 - Biomedical Engineering and Design Handbook Volume 2, Applications

FDA MEDICAL DEVICE REQUIREMENTS 51

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Acceptance activities, including “inspections, test, or other verification activities” must be performed,
under established procedures, throughout the manufacturing cycle. First, of course, is incoming product:
Incoming product shall be inspected, tested, or otherwise verified as conforming to specified require-
ments. Acceptance or rejection shall be documented.
Id. § 820.80(b).

Note that this covers all incoming product: raw material, components, subassemblies, finished
product, packaging, etc. This activity may be delegated to a supplier under contract if you have estab-
lished quality standards, through vendor qualification, contract, and audit.
Work in progress must also be accepted under this subpart. Your procedures must

ensure that in-process product is controlled until the required inspection and tests or other verification
activities have been completed, or necessary approvals are received, and are documented.
Id. § 820.29(c).

Whatever control system you employ on the manufacturing line, whether paper travelers or an
integrated software system, you need to have processes for acceptance at process steps.
This control continues through the final steps to complete a finished device. You need final accep-
tance criteria to ensure that each run, lot, or batch meets specification. Finished devices must be con-
trolled, sometimes called quarantine, until the final acceptance occurs. The finished product may not
be released into distribution until
(1) The activities required in the DMR are completed;
(2) the associated data and documentation is reviewed;
(3) the release is authorized by the signature of a designated individual(s); and
(4) the authorization is dated.
Id. § 820.80(d).

For each of these types of acceptance you need records showing
(1) The acceptance activities performed;
(2) the dates acceptance activities are performed;
(3) the results;
(4) the signature of the individual(s) conducting the acceptance activities; and
(5) where appropriate the equipment used. These records shall be part of the DHR.
Id. § 820.80(e).

The term “signature” is a holdover from the days of paper travelers. On paper records, a signa-
ture can be initials or some other designator. On electronic systems, the signature must comply with
the electronic records rules in 21 C.F.R. Part 11.
All material passing through the process must be marked to show its status:

Each manufacturer shall identify by suitable means the acceptance status of product, to indicate the con-
formance 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.
Id. § 820.86.

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Id. § 820.80(a).