We just read the following in a recall warning letter to a medical device company: “Failure to implement procedures for finished device acceptance to ensure that each production run, lot, or batch meets acceptable criteria [21 C.F.R. 820.80(d)]. Specifically, your firm does not follow its SOP (b)(4) - Quality Assurance of Final Packaging of Product,” which requires that, before product can be packaged for shipment, the QA clerk must check the package labels against the work order and verify that the label is correct. This SOP further provides that, after verification, the QA clerk must place his/her initials next to the round barcode labels on the work order. Of the 255 device records reviewed during the inspection, all were missing the QA clerk’s initials to document verification of the work order and label before shipment.” Could label verification via machine vision have helped this company? Thanks for your help. @ Ask The Experts

Andrew Zosel
Microscan
Director
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Andrew Zosel (BSME, MBA) has 12 years of well-rounded expertise on precision data acquisition and control solutions through automation applications ranging from basic bar code traceability and lot tracking up to complex machine vision for inspection, identification, gauging, and measurement. As a Director at Microscan, Andrew is currently responsible for product development and marketing and has been responsible for numerous product innovations including miniature imaging systems. Andrew holds several patents for opto-mechanical systems Andrew has experience in the pharmaceutical, life sciences, nuclear power, semiconductor, and general electronics industries.

Inspection Q&A

We just read the following in a recall warning letter to a medical device company: “Failure to implement procedures for finished device acceptance to ensure that each production run, lot, or batch meets acceptable criteria [21 C.F.R. 820.80(d)]. Specifically, your firm does not follow its SOP (b)(4) - Quality Assurance of Final Packaging of Product,” which requires that, before product can be packaged for shipment, the QA clerk must check the package labels against the work order and verify that the label is correct. This SOP further provides that, after verification, the QA clerk must place his/her initials next to the round barcode labels on the work order. Of the 255 device records reviewed during the inspection, all were missing the QA clerk’s initials to document verification of the work order and label before shipment.” Could label verification via machine vision have helped this company? Thanks for your help.

Asked October 8th, 2009

21 C.F.R. § 820.80 is related to receiving, in-process, and finished device acceptance. Section 820.80(d) specifically states:

“Final acceptance activities. Each manufacturer shall establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria. Finished devices shall be held in quarantine or otherwise adequately controlled until released. Finished devices shall not be released for 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. ”

Since the firm’s own SOP also requires that “the QA clerk must check the package labels against the work order and verify that the label is correct” and “after verification, the QA clerk must place his/her initials next to the round barcode labels on the work order,” the company was definitely not following its own SOPs. Label verification using machine vision can, in general, improve the reliability and productivity of manual inspection but would still not satisfy the company’s own SOP or 21 C.F.R. § 820.80 without appropriate signature records on file.

Andrew Zosel

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