Internal Audits

Background

A small medical device manufacturing company was challenged with maintaining daily Quality System activities, including conducting internal audits. ECI was engaged to support and maintain the gaps in the firm's Quality System; ensuring compliance to US FDA 21 CFR Part 820 and ISO 13485:2016 (E) Standard.

Approach and Solution

A Senior Quality Engineer collaborated with the client to determine the gaps in the internal audit process. Record review of internal audit files revealed the last audit was conducted greater than eighteen months prior. The previous internal audit identified repeat significant findings, as previously cited by US FDA 483 observations and a warning letter.

ECI resources were required to conduct full comprehensive internal audits under the scope of US FDA 21 CFR 820, ISO 13485:2016 (E), per previous FDA observations, and the clients standard operating procedures (SOPs).

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Comprehensive Action

Internal Audit plans were developed for both business units of the firm. Audit plans included the full scope of the firm's Quality System. It was decided the audits would be conducted remotely, using Teams to facilitate staff interviews and present documents. Additionally, the auditor(s) utilized the desk top audit approach to review SOPs via the client's Share Point site.

Audit schedules were developed, department/process contacts notified, and individual department/process Teams meetings scheduled. The audits were conducted over the course of seven days for two businesses; fourteen process systems (seven/business) were audited, twenty-four (twelve/business) staff interviews held, and more than eighty records reviewed. Audits concluded with a total of thirty-five findings (twenty-one/business A and fourteen/business B). Individual finding meetings were scheduled with all process owners to discuss findings prior to the final audit report being issued.

Final internal audit reports were issued for each business and thirteen (nine/business A and four/business B) Corrective and Preventative Action (CAPA) reports were drafted for each audit finding as required by client SOPs.

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Results

Internal Audits were successfully executed for the 2022 calendar year for client. The client was expecting an External Audit early 2023 and was able to demonstrate compliance of having completed internal audits for 2022.

ECI successfully executed two full comprehensive internal audits under the scope of US FDA 21 CFR 820, ISO 13485:2016 (E), previous FDA observations, and the clients standard operating procedures (SOPs).