In this year’s FDA Top 10 list of 483 citations for quality system deficiencies, quality audit procedures (21 CFR 820.22) are ranked at #9. In today’s medical device manufacturing environment which calls for innovation and globally competitive markets, companies are facing upcoming device tax, 510k reforms, and increased operational costs. Having an effective internal audit program is one way to not only manage these challenges but stay ahead of competitors.
From a compliance perspective, benefits gained from vigilant internal audits of quality management systems include:
- Protecting the manufacturer against issues that would be found by regulators - Providing confidence in the effectiveness of management systems - Resulting in a higher percentage of quality products that conform to specifications and consumer needs
Advantages from an operational perspective:
- Highlights opportunities for product or process improvements - Exposes activities that produce waste or are non-value added to the process - Helps companies focus on strategic cost saving plans in streamlining operations
Critical elements for an effective internal audit whether it is satisfying requirements for US FDA cGMP and 21 CFR 820 Quality System Regulations or other international standards such as ISO 13485:2012 are that it be relevant to the product and/or process, comprehensive, and have well-integrated risk-based principles throughout the product’s life cycle. Secondly, comprehensive internal audits should also be prioritized by primarily focusing on those facilities/manufacturing areas targeted most by regulators and that are most impacted by CAPA, Production & Process Controls (P & PC), Design Controls, and Management Controls.
As previously mentioned, a risk-based approach especially when there is limited time and resources ensures greater coverage and consistent, transparent oversight to effective quality system management across global sites. This approach also saves valuable time and effort by prioritizing manufacturing areas or sites with the most observed deficiencies based on compliance history (Ex. 483 observations or open actions from prior audits), experiencing the greatest level of change (Ex. Changes in equipment, resources, processes), or maturity in the organization (Ex. Recent site or production process acquisitions).
Lastly, a company’s internal audit program would significantly improve its compliance standing and product quality if in-depth assessments of post-market information are included on distributed devices such as recalls, MDRs, corrections & removals, significant changes in device specifications or manufacturing specifications, follow-ups on FDA 483 observation(s) & related CAPAs, and previous Establishment Inspection Reports (EIRs). This retrospective information would help the company proactively address existing or potential quality deficiencies way ahead of the inspectors and avoid costly remediation efforts.
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