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FDA medical device audits CAPA ISO 13485 ISO 13485 matrix ISO 14001 Professional links 1 Professional links 2 About/contact us
Alpha Quality Assurance provides CAPA guidance for new or existing quality systems




Alpha Quality Assurance Associates 111 Nataqua Avenue Pacifica, CA 94044 Phone 650.359.4297 Fax 650.359.6171 kenmiles@alphaqa.biz .

Corrective And Preventive Action (CAPA)

CAPA (Corrective And Preventative Action) systems the No. 1 target of FDA inspections? Why do they account for 50 percent of all warning letters? Because companies overlook the very practices that auditors are trained to target. Inefficient CAPA systems also make ISO certification difficult for manufacturers.

Alpha Quality Assurance (AQA) provides CAPA guidance for and assures compliance with FDA-regulated manufacturers. AQA can evaluate and improve your existing CAPA system, helping you to understand...

What a poor CAPA system looks like and how it triggers citations
What FDA and other regulatory auditors are trained to look for in CAPA
How to thoroughly conduct a problem investigation
Tips and strategies for analyzing the information
Why finding one root cause is not enough and why pre-existing conditions and actions are critical in avoiding citations
How to select the best possible solutions
How to bring your entire team on board for CAPA compliance
How to translate CAPA system improvements into better operations

For medical device companies, CAPA requirements are stipulated in 21 CFR Part 820.100. For pharmaceuticals, they can be found in 21 CFR Part 211. ISO-adherent companies must also comply with CAPA requirements (ISO 9001:2000 Clause 8.5.2 and Clause 8.5.3). Without a well-functioning CAPA system, FDA inspectors will focus on this area of compliance.

Nonconformance identification

AQA consulting helps you identify product or process nonconformance, customer complaints, incidents, discrepancies, out-of-specification and any other quality issue. With email notification and best practice workflows, the system enables you to collaborate with responsible parties to quickly resolve issues. Milestone dates, with escalation triggers, ensure that CAPAs are closed-out on time. You can also communicate rapidly and clearly with suppliers about dispositions affecting them.

Implementing CAPA systems

The AQA investigation process allows you to track preventive actions to their root cause, eliminating problems at their source and preventing recurrence. AQA sets up review verifications to make sure that a corrective or preventive action has been effective. Failure mode monitoring enable you to establish thresholds that will identify when an adverse trend is developing so you can determine if a CAPA has failed to eliminate a recurring problem.

Integration with your business

AQA makes sure that CAPA controls are well integrated with existing systems, ensuring that changes are consistent and harmonized throughout your business. This integration also provides you with real-time visibility into your process so you can identify regulatory threats and areas of needed improvement. With this information you can make timely, informed decisions - and drive continuous improvement throughout your entire operation.

Alpha Quality Assurance 111 Nataqua Ave Pacifica, CA 94044 650.359.4297 info@alphaqa.biz

FDA Medical Device audits CAPA ISO13485 ISO13485 matrix ISO14001 Links1 Links2 About us

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