Full article reprinted from "The Gray Sheet" - December 7, 2009
New guidance from the Global Harmonization Task Force lays out a detailed, four-phase approach to corrective action and preventive action programs within device quality management systems. Read more...
GHTF Releases Long-Awaited Corrective, Preventive Action Guidelines
Full article reprinted from "The Gray Sheet" - December 7, 2009
New guidance from the Global Harmonization Task Force lays out a detailed, four-phase approach to corrective action and preventive action programs within device quality management systems.
The proposed document, dated Sept. 22 and posted online Nov. 25, divides the process of identifying and responding to actual or potential "nonconformities" in a firm's product or processes into four stages - planning, measuring/analysis, improvement and management - with suggested steps to be taken along the way.
For example, in the planning phase, companies should identify all data sources, from adverse event reports to scientific papers, that should be analyzed for potential problems. In the measuring and analysis phase, firms should remember to look across all data sources to determine how serious a nonconformity is, and whether it may be systemic.
A customer survey may signal general dissatisfaction with the performance of a product, the guidance explains, but when reviewed alongside data from complaints or returned product reports, "a significant non-conformity becomes evident."
A key step in the "improvement" phase is determining and ideally validating whether the final corrective and/or preventive actions were effective. If not, the manufacturer should go through the improvement-phase activities again.
GHTF is a voluntary, international group of representatives from device regulatory agencies and industry. Its guidances offer non-binding recommendations for the device industry worldwide.
GHTF says it was careful to avoid using the acronym "CAPA," short for "corrective and preventive action," the language used in FDA's Quality System Regulation (The Gray Sheet' Nov. 30, 2009).
"The concept of corrective active and preventive action has been incorrectly interpreted to assume that a preventive action is required for every corrective action," GHTF states.
The document explains the difference between a correction, a corrective action and a preventive action.
Corrections can be a simple fix, such as stopping a shipment, for problems that pose little risk or are unlikely to recur. Corrective actions, such as retraining personnel, are taken to prevent a problem from recurring, but preventive actions keep potential problems from occurring in the first place, GHTF notes.
Companies should use an escalation process to determine what issues require, for instance, a basic correction versus both corrective and preventive steps. Firms should also have procedures to quickly raise safety or other high-risk issues to company management, the guidance says.
According to one CAPA expert, many firms do not prioritize among corrective or preventive actions very well.
"A lot of companies just throw all CAPA-related issues into one bucket with no priority or even closure dates," former FDA inspector Ken Miles wrote on compliance software maker AssurX's blog Dec. 1. "Prioritize by low, medium and high priority, as well as severity of consequences," he advised.
Medium and serious CAPA issues should be closed out within 30 to 90 days at most, he suggested.
Comments on the GHTF proposal are due in five months.
GHTF Posts Guidelines For Auditing Supplier Audits
GHTF also posted a proposed draft 3 Part 5 of its "Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers" on its Web site Nov. 25.
The Part 5 document, dated Nov. 13, gives guidelines for auditing a manufacturer's purchasing controls, including their policies for when suppliers should be audited and what the audit should cover.
Part 1 contains general requirements. Parts 2, on regulatory auditing strategy, and 4, on multiple-site auditing, were released in September (The Gray Sheet' Oct. 5, 2009).
- Jessica Bylander
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