By: chris howe
Submitted: 2010-05-07 01:07:09 | Word Count: 750
Effectively managing audits is crucial to any quality management program. Good audit management helps to proactively ensure quality by measuring and improving processes, procedures, and marketed services and products. In addition, equipped merchandise and services can be audited to make sure quality adherence throughout the whole value chain. Early detection and prevention through audit activities is the key to lowering product defects, thereby resulting in higher customer satisfaction.
Many of the challenges related to audit management focus on open-ended audits and disjointed business processes. A core basic best practice for audit management is high-down buy-in from the organizational govt management. This level of institutional support ensures that quality is embedded into the fabric of the organization at every level.
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Good audit management programs begin with a transparent definition of audit processes and metrics. In compliance with current regulations, the system should be in a position to trace progress against previous audit deficiencies and identify potential root causes in a very timely manner.
Audits could reveal a variety of issues and process deficiencies. The corrective action method insures that these matters will be identified, tracked, and monitored during a controlled manner. All audit management systems must guarantee compliance with Half 11 and embrace method support technologies like reporting, analysis and trending, regulatory document management and a documented API that supports integration with existing legacy systems like MRP, ERP, electronic records management, and others.
Establishing a totally integrated, closed-loop system like depicted within the figure above can guarantee information flow from one process to another. It ought to be clear that the mixing of compliance processes like those shown higher than can eliminate silos of information and support enterprise compliance management objectives.
Ensure closed-loop processes. For automated audit management systems, ensure that they are designed to successfully shut out all audit processes in a timely manner. As obvious as this sounds, the amount one reason for regulatory citations during this area is because of ineffective process closure.
Avoid "stand-alone" audit management systems. Audit management is an integrated process that needs a mix of several process and compliance technologies to realize real compliance.
Establish proactive internal audit schedule. Continuous improvement demands that organizations periodically review internal policies and procedures and apply the required corrective and preventive actions to ensure quality. One basic preventive action is to perform periodic audits to make sure compliance and operational performance. Corrective action ought to be applied to all method or production problems revealed during audits to ensure sustained compliance.
Automate enforcement of audit checks and balances. Automated systems ought to segregate duties so that the responsibility for the audit is distributed among independent organizations. The system should embrace and support this best practice. Further, the system ought to support a multi-tiered approval method to make sure multiple levels of review and approval. Approvals ought to be documented with twenty one CFR Half eleven-compliant electronic signatures and accessible as documented evidence that audits were meted out with the very best integrity and credibility.
Guarantee on-line and offline access and control. Automated audit management systems must be accessible across the extended enterprise. Most purpose solutions that address audit management are only accessible within the workplace whereas the auditor is online. This can be impractical and promotes process inefficiencies and redundancies. Sensible audit management programs ought to enable offline completion and later synchronization of essential activities.
Leverage integrated document/content management technologies. Audit processes inevitably need documented proof supporting the complete audit event. Throughout the progression of the audit method, auditors could reference controlled documents and generate new documentation in support of the audit. To make sure prepared access to production documentation and the management and management of audit documentation, a sensible audit management system should include integrated document management/content management technologies.
Engineered-in audit alerts and notification. One amongst the key reasons for non-compliance is the shortage of follow-up. Day-to-day challenges and different business issues change priorities in a very dynamic manner. A good automated audit management system should embrace engineered-in alerts to notify management and personnel when pending action is required. These alerts should be including corrective action set up things to confirm follow up and subsequent closure during a timely manner.
