There many business processes or customer and regulatory requirements that trigger manufacturers to put an effective audit management strategy in place. Audits can happen anywhere from the shop floor to the warehouse, so proper audit readiness is a must. Efficient audit management provides for successful navigation of manufacturing operations within a highly-regulated environment.
The following challenges can precipitate the need for improved audit management:
Risk-based Paper Processes
Paper-based audit materials are not only time consuming, but error prone. Records must be available at a moment’s notice and archived for review. If these documents are not easily referenceable, the audit process will most certainly prove difficult.
Unnecessary Transcription/Data Entry
Diverse and non-linked systems duplicate the overall metrics effort. Data entry is both labor intensive and subject to inaccuracy. If manufacturing data and quality data are not synced, audits may result in failure.
Inability to Identify Adverse Situations
Poor audit management can result in missed identification of nonconforming material, or products that don’t meet appropriate compliance standards. Inconsistent quality results occur without the necessary oversight that effective audit management can provide. If a company does not have audits under control, loss is incurred with safety and quality at risk.
Lack of Automation
Prepping for an audit can be an arduous task without automation. Scheduling audits can be difficult and operational conflicts can occur. Without a proper checklist, the audit process can be incomplete or result in more work than necessary.
Poor Supplier Management
Every organization that provides manufactured material, whether components, sub-assemblies, or complete systems is subject to audit. The most difficult part of an audit is delivering the genealogy of the associated components and providing specific manufacturer vs. distributor supplier information. If a company does not have visibility into its supply chain, products fail and overall quality will suffer.
Where to start?
An Electronic Quality Management System (EQMS) is key in helping a company build an effective audit management strategy. The system provides the flexibility to manage customer specific audit processes. An EQMS supports internal and external audits and allow auditors to get their job done more efficiently. With an effective audit management strategy in place, companies can examine their audit process and better predict where improvements can be made.
Expected Outcomes of Effective Audit Management Strategy:
Build a Paperless Audit Trail
Important audit records and checklists can all be stored electronically, providing a digitally secure audit trail history. Signatures and approvals can be completed within the EQMS system. All history associated with quality assurance audits as they are accomplished, is recorded along with any corrective action associated with those audits.
Streamline Data and See Results in Real-Time
An EQMS will synch quality and manufacturing data and provide an accurate picture of what is happening across the enterprise. Access to data in real-time allows auditors to monitor data trends and generate reports to share with executives. Communication is greatly improved with the ability to report on audit activities and findings. Mobile access to audit-based information allows for better decision making and instant online recording of audit findings.
Reduce Risk & Improve Compliance
Companies in highly regulated industries are subject to constantly changing regulations. An EQMS can manage these requirements by ensuring compliance with all AS9100D, ISO 9001:2015, FDA, MIL Standard and other regulations. An effective audit management strategy helps automate processes with a configurable workflow. Companies can set up any type of audit necessary with an unlimited library of audit types to address risks in a swift, efficient manner. Consistent audits reduce the occurrence of nonconformances and generate linked corrective actions to improve overall quality.
Automate the Audit Process for Improved Efficiency
An effective audit management process allows companies to map out an audit schedule to avoid operational conflicts and allow enough time for audit preparation. Automated alerts let employees know when to expect an audit. An EQMS will allow users to schedule role-based audits to ensure consistency and standardized procedures across the enterprise. User-defined audit criteria and user configurable audit/survey types ensure audit success.
Create Transparency in the Supply Chain / Simplify Supplier Onboarding
With effective audit management in place, companies can explore provider related costs and data, and hold poor performers accountable. Companies can choose to delegate verification activities to the external provider and provide real-time provider audit status updates. Accurate information on material, ISO, or process review is readily available through simple queries and creates peace of mind. In addition to managing your existing supplier base with ease, supplier onboarding is simplified with the use of supplier checklists available within the EQMS. By streamlining the supplier selection process, approval time and risk are greatly reduced.
An effective audit management strategy will help improve performance, reduce overall risk and improve compliance. Taking a proactive approach to audits will result in significant cost savings and productivity gains. Prepping, scheduling, and reporting of audits can be greatly simplified by implementing an effective Electronic Quality Management System.
Contact TIP Technologies at (262) 544-1211 to schedule a demo and learn how its TIPQA Quality Management Solution can help identify potential pitfalls to survive an audit.