Non-conformance management is not important just because it is required by your audit company, but because it helps improve business processes and aim at organisational growth. Non-conformances negatively affect businesses reputation, cost, efficiency, and effectiveness. Organisations that struggle to manage non-conformances demonstrate that they are not adept at managing risk, and taking action where issues have been identified..
Here we have what you need to know about non-conformance audit system and how to ensure they don’t fall through the cracks during and after the audit is over. Keep reading.
What is an audit non-conformance?
Non-conformances occur when a service, product, or process fails to meet one or more defined specifications, industry regulation, supplier requirements, or standards. They can be identified at any level of an organisation’s operations such as quality control, management commitment, manufacturing, personnel, procedures, etc.
Non-conformances can be identified by internal and external audits, customer complaints, material inspection or routine testing. They must be managed and corrected as soon as possible bu undertaking corrective and preventive actions (CAPA). Non-conformances that remain open or have not been satisfactorily addressed can lead to reputational and real process risks that can lead to aloss of confidence in the organisation, loss of certification status, or even loss of contracts and business. Organisations that promptly address non conformances demonstrate their commitment to continual improvement.
What is non-conformance management?
Non-conformance management is the process of documenting, investigating, and correcting issues or problems that have identified some deviation from the organisations policy, procedures, or a failure to meet the requirements of a standard. Recording non-conformances helps to manage risks, and later will assist with analysis of trends to help determine and eliminate the root cause of any recurring problems. CAPA include longer-term actions that ensure the issues will not occur again.
Since CAPA can be linked to risk management with the primary step in identifying the potential source of issues, their effects, and the likelihood of their occurrence. An analysis of the costs and best methods associated with reducing the risks can then occur. Drilling down into the reasons behind the issues arising is aso essential, using root cause analysis such as the ‘5 Whys’ (asking ‘Why’ something occurred 5 or more times) and selecting a soiution that fixes the root cause problem, and not just the symptoms.
Effective management of non-conformances and CAPA is an integral part of a continuous improvement plan of an organisation, leading to fewer defective products, processes or services and leads to more satisfied customers.
What are the challenges of non-conformance management?
Managing all the non conformances and where they are up to in their action and closeout can be a real challenge after the audit is over. Traditional non-conformance management systems keep track of non-conformities manually through registers, and communication trails managed back and forth via email. Where issues are not closed out or closed out in a timely manner there are real risks that problems are overlooked, and issues continue affecting the financial, procedural, and reputational loss that could have been so easily avoided with effective non-conformance management.
In a nutshell, the management, follow-up, and closing out of issues raised during the audit is often not as efficient as it could be, and this is one of the most significant disadvantages of the traditional auditing system.
How can automation help?
Automation helps organisations overcome the limitations of document, register and email based non-conformance management. Compliance audit systems incorporate non-conformance workflows that allow auditors and management to track non-conformities from their issue right through to closure. These systems also help store and access information required for effective investigation of a non-conformity.
Mobiom is the compliance audit management system that allows organisations to take control of the issues raised during audits. There is no need for non-conformances to be re-entered in the system after the audit report is completed. It also allows non-conformities to be classified according to their severity and the timeframe for their completion can be tracked and reported duly.
Using Mobiom, auditors can also support each non-conformance issue with evidence such as a photograph or attach a document. Audit site managers can enter their corrective actions directly, including photographs or attachments as supporting evidence of action taken. This enables the audit approver to access the audit non-conformance issues, approve the response, or ask for further information or corrective actions as deemed necessary.
Compliance audit management systems allow auditors and management to conduct effective audits and manage non-conformances through to completion. Organisations can benefit from using this automation and improve their processes.