An effectively functioning Internal Audit Process is a showcase of the company both as the conformity of your QMS (according to ISO9001, ISO13485, ISO15189), but also in relation to effective company management, its processes, systems and the company approach to continuous improvement and/or inspection readiness.
Internal audit, often called self-control of the organization, focuses on independent, objective and impartial verification of the compliance regarding legal regulations, GMP, GDP, GDL, Data Integrity requirements and international standards, and also verification whether the Quality Management System is effectively implemented and maintained.
The basis of the process is a well-structured annual audit schedule, which guarantees that the assessment frequency of each area, process or system in the organization has been determined based on several topics, e.g.:
- The impact on product quality
- The number of implemented changes
- Remarks from External Audits and Inspections
- Recommendations from previous Internal Audits
At the same time considering the number and competence of internal auditors, which is a key in the effective functioning of the Internal Audit Process and achieving the resulting benefits.
A transparent audit plan should not only systematize the thematic blocks and audit time frames, but also define the scope, purpose and criteria of the audit necessary for the correct conduct of the process. Its consultation and reconciliation with the audited area managers/ SMEs is necessary to achieve the proper audit readiness and to include all suggestions in reference to the verification of important aspects as recent changes or investments in the audited areas, which gives added value to the area owners, and to the entire organization.
The success of effective internal audit is based on an open atmosphere and professional honesty, and a good auditor, independent of the audited entity, bases his conclusions only on authentic evidence (records, observations, conversations), always referring to the pre-defined audit criteria.
All observations should be clearly and precisely described in the audit report and the identified nonconformities must always refer to the audit criteria and be within its scope. The report should contain clear information whether the audit objective has been achieved. Thanks to that and with auditor help, area/process/system owners are managed to define and implement effective CAPAs: corrective actions to eliminate/ reduce nonconformities in an audited area, while preventive actions allow to mitigate the potential occurrence of this nonconformities in other areas of the organization, thus sealing and improving internal processes, and increasing the readiness for External Audits and Regulatory Inspections. In addition, through Internal Audit, organization can identify the good practices and extend them to other areas in the organization!
Another proof of the implemented and maintained QMS in the company is the ability to continuously control, assess and monitor suppliers of processes/products/services to ensure the quality of the delivered product, its compliance with requirements, its safety, the supply continuity, and thus customer satisfaction and continuous improvement. The main way to achieve this is periodic supplier auditing which provides organization with proof that the supplier meets requirements including in the agreement. The Supplier Audit Process is a tool to achieve the documented control over suppliers, which is often an aspect verified during Regulatory Inspections.
Would you like your organization to have an effective QMS, meet regulatory requirements for the products and services, constantly improve, be inspection ready, meet customer expectations and be competitive on the market?
Ensure that the Internal and Supplier Audits Process is effective and we, as Rescop Turnkey & Advisory, can help you in this!