Quality Assurance Audit...

The primary objective of a Quality Assurance Audit is to gather information related to the on-going status of a process and then applying the information gathered to evaluate the performance of the process against defined criteria. When performing an audit you are reviewing the activities, the records, processes, systems, user experiences, competences, etc., in place and seeing how they compare to expected standards of performance, customer expectations, design expectations, etc..


Quality Assurance Auditing – Definition.

“A quality assurance audit is a documented, systematic process, performed in a planned manner by competent independent personnel with the objective of evaluating the application by an organization to the principles and requirements of defined quality regulations and customer expectations”.


Key objectives within the Quality Assurance Auditing process:

1) An audit is a ”benchmarking process”, i.e. an audit will give a status of the current performance of a process. This status can be measured against a published standard, or versus an approved operating procedure, versus a peer department, versus competitor companies, etc..

2) An audit should be utilized as a method for driving improvement. The audit may identify shortcomings in process performance, may identify changing trends in performance, may identify deficiencies in staff knowledge or competence. Any such findings can then become the basis for improvement activities.

3) The quality audit should be a means of standardization. By implementing an audit program, equivalent standards of performance can be developed across different functions. The knowledge gained can be applied to ensure procedures are consistently utilized or equivalent competence requirements are set for staff. In the wider community, regulatory bodies for example use the quality assurance audit, to ensure quality standards are consistent across different product manufacturers.

4) The quality assurance audit is frequently applied back through the supply chain, where purchasing organizations utilize audits to force minimum quality standards on suppliers. Frequently a supplier cannot become “approved to supply” a product or service, without first having passed the audit and addressed any shortcomings in their quality management system.

5) Learning and Training. A key point to understand as part of the audit program, is the potential for learning and knowledge transfer during the audit process. Where the auditor has a good understanding of the product or process, he / she can use the audit as a form of training for the person being audited. By explaining the reasons for particular requirements, or test points, or record requirements, the person being audited can personally develop their process or product knowledge.

6) Regulatory and standard compliance. The audit will confirm the compliance status of a process or product versus applicable regulatory or standard requirements. The audit can expose any gaps against requirements, which can then be addressed.


Internal and External Quality Audits.

Internal audits are usually performed by the internal quality assurance function within an organization and cover any functions or activities which may impact product quality. The internal audit program of an organization frequently includes the supplier audit program.

External audits are normally seen as audits imposed on an organization. These may come from regulatory bodies or from bodies which have the authority to issue certifications, e.g. ISO 9001, ISO 14001, ISO 13484, etc.. For a business which provides products and services into another commercial business, then the purchasing organization may impose minimum standards of performance on the supplier, which is confirmed via a supplier audit program.


The audit schedule.

Audits are normally planned in advance, many organizations complete detailed annual audit schedules. Good practice is to have a less detailed audit program looking forward say three years, which helps in the planning of audit resources and can demonstrate alignment of the audit function with the business strategy.

Audits will normally be planned based on criticality. This criticality is related to the potential risks identified. Best practice is to have a risk management process in place which identifies the various risks to an organization, these may be safety, quality, reliability, financial, reputational, etc.. Audits are then planned in accordance with the risk levels identified. The greater the risk, then the more frequent and more detailed the level of audit performed.


Audit closure.

At the end of the audit, it is normal practice for the auditors and key auditees, to review the audit findings and agree on the next steps. The objective should be to aim for agreement, even where deficiencies are found. However, agreement may not always be possible and in such cases the auditors must clearly outline any concerns they have, the reasons for the concerns and their expectations in terms of actions to be taken to address.


Quality Assurance Auditing. Reporting the audit outcome.

A key part of any audit, is a clear report of findings. A report would normally contain details on the objective and scope of the audit, the dates the audit was performed, the names of all those who performed the audit, plus the names of any individuals who were audited. The standards, procedures, specifications applied or referenced during the audit. Details on the audit trail, i.e. what happened during the audit. Any observations, deviations from expected practice or recommendations, will be documented. There should be an audit summary and conclusions.


Audit follow-up.

Upon completion of the audit, where deficiencies have been identified, corrective action(s) will be issued, or if already issued by the time the audit report is formally published, the report will reference the corrective action numbers. The corrective actions will then be tracked to closure via the CAPA (corrective and preventive action) process. Where critical deficiencies were identified, then a follow-up audit may be necessary.

Quality Assurance | Quality Management Systems.

          • The Principles of Quality Management
          • The Quality Manual
          • Quality Standards and Specifications  
          • The Quality Management System
          • Revised requirements of ISO 9001: 2015  
          • Design Quality – Products & Processes  
          • Good Manufacturing Practice (GMP)
          • Documentation
          • CAPA – Corrective And Preventative Action
          • Calibration Certification
          • Change Management and Control  
          • Quality Management Training
          • Product and Process Validation  
          • Supplier Quality Assurance
          • Audits & Auditing
          • Ensuring the Quality Management System is Risk based
          • Etc. …. Etc. …. Etc. …
          • Quality Assurance | Quality Management   >>>