Process validation provides documented proof that a process delivers predefined results and does not pose a risk.
A quality audit is a systematic and documented examination procedure from quality management that is carried out by specially trained auditors. It checks whether a company's processes, activities or systems comply with defined standards, guidelines, norms or laws. The methodology is based on ISO 19011, the international guideline for auditing management systems.
Quality audits are usually part of a quality management system, but are also often regulated in contractual agreements (e.g. contract, quality assurance agreement). They are important in order to:
The term audit is very often associated with a (QM) system audit. However, if one considers the general character - namely the examination of the correct implementation of specifications - there are inevitably numerous types of audit, such as
ISO 19011 is an internationally recognized standard for quality audits of management systems. These can be quality management systems or information security management systems. The standard applies to companies that audit their management systems.
According to ISO 19011, the risk-based approach is the basis for quality audits. It looks at risks and opportunities and takes into account the planning, implementation and follow-up of quality audits. The aim is to achieve continuous improvement.
A basic distinction can be made between internal and external quality audits. In internal audits, processes within a company are checked by the company's own employees with the necessary expertise. External audits, on the other hand, are carried out by external parties.
A distinction is also made between 1st, 2nd and 3rd party audits:
Quality audits play a crucial role in ensuring quality, safety and regulatory compliance in the life sciences industries. Here are the specific roles that quality audits play in each industry:
More about quality audits in the food industry
A distinction is made between internal and external quality audits. External auditors come from an independent certification body and must be trained and tested for this purpose. Internal auditors are not subject to any fixed regulations. Neutrality and the necessary knowledge of the subject are prerequisites; experience in quality management is usually helpful.
Even though quality audits are individual to a certain extent, they always follow a similar pattern:
What is the reason for conducting an audit (e.g. internal audit, as part of supplier qualification, etc.)? The definition of the basis for the audit (e.g. rules and regulations, corresponding SOPs, etc.) and the appointment of the audit team and the audit manager are also important topics in the preparation. Other preparation topics include the audit date, audit objectives and the audit plan.
The audit is carried out in accordance with the audit plan. In addition to all discussions, questions and explanations, it is important that statements are also substantiated (e.g. with corresponding documents). After consulting the auditors, a final meeting is usually held with representatives of the audited party.
The audit report contains audit findings, audit conclusions and - but marked as such - recommendations from the quality audit carried out. Audit findings are the results of the evaluation of the collected audit evidence and show conformity or non-conformity with regard to the rules and regulations. The conclusions are then the result of an audit after taking into account the audit objectives and all audit findings. The audit report is usually sent to the auditee with the opportunity to comment before finalization. It is then finalized.
The auditee proposes specific measures based on the audit report to remedy the deficiencies found. In the case of an internal audit, the implementation of the measures can be determined internally. In the case of external audits, a review is carried out by means of corresponding reports or a re-audit after a certain period of time.
With our Yaveon 365 industry-specific ERP solution, companies in the process manufacturing industry benefit from a range of functions that generates maximum automation. This also facilitates successful quality audits.
The following functions are particularly helpful here:
Process validation provides documented proof that a process delivers predefined results and does not pose a risk.
An audit trail documents the correct execution of processes and strict compliance with all defined steps in a complete and electronic manner.
A food audit involves the inspection of manufacturing, processing and distribution processes in the food industry for quality assurance purposes.