Leveraging Your NSF Certification: Now that you've received NSF Certification ... why not leverage the Mark to your advantage.
This article summarizes a piece by Dr. Bob Pietrowski, Managing Partner of NSF-DBA, published in a special auditing edition of The Journal of NSF-DBA (page 3).
The audit or self-inspection is one of the most important elements of any quality assurance/quality management system. It is essential that all aspects of our activities be challenged on a regular basis to determine that premises, environments, practices, procedures and standards are:
A well-conceived and professionally executed audit delivers numerous important benefits over and above simple regulatory compliance:
The essentials for an effective audit program are the audit schedule, the trained auditor, the audit plan, the audit report and the audit follow-up.
As audits cannot all be performed at once, we have to prioritize based on risk--to the patient, to the product and to the business. If you attend to these, the risk of regulatory action is automatically taken care of as well.
That risk assessment should determine which activities to audit first, the duration of the audit and the audit frequency. The audit schedule should then be agreed upon, approved, communicated, adhered to and modified as needed.
Auditors are an extension of the quality system. Their task is to limit risk to the patient through prevention of errors. An auditor has three main roles:
The auditor should never be viewed as a police officer applying punitive measures.
An effective auditor should ideally be qualified in the underlying science and technology and be fully conversant with processes and relevant standards associated with the audit activity. Auditors should have a clear understanding of their company’s business objectives and products. They should be able to see their role within the broader quality management and business management systems and act in the best interests of both.
The auditor must be receptive to new ideas and ways of doing things, and be comfortable talking with all levels of employees. This is echoed by ISO 19011, Guidelines for Auditing Management Systems, which state that auditors should have integrity, be fair, exhibit professionalism and confidentiality, be independent and be evidence-based in approach.
Audits should be conducted in a structured and systematic way, and that requires some sort of plan. Some companies favor the audit checklist, a structured list of questions for use in auditing a specific department or activity. A checklist ensures all activities are covered and delivers consistency between auditors and between audits.
Other companies prefer the audit aide-mémoire, a list of key words and phrases that the auditor can use to shape the audit. This method also covers important issues while providing a degree of flexibility. It allows the auditor to move on quickly if procedures are satisfactory or to concentrate on areas of concern.
An audit report is one of the few lasting records of the audit activity and is crucial to the assessment of acceptability as well as follow-up and remediation. The report must be written in an agreed-upon format and should cover at least the following:
Follow-up is key to assurance of quality and should include:
If you think NSF-DBA can help your company by providing class leading training for your auditors or by performing audits on your behalf around the globe, please contact us, mail@nsf-dba.com.