First Impressions

First Impressions—The Plant TourPaul L. Pluta, Editor
Welcome to “Audit 101.”This feature provides useful and practical information that addresses various topics associated with audits.Audits are an important part of daily operations in the pharmaceutical, medical device, dietary supplement, and other regulated industries. The most critical audits are conducted by government regulators from domestic and international agencies. Audits may also be conducted by industry customers and internal compliance groups. Audits may be planned or unannounced. Government agency auditors may arrive at a site being audited without prior notification and then conduct a thorough audit. Successful manufacturing and quality assurance functions have carefully addressed the various activities associated with audits. These activities have been well planned and developed. They have evolved and been improved based on actual experiences. Successful organizations have policies, procedures, and systems in place that ensure well executed administrations of audits.Successful approaches to the various activities associated with audits will be the content of “Audit 101.” We intend “Audit 101” to be a useful resource for readers that will provide valuable information and will help improve audit administration and performance. The sources of information provided in “Audit 101” will not be revealed. Keeping the names of contributors to this feature anonymous facilitates openness, avoids confidentiality issues, and otherwise enables a free flow of information. Reader comments, questions, and suggestions for discussion topics are needed to help us fulfill the column objective. Please send your comments and suggestions to column coordinator Paul Pluta at paul.pluta@comcast.net.KEY POINTSThe following key points are discussed:
One of the first significant and critical activities conducted in an audit is the plant tour. The plant tour is a critical activity that must be considered to be of utmost importance.
There are many overlooked items on the plant tour that can negatively affect the entire audit. Experience has shown that seemingly trivial items can lead to serious audit consequences and observations. A listing of potential overlooked items is provided.
The plant tour should be carefully planned, evaluated, and practiced long before it is actually needed in an actual audit.
The tour leader is a key person on the tour.
The tour leader should speak the native language of the auditor if possible, have good communication skills, and be knowledgeable of all plant operations. Technical competence is important but is not the sole criterion for leading the tour.
Several important considerations such as knowing auditor objectives, plant clothing requirements, and other topics to be addressed during the actual tour are identified.
The plant tour should represent the condition of the entire plant. Auditors must have a positive impression of the plant when the plant tour is completed.
INTRODUCTIONOne of the first significant and critical activities conducted in an audit is the plant tour. The plant tour usually occurs after presentation of credentials and introductions of site and audit personnel. A short opening meeting describing the specific objectives of the audit (e.g., good manufacturing practice [GMP], pre-approval inspection, complaint investigation, etc.), scheduling, and so on then follows. The plant tour provides a broad overview of the site operations, both in technical manufacturing and regulatory compliance. The opening presentation associated with the tour can be used to help “set the stage” for the audit team. In addition to preparing them for what they will see on the tour, it can also be used to familiarize the audit team with the company, the specific manufacturing site, and organizational structure.There is usually a time and a place that one can pinpoint the exact moment the regulatory inspection takes a turn for the worse. At any cost, this must not happen on the opening plant tour. The entire tone of the inspection process is greatly influenced by what the inspector sees while on tour. An experienced auditor will make important judgments about the site based on the tour experience. If the plant tour is done well, these judgments will be positive. The plant tour is critical and must be considered to be of utmost importance. Planning, evaluation, and practice of the plant tour should be conducted long before a tour is needed in an actual audit.If bad things happen on the plant tour on day one, what can be expected for the rest of the audit? The plant tour is definitely not a perfunctory or superficial exercise.
The Plant Tour Represents the Entire PlantThis discussion focuses on the plant tour. It describes potential problems and an approach to assuring a successful plant tour. However, readers must not infer that areas in the plant tour are special or should be different than non-tour areas in the plant.The “audit readiness” mantra is typically lost on the specific tour route. This approach thoroughly cleans the corridors and room on the tour route, making sure all of the “sins” are sufficiently hidden away. Only the best and brightest employees will be working when the tour is conducted. The tour route is freshly painted and literally “shines.” But what happens when the auditor wants to go into an area that is not on the planned tour route? Or when he looks in a closet off the tour route?The plant tour should demonstrate the function and compliance strategy in the entire plant. The plant must have a culture of audit readiness in all areas at all times.The following are two axioms that are particularly applicable to the entire pharmaceutical or medical device plant:
“A place for everything and everything in its place”
“Cleanliness is next to godliness.”
These axioms must be demonstrated not only in the plant tour but also in all areas of the plant. Do not neglect the readiness of the entire plant–every day and all the time. The plant tour represents the entire plant.