Auditor interviews

Regardless of which assessment method you choose, assessors and auditors should take detailed notes using a common format to help capture maximum information in a consistent manner. Forms for questionnaires, topical outlines, and audit protocols (as shown in the exhibits) can perform double duty by providing interviewers with a format for notes as well as reporting. 

Encourage auditors and assessors to review and organize their notes as soon as possible after completing an interview or site visit. It s easy to lose track of insights and observations if too much time elapses, particulady when an assessment involves multiple sites. 

The EPA and FDA audit is a formal process involving advance notice, planning and scheduling (Figure 8.2), and a follow-up report, as well as the actual on-site observations and interviews. The advance notice includes an announcement of what specifically is to be audited. When the auditors arrive, the study director and lab workers are interviewed as a group, in what may be called an "opening conference," and the audit plan is laid out for everyone s full understanding. Included here would be a review of the purpose... 

Completing the Audit At the conclusion of the audit, an exit interview should be conducted so that all concerns can be immediately conveyed to staff. It is important to be aware of questions or concerns the auditors may have before they leave. A file of inspection documents should be maintained... 

Assignment of a lead auditor to take responsibility for the audit Reference documents to be used in planning and performing the audit A company organizational chart—to help understand the organizational flow and determine the proper individuals required for interview during the audit... 

Direct access to source documents is required for all studies - direct access means monitors, auditors, other authorized representatives of the sponsor/CRO and inspectors are permitted to view all relevant source documents needed to verify the CRF data entries. Other restricted methods of access to source documents (e.g. across-the-table , back-to-back , interview method ) are not acceptable, as they do not allow proper verification of the data in CRFs. To ensure direct access, the study subject consent form must clearly indicate that permission for access has been granted by the study subject. 

Quality-related methods and techniques Knowledge of methods applied in quality management, for example use of checklists and forms to record audit observations, sampling techniques, interview techniques, verification of information and writing audit reports must be acquired by the auditor. Communication skills, both oral and written, are essential for QA auditors to ensure adequate communication with auditees and management. 

Audit notes are indispensable to allow QA auditors to write an accurate report after the audit. Detailed notes allow the auditor to prepare a meaningful audit report which is based on verified observations. All information collected during an audit is considered audit evidence. Information sources in an audit are, for example, document review, interviews and observation of activities. If applicable, sampling techniques may be applied, for example for SDV and verification of information in tables and listings. Audit observations are only considered audit findings if it is determined after comparison with audit criteria that these are not or insufficiently fulfilled. And finally, audit conclusions can be drawn to assess whether the audit findings impact the validity of the clinical data and the safety of the trial subjects. 

Audits can take many forms but generally they will involve one or more interviews between the auditor and key personnel. The subject is posed a series of ques-... 

A critically important skill for an auditor is interviewing. In particular, he or she needs to be someone who can ask open-ended questions and is a good listener. As discussed in Chapter 12 (Incident Investigation) the auditor should listen to what people actually say, focus on facts not opinions, and establish trust with the people they are talking to. 

The auditor will have to work with a wide variety of people. He or she will be interviewing a full gamut of personalities and job descriptions, ranging from the facility manager to temporary workers who have no knowledge of the plant culture. This means that the auditor will have to be empathetic, i.e., he or she needs to understand where people are coming from, and what they can be expected to know. (Empathy is different from sympathy in that the auditor may relate to a person s concern but still retains his or her detachment and objectivity.)... 

The auditor should keep good notes that document the results of interviews, document reviews, and equipment testing. These notes will be essential for communicating findings. 

In addition to funding, quality personnel are needed. On the facility side, there will be some preaudit preparation. Typically, some of the necessary documentation will be collected and organized so that the auditor s time is not wasted. It may also be necessary to print fresh copies of pertinent documents. However, the major use of personnel time will be during the audit itself, when key personnel are interviewed and records are researched. 

An audit generally consists of a combination of interviews and review of documentation. Ideally the one verifies the other. For example, the auditor may ask an operator how he performs a certain task (the interview). Having been told, he will then ask for a written procedure that confirms this (documentation). Or the auditor may review a Material Safety Data Sheet (MSDS), and then ask... 

The auditor will have to be selective regarding the documents that he reads and the people who are chosen for interviews. There simply is not enough time to read and discuss everything. An experienced auditor will sense where the soft spots are and, based on the information received to that point, will use his or her experience to choose the follow-up questions. For example, if the operating procedures on the facility being audited are much shorter than the operating procedures on other similar facilities, he or she may choose to investigate this element with increased scrutiny. The shortness of the procedures may indicate that the facility has a deficiency in this area (or it may mean that they were very well written). 

The interview is at the heart of most audits (interview skills were discussed earlier in this chapter). The auditor systematically works through a series of questions with one or more of the people who work at the site. Typically, the process follows these steps ... 

The auditor asks the interviewee to describe his work. This gives the auditor a sense of the boundaries for this particular interview. 

During the interview the auditor must take notes, otherwise he will not be able to verify his findings. The note-taking should be as discrete as possible, so that the interviewee is not distracted or worried. 

In principle, voice recorders are an excellent way of capturing information during interviews. No matter how skillful the auditor may be at capturing statements in his notes, it is inevitable that he will miss some of the statements that are made. If the interview has been recorded, the auditor has an opportunity to go back and make sure that he captured all the information provided to him. In practice, however, recorders are rarely used because the person who is speaking may fear that any off-the-cuff comments could come back to haunt him. Consequently, the interviewees become very cautious to the point where they simply do not communicate the information that the auditor needs to do his job properly. 

After two years the company was awarded an international four-star safety rating from the National Occupational Safety Association of South Africa. Two auditors spent a week evaluating every elanent of the safety system, interviewing employees, and inspecting the smelter and other areas with a fine-tooth comb. That same week... 

Generally, findings fall into two categories—those directly in contravention with a stated rule or standard requirement, and those that should be noted to improve operations or safety. Both need to be coordinated with and approved by the audit team leader before being disclosed to the audited site. Each finding needs to have back-up justification with evidence. The evidence should be in the form of site records or the record of the auditor s interview with one or more site personnel. 

Put your best foot forward. From the first time the auditors enter the site until they leave, they should be favorably impressed. Ensure that the site is clean and presentable and that your best people are the walk-through escorts and are the ones interviewed. 

Rehearse. If nothing else, walk through the areas to be visited by the auditors and provide guidance to those being interviewed regarding how to conduct themselves (and to report back). 

Review and emphasize the ground rules. It is vital that both the auditor and the site personnel understand the audit ground rules. This is accomplished at the in-briefing. At that time discussion of schedule, the interview process, records to be reviewed, and finding takes place. 

During an internal audit or self-inspection, trained employees of the organisation check the functioning of the quality system. They may use structured questions and checklists with which they compare the information in the quality manual and connected procedures with the actual situation. An experienced auditor will also use a more intuitive approach for instance getting information about (lack of) cooperation between sections or departments, exploring peculiarities or interviewing staff. When discrepancies are found, they will usually be classified as critical, important or minor. Subsequently corrective or preventive measures (see Sect. 35.6.15) should be taken to adapt the actual methods or the documentation in order to make them match again. 

In an exit interview with informed management personnel, the auditor or audit team should anticipate, and prepare beforehand to respond to, questions comparable to the following ... 

The location coordinator should also forward to the lead auditor, an organization chart that is used to identify personnel the auditors may wish to interview. About two to three weeks prior to the audit, the lead auditor should identify all plant personnel they wish to interview. Once the location coordinator obtains this list of interviewees, they should begin setting up an interview schedule. It is best to interview management first, followed by first-line supervision, engineering, and then finally, maintenance and... 

Only by reviewing the procedures, interviewing the plant personnel, reviewing the records and conducting a field audit will the auditors gain the answer to these questions. 

Auditors should go into the interviews with a set of questions to encourage the interviewee to begin talking. The questions should be unique for the type of person being interviewed, e.g., the questions for management personnel should be different than what is asked of an operator. 

Air Monitoring and OSHA When an OSHA compliance officer audits your facility, if you have permit-required confined spaces that are entered by your employees the auditor will pay particular attention to your air monitoring procedures. Typically, the OSHA auditor will want to see copies of your confined space permits for the past year. From these permits, the auditor will choose one and set it aside. Later, the auditor will ask to interview those involved in making that confined space entry. The auditor may ask the confined space personnel several different questions related to their knowledge of confined space entry. The auditor may desire to see these per-sonnel perform the entry again. 

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