Audits/auditing Audit Protocols

The second aspect of quahty documentation is to detail how the work processes referred to in the manual are performed. The QA unit is often the organization responsible for issuing a set of procedures designed to assure conformance to the appropriate standards or to company poHcy. The procedures, often called standard operation procedures (SOP) or quahty operating procedures (QOP), should include such topics as customer complaints, audit protocols, stabihty testing, preparation of COAs, test method vahdation, etc. 

The level of team members effectiveness depends on skills, experience, and the guidance they follow. A formal audit protocol provides the user with step-by-step instructions on how to conduct the audit, and thus can be used by less experienced auditors. Use of less formal assessment guides such as topical outlines requires more experienced auditors. Either way, the skill level of an audit team must be sufficient to enable members to ... 

Examples of an audit protocol and a topical outline are provided in Figures 4-3 and 4-4. Whichever audit tool is chosen, it should be used consistently for all audits. 

FIGURE 4-3. Example Page from an Audit Protocol Format (page 1 of 17)... 

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. 

Audit protocols are tailored to their subject and to the answer desired of the audit. CCPS (1993a) provides more details on audit planning, audit protocols and teams, and other audit issues. 

This table may also be incorporated into the PSM program assess-ment/audit protocol and used during periodic PSM program evaluations.9)... 

Have audit protocols been established that include examination of effective implementation of -Investigation follow-up measures -Recommendations ... 

When the first draft of a protocol is typed, it is sent to the Quality Assurance Section to be audited. The protocol is checked for those details required by the Good Laboratory Practices guidelines. Comments about each protocol are sent to the study director. When the final version of the protocol is typed, it is again sent to Quality Assurance for review. The original copy of the signed and dated protocol is filed in the archive. 

The appropriate response to this observation would be for the firm to revisit its supplier qualification policy and procedures to ensure that they meet current regulatory requirements as well as internal quality standards. Second, the firm will present the agency with a package of new and improved procedures and an umbrella policy related to a state-of-the-art vendor qualification program. These procedures will ensure that all critical suppliers are audited and monitored appropriately in accordance with predetermined criteria and audit protocols. Audit protocols will be designed to meet the unique aspects of every supplier. 

External audits of raw material suppliers and contracted services should be handled in much the same way as the internal QAP. Audit protocols should be customized and tailored to the specific organization to be audited. For example, an assessment of a contract laboratory service should be conducted under the auspices of the internal audit team and follow similar procedures in terms of identifying deficiencies, installing corrective and preventative measures, and reports issuing. It is an advantage to employ the same personnel for both the internal and external audits. This approach assures a standardized and uniform audit procedure across the board. 

Application of these procedures to future work will yield transformation rate data of known precision. Additional audits and protocols are necessary to derive data accuracy and validity. One of the shortcomings of previous experiments is they provide only a value of the observable while neglecting these three attributes. The institution of this methodology to chemical transformation data obtained with this system would yield results with known uncertainty for use in models of atmospheric chemistry and physics. Application of the general methodology which comprises the overall measurement process is important not only in the context of measured transformation rates but also in all experiments and programs where the collection of quality data is desired. 

Select the audit protocols, checklists, or guides to be utilized during the audit. This should include how the selected document was developed, approved, updated, and retained for future records. 

Protocol Audit An audit of the protocol for this swdy was conducted and reported to the Study Director and Company Mana emeut as indicated above. 

Hill P, Taylor E. An auditable protocol for treating attention deficit/hyperactivity disorder. Arch Dis Childhood 2001 84 404-9... 

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