Audit Checklists

Table 15.18 Basic safety audit checklist for loading/unloading non-pressurised hazardous liquids tankers or tank containers...

The effectiveness of a QA-related independent Part 11 audit is dependent on the checklist or audit plan utilized. Here, provided as a model, is a two-part audit checklist. The depth of the evidence and support required is dependent on the results of the risk assessment All high-, medium-, or low-risk systems should be subject to the same general questions. 

Following is the generic audit checklist of which the personnel working in the pharmaceutical industry must be aware ... 

Since current quality system models employ a systems approach, an audit checklist that is organized by subsystem may be helpful, as described in Table 5. The form would include appropriate document control information such as form... 

Company Name] Quality System Audit Checklist ... 

The adequacy of any procedures is subject to the interpretation of the auditor. Therefore, the author accepts no liability for any subsequent regulatory observations or actions stemming from the use of this audit checklist. 

Questions from the self audit checklist, used as the basis for the WRAM s checklist, were reworked into a question and answer format. 

ELECTRONIC SIGNATURE AND ELECTRONIC RECORDS AUDIT CHECKLIST FOR A CLOSED SYSTEM... 

Purpose State the company and division that was audited—when, where, and by whom. List audit team members by name, title, and department. List key representatives of the developer company. Overview Describe focus issues. Summarize findings. Refer to the audit checklist for more detailed notes. Note that audit observations require a response/action plan from the software summary. 

Formal notification should include a copy of the audit plan, the audit checklist, and a proposed agenda. The audit team leader should also provide a copy of this audit package to the audit team members in preparation for the audit. 

All stages Management and safety system audits Checklists Feedback from workforce... 

With the increasing emphasis in quality to all facets of a petroleum and chemical operation, a quality assurance (Q/A) audit checklist should be completed as an essential final step in the review meeting. This helps ensure that an adequate review occurs and that project quality objectives are being met. A suggested checklist is provided as part of this publication as Appendix B. 

Any exceptions to the checklists should be explained on the form. Both the Team Leader and Project Manager (or Project, Facility, Process or Drilling Engineer) should sign-off the audit checklist. The checklist is added to review report as a quality verification of the review process. 

Howard Garston-Smith, formerly of Pfizer, has published a book on software quality assurance. It provides a postal audit checklist reproduced in Appendix 7C. If the supplier has already prepared an internal ISO 9000 mapping or an internal audit report on how it aligns to industry standards such as the GAMP Guide, this can be offered as an alternative to the auditor s postal checklist. A reduced postal checklist may be agreed upon, at the very least. Wherever possible, photocopies of actual example documents and test records should be inspected for documentary evidence of validation. Remember that the pharmaceutical and healthcare companies are themselves being inspected for documentary evidence of validation. 

Auditors should agree to response times with suppliers when using the postal checklist. Busy contract periods, illness, holidays, and staff turnover may all delay the responses. Before agreeing to a response time, suppliers should ask to see a copy of the audit checklist so that the amount of work needed to reply can be gauged. 

The key to the process is to understand the system that is being proposed. It is good practice for the auditor to spend time reviewing the User Requirement Specification and the system descriptions and understanding of what software categories exist for the proposed system. This should be followed up, with the postal audit checklist. This will also provide valuable information to enable the auditor to plan the audit. Available information should be used to customize the audit checklist to address the specific issues that are relevant to both the supplier and proposed project. Consider, for example, a system that includes hardware and software, where some of the software is custom, other parts are configurable and yet others are part of a standard package. The auditor will need to establish how each part of the system will be developed, and how the build phase will be controlled. There may even be more than one supplier. The auditor would need to split up the main elements and examine how each part of the system will be built. 

---