Quality audits report

The standard requires suppliers to define the type and extent of control exercised bp the supplier over subcontractors and goes on to require that these controls be dependent upon the type of product, the impact of the product on the quality of the final product, and, where applicable, on the quality audit reports and/or quality records of the previ-ousty demonstrated capability and performance of subcontractors. 

Examples of Quality Audit report forms are shown in Tables 9.5 and 9.6 at the end of this chapter. Table 9.5 shows Report Form 1 which includes a record of what has been examined, so that subsequent audits can examine other aspects of the laboratory s operations. Note that when improvement actions are required, the form records not only what needs to be done, but also by when it must be completed, as shown in Table 9.6 (Report Form 2). The form is signed by the auditor and the responsible person from the area being audited. In the UK, the accreditation body UKAS refers to the corrective action as improvement action . This further emphasizes the continual improvement aspect of the ISO/IEC 17025 and ISO 9001 Standards. The examples shown in Tables 9.5 and 9.6 will probably have to be modified to meet a laboratory s particular requirements. It should also be remembered that both report forms should indicate (usually as a footer or header) the title of the document, its issue date, issue number, who authorized the document, page number and total number of pages. 

Figure 9.4 Quality audit report In three parts (1/3, 2/3 and 3/3).

In addition to fulfilling the in-house requirements for quality control, state and local air monitoring networks which are collecting data for compliance purposes are required to have an external performance audit on an annual basis. Under this program, an independent organization supplies externally calibrated sources of air pollutant gases to be measured by the instrumentation undergoing audit. An audit report summarizes the performance of the instruments. If necessary, further action must be taken to eliminate any major discrepancies between the internal and external calibration results. 

Planning, conducting, and reporting on internal quality audits (clause 4.17.1) Identifying training needs and providing training (clause 4.18.1)... 

Subcontractor/supplier performance will be evident from audit reports, surveillance visit reports, and receipt inspections carried out by you or the third party if one has been employed. You need to examine these documents for evidence that the subcontractor s quality system is controlling the quality of the products and services supplied. You can determine the effectiveness of these controls by periodic review of the subcontractor s performance what some firms call vendor rating . By collecting data on the performance of subcontractors/suppliers over a long period you can measure their effectiveness and rate them on a scale from excellent to poor. In such cases you should measure at least three characteristics quality, delivery, and service. Quality would be measured by the ratio of defective conforming products received delivery would be measured by the number of days early or late and service would be measured by the responsiveness to actions requested by you on scale of excellent to poor. The output of these reviews should be in the form of updates to the list of assessed subcontractors/suppliers. 

Customer complaints Warranty claims Failure analysis reports Process capability studies Service reports Concessions Change requests Subcontractor assessments Performance analysis Deviations and waivers Contract change records Quality cost data External Quality Audit records... 

The types of records needed to demonstrate adherence to requirements and standards as well as effective operation of the quality (ESH/PSM) management system are covered in this element. In addition to many of the quality records listed (e.g., inspection reports, audit reports, operational procedures, and drawings), ESH/PSM requirements might include training records, permits, hazard analyses, audit and other response plans, and accident/inci-dent investigation reports. 

The audit plan should be consistent with written quality auditing procedures included in the quality manual or other quality system documentation. The plan should include or refer to the objective criteria to be used to evaluate conformance to requirements. The plan should include or refer to other documents that will be used during the audit, including previous audit reports. If the audit is to include the review of batch or production records, such review should be conducted in accordance with a specified sampling plan or other appropriate statistical rationale as specified in a firm s quality system procedures. 

Corrective and preventive action (CAPA) is the term commonly used to describe the subsystem of a comprehensive quality system that deals with the systematic investigation, understanding, and response to quality issues including nonconformities. A corrective or preventive action may be initiated based on review and analysis of quality data from a variety of sources including adverse experiences, product complaints, quality audits, FDA inspections, third-party inspections, nonconforming materials reports, process control information, trend analyses, and other sources. 

Supplier prequalification response Supplier audit report Project and quality plans Software quality assurance plan Commercial and purchasing specs. 

Audit Report. A report of an independent audit of the computer validation process by an internal auditor (i.e. Quality Assurance) should be included with the summary report to management. The audit should compare the SOP and the initial parts of the protocol (what the system should do) with the test plan results (what the system actually does) and the summary report conclusions. 

Quality Assurance Section representatives periodically attend staff meetings of each section that does work subject to the GLP regulations to discuss quality assurance concerns. It has been much easier to get compliance by discussing problems than to simply make recommendations in audit reports. 

The assessment of project activities may include performance and systems audits, data quality audits, peer review, PE samples, as appropriate for a given project. Assessment enables project personnel to identify field and laboratory problems or variances from the project scope and to implement timely corrective action. The findings and response actions originating from assessment activities are documented in reports to management. 

Standard procedures for conducting the quality audit should also be addressed in the Vendor qualification program. An audit cycle includes the preparation of an audit, performance of the audit, reporting of the results of the audit, and audit closure or follow-up requirements. Figure 2 illustrates the audit process. 

Audit report titles should reflect a more enlightened and proactive approach to auditing something like the GMP enhancement plan or quality and compliance improvements might serve to motivate employees and enlist executive management s support rather than the cold audit report. 

A typical way to perform a quality audit is to select a group of samples that have been tested, follow their progress through each stage of the analytical process, including all aspects of the analysis from the receipt of the samples to the final report to the customer. This is called a vertical audit. 

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. 

GxP data, records, and documentation including computer vahdation should be archived. Internal audit reports from self-inspections monitoring a pharmaceutical or healthcare company s compliance with its own quality management system do not have to be retained once corrective actions have been completed, so long as evidence of those corrective actions is kept (e.g., change control records). Supplier audit reports and periodic reviews are not internal audits and should be retained. 

Supplier Audit Report Supplier Quality Certificates Purchase Order... 

Confirms that quality procedures matches practice (audit report)... 

Audit reports should avoid the detailed specification of corrective actions. It is the supplier s responsibility to define how observations will be addressed within the context of the supplier organization and quality systems. 

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. 

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