Audit procedures

Evaluation forms, MOC packages, audits, procedure changes, and test results are reviewed. (Feeds back to other phases.)... 

The audit team, through its systematic analysis, should document areas that require corrective action as well as where the process safety management system is effective. This provides a record of the audit procedures and findings and serves as a baseline of operation data for future audits. It will assist in determining changes or trends in future audits. 

The characteristics of the downstream pollution discharge must be monitored (see Fig. 13.18). It is essential that the operation and maintenance of the pollution control equipment be included in a quality audit procedure, assisting in determining the operation efficiency of the equipment and the formation of unwanted and possibly toxic compounds in the pollution control steps. Unsuitable operation of an incinerator may result in partial oxidation and formation of unwanted combustion products or excessive formation of MO. 

Once you have matched the policies with the procedures (a one-off activity), implementation is assured by verifying that the procedures are being adhered to by those to whom they apply. Simply auditing procedures will not ensure that policies are implemented unless you verify that the procedures themselves comply with the appropriate policies. 

Your corrective action procedures need to cover the collection and analysis of product nonconformity reports and the collection and analysis of process data to reveal process nonconformities. The corrective action provisions of your internal audit procedure need to address the causes of the nonconformities and you will need an additional procedure to deal with external audits, investigating the cause of any nonconformities and recording the results. The procedure also needs to cover the investigation of customer complaints as the previous requirement only deals with the handling of complaints. 

Produce audit procedures that cover products, processes, and organizations. 

Although the main thrust of the HSE work is directed to providing inputs to the CPQRA process, the audit procedure generates valuable qualitative information regarding both the quality of the overall plant management and also the specific human factors dimensions which affect risk. 

Develop a training program on source reduction opportunities, model source reduction auditing procedures, a source reduction clearinghouse, and an annual award program... 

Audit Procedures - to ensure that all RMP elements are being implemented... 

The QA unit should have written procedures (SOPs) for the conduct of inspections and audits. These procedures should incorporate all considerations for the review of electronic data systems. The QA unit SOPs should address the role and responsibilities of the QA unit in software development, purchase, and validation activities, in-process audit procedures for data collected on line, procedures for on-line review of data (i.e., what will be verified and how much data will be reviewed), and the procedure for auditing reports using on-line data. 

Raw Materials, Components, and Finished Product There is no audit procedure or an insufficient audit procedure exists test methods lack validation. 

The internal audit procedure is documented and it has to be understood both by the auditors and those being audited. The objective of the internal audit is to contribute to the improvement of the organization via the elimination... 

Current quality system models call for audits to be conducted at planned intervals to evaluate effective implementation and maintenance of the quality system and to determine if processes and products meet established parameters and specifications. International standards provide guidance on auditing [13]. Audit procedures should be developed and documented to ensure that the planned audit schedule takes into account the relative risks of the various quality system activities. Factors that can be incorporated into a risk-based approach to planning audit frequency and scope include the following [6] ... 

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. 

QA procedures - including auditing procedures and maintaining the master schedule... 

Does the QAU have SOPs describing inspection and auditing procedures ... 

The conduct of a chemistry-related good laboratory practice (GLP) laboratory inspection and data audit will be discussed in this paper. This will be accomplished fcy describing the basic audit procedure, then digressing into the objectives of an audit and the primary problem areas that have been experienced. 

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. 

Company has no internal audit procedures and no internal audits have been performed as required by 21, CFR 820.20 (b). This cit-... 

Systems of quality control and assurance, including self-auditing procedures. 

The proval is product specific - to best value for the price. The assurance of product quality and safety are of key importance. The more sensitive materials are, the more in details the whole auditing procedure has to go. For instance, producers of raw materials for baby food have to ensure traceability up to the farm and to the field where a raw material is produced. They also have to prove their capacity to instruct farmers to produce raw materials allowing European Nestis companies to comply with the newly implemented limits for pesticides in baby food, i.e. residues below 10 ppb. 

Computer validation should not be undertaken unless fundamental validation controls have been fully understood and implemented within the pharmaceutical or healthcare company s organization. Here we allude to properly qualified personnel, effective document management and change control systems, internal audit procedures, methods of managing the deviations from standard practice thereby exposed, and a culture of continuous improvement (see Chapter 4 for more details). Senior management must not fall into the trap of assuming through complacency or idleness that these controls have been fully instituted In most firms there is usually much that still needs to be done in these areas. Let us examine these controls a little more closely. 

Individual procedures can easily consume 10 to 15 days effort to produce, even with experienced staff. Use should be made of industry guidance when developing procedures, e.g., GAMP example procedures and IEEE standards. Where existing procedures are being revised to secure validation compliance, this estimate of effort could be reduced by about half. As recommended above, this should be supplemented with about 20 days effort across all the procedures, shared among a team of end users. The individuals should contain the core users who are involved in all the procedures in order to ensure consistency. Other end users on the team, however, can be seconded for the development of particular procedures in which they have a specific interest, or can contribute a particular skill or competence. For instance, an end user quality representative may wish to be seconded for the development of the Supplier Audit procedure. 

Are regular internal audits carried out Are auditing procedures documented ... 

Your firm failed to conduct quality audits at the intervals listed in your Quality Audit Procedure xxxxxxxx, to verify that the quality system is effective. ... 

Canada also initialed a Mutual Recognition Agreement with the EU covering good manufacturing practice (GMP) audits. Accordingly, once the equivalency of the Canadian and European GMP audit procedures have been established, products can enter the respective markets without the need of mutual inspections of the producing facilities in each other s territories. 

At the same time, internal quality control must be carried out to verify the performance stability of the limited-scope performance of the method. Triply redundant verification methods are carried out with regard to control of first, second and/or third line, each set of methods applied to a particular type of test. The first line of verification involves pro forma repetition of all the steps of the test, in order to establish repeatability or reproducibility for quantitative tests, and to verify the range of sensitivity or detection for qualitative tests. This verification is performed by the experimenter himself, as part of the proper performance of the test. A second line of verification is put into operation by administrative decision, and includes testing with blind samples, repetition of samples, internal audit procedures, etc. If necessary, a third line of verification can be set up by the use of certified reference materials (or spiking materials), or through collaborative trials. These procedures are based on external cooperation. External audit procedures and complaints handling procedures are also part of this third line of verification. 

Induction training in QA may comprise the general audit procedures employed at the company, key audit SOPs and documentation requirements in QA. A thorough review of the regulatory framework for GCP is recommended, as QA auditors are expected to be experts for clinical trial regulations and all GCP aspects. It would impair the QA auditors credibility if they knew less than the auditees of the requirements that must be adhered to in drug development. 

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