Quality audits schedule

The EPCM contractor QA manager shall prepare and update a quality audit schedule. Figure 9.2 proposes a suitable format. This facilitates management of the over all audit programme. 

The technical package may specify a scope and frequency for periodic audits and performance criteria that could lead to changing the audit frequency. It may be a general safety and environmental performance audit or a special audit for items such as raw material storage and handling, quality control methods and documentation. The proprietary nature of a process or product or the complexity of the toll could be a reason to establish a more frequent audit schedule for certain tolls. Audits can also be conducted to follow-up on previously identified shortcomings to document that they were addressed properly. 

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] ... 

Auditing as described in QMS models is intended to assess the effectiveness of the overall quality system as designed and conformance to applicable standards. The overall quality system does not have to be covered in a single audit. Manufacturers may choose to employ a rolling audit approach in which specifically identified subsystems are chosen for evaluation in accordance with an approved audit schedule. Audit plans should be designed to effectively perform this assessment. 

A quality manual has to document those procedures and policies that are carried out in the laboratory that can affect an analysis. In addition details of the organisational relationships, responsibilities and authorities of all of the more senior staff and the internal auditors are described. The manual will probably include descriptions of the resources of the laboratory, examples of records used, calibration and audit schedules, and routines such as the periodic review of the quality system. 

It is common practice for a senior member of staff in the laboratory, often known as the quality manager, to have the resi onsibility of ensuring that the quality system is kept up-to-date. He or she will also ensure that periodic and systematic reviews of the system are conducted, and that an audit schedule, a timetable of when audits are to be performed, is prepared. An audit may highlight instances when practice deviates from the documented procedure. The quality manager must ensure that these digressions, known as non-compliances or non-conformities, are rectified within a timescale agreed with the auditor. 

The excipient manufacturer should carry out a comprehensive system of planned and documented internal quality audits to verify whether quality activities comply with planned arrangements and to determine the effectiveness of the quality system. Audits should be scheduled on the basis of the status and importance of the activity. The audits and follow-up actions should be carried out in accordance with documented procedures. 

It has to be shown by means of internal audits, that the operation (i.e. the daily work in the laboratory) is in compliance with the quality system. This must be stated in the quality manual A schedule has to be defined and a standard procedure for internal audits has to be prescribed. 

Preparation In preparing for an audit, all data and documentation for the study are assembled for the inspectors to view (Figure 8.3). The study director, or other designated technical contact, should review the files and prepare to answer any questions. The master schedule and all files assembled by the quality assurance unit should be reviewed. An agenda, a work space, and a test facility floor plan should be prepared for the inspectors. The staff should be fully briefed and prepared for the visit. 

Auditors should select the audit method most appropriate for their intended audit purpose. Initial quality system audits or regularly scheduled audits are likely candidates for the top-down approach, while audits conducted as part of a root cause analysis, for example, may best employ a bottom-up approach. The FDA employs a similar approach to inspections. Regular scheduled biennial inspections are more likely to employ a top-down methodology. For cause inspections conducted in response to a specific product issue such as a recall are more likely to employ a bottom-up approach. FDA investigators may employ a combination approach during biennial inspections if investigators are aware of specific quality problems that they wish to include in the inspection. 

The principles of GLP require an independent quality assurance (QA) program to ensure that the study is being conducted in compliance with GLP. The QA personnel cannot overlap with those of the study because of the potential conflict of interest, but they may be part-time staff if the size of the study does not warrant a full-time QA section. The responsibilities of the QA unit are to maintain copies of plans, standard operating procedures, and in particular the master schedule of the study, and to verily, in writing, that these conform to GLP. The QA unit is responsible for inspections and audits, which must be documented and the results made available to the study director and the principal investigator. The QA unit also signs off on the final report. Any problems discovered or corrective action that is recommended by the unit must be documented and followed up. 

Schedule the audit with the vendor to ensure that key development, quality, and management personnel will be onsite and available to the audit team. Verify how much on-site time the vendor will allow. Make sure that the goals of your audit can be completed in the allotted time. Schedule a closing meeting with key developer personnel for the end of the audit. Your company... 

Additionally, every vendor qualification program should include provisions for quality planning. This allows the sponsor to plan for audit events across project schedules. Vendor qualification for any project can be divided into two sections, each with three tracks. Each section will contain atrack for regulated work products. Good laboratory practice, GCP, and GMP define regulated work products. 

Quality Assurance Unit—independence, master schedule, audits, and inspections... 

Control charts are used in many different applications besides analytical measurements. For example, in a manufacturing process, the control limits are often based on product quality. In analytical measurements, the control limits can be established based on the analyst s judgment and the experimental results. A common approach is to use the mean of select measurements as the centerline, and then a multiple of the standard deviation is used to set the control limits. Control charts often plot regularly scheduled analysis of a standard reference material or an audit sample. These are then tracked to see if there is a trend or a systematic deviation from the center-line. 

Audits are conducted as a management tool for assessing the quality level of an operation. They are used to identify nonconformance and to make corrective actions as needed, and prevent reoccurrence of potentiail problems that can adversely affect a product. Audits are conducted internally and externally. Supplier audits may be directed for cause , such as a customer complaint, for change control, or for a product problem. Audits may be scheduled on a regular basis (e.g., every 3 years) for suppliers of key or critical materials. 

Once a laboratory has implemented a quality system in accordance with these requirements, it must make a formal application to UKAS to have its system assessed for the purpose of accreditation and at this stage submits its Quality Manual and its proposed schedule of accreditation for examination, along with any other documentation requested by UKAS. The manual describes the policies and practices through which the laboratory addresses the requirements of the standard. Provided UKAS is reasonably satisfied with the documentation received, and once the laboratory has been advised of any areas needing further attention before assessment, the arrangements for the assessment visit are made. It takes the form of a major assessment/audit... 

Examples of leading indicators include measures of the quality of an audit program, including schedule adherence, the number of repeat injuries, and analysis of process hazard reviews. As with trailing indicators, there must be some type of cause and effect relationship established between leading indicators and safety performance. 

Quality Politics, Quality Objectives, Audit, Verification, Accreditation, Certification, DIN EN ISO 9000, 9001, 9002, 9003, 9004, DIN EN ISO 17025, 17020 and so on. Some of the definitions of the terms are difficult to understand. It is however often only pouring old wine into new wineskins For example, simply saying that for a successful constmction project, a detailed constmction schedule is necessary, which co-ordinates the work of the trades carefully, or that for a standardised test, certain organisational sequences must be adhered to, does not constitute new inventions. Often, in themselves well-known procedures are only formalized and uniformly specified in standards. 

Conformity with the PED requires submission of the technieal file to a notified body who, when satisfied fliat it meets flie essential requirements, issues an EC Type Examination Certifieate fliat entitles the manufacturer to produce copies of the pressure system until the certificate expires. Dining the period of certification, the notified body conducts scheduled and unscheduled annual audits of the manufacturer s quality systems to ensure ongoing compliance. 

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