Auditing standard work

For laboratories seeking external accreditation of their work, audits must be planned and written down so that the laboratory can show that they are being carried out. You should note that a laboratory will not be criticized for finding problems when they audit their work. The important thing is to be on the lookout for problems, to find them where they exist and to put them right. No laboratory should rely solely on periodic assessments by an external body to ensure that standards of quality are continuously maintained. There are a number of reasons for this. 

Audit the work against agreed plan and standards. 

In the first session of the FDA work group, it became obvious that the industry that has to fulfill these requirements had no common understanding about what is really necessary, what is helpful and when is it more than expected. As a spin-off initiative, six companies came together to define an audit group. They established a common audit standard for their companies and performed two Supplier Audits as joint audits. This group is now developing a common validation strategy to validate SAP installations in their companies. 

Standard work can be the audit step that ensures success of any large-scale change effort. 

A safety and health audit of the work being done to control loss measures the safety system and highlights its strengths and weaknesses. The audit compares work being done, and standards being maintained, with accepted safety and health standards. It can be used to review and evaluate the performance and effectiveness of the safety system, and also to establish whether or not it meets international safety management system standards. 

If the specific audits are conducted by a team organized by corporate, the company should provide audit standards and work processes that describe assessment topics and the requirements for conducting assessments, reporting, and documentation. 

As a supervisor or leader, you need to ensure that the audits conducted in your area are effective and of a consistent standard. When we properly train our people (both hourly and management) to audit, and work with them to increase their awareness of what auditing is all about, we raise the standard of audits in our area and provide a safe, clean, hazard-free, productive work environment. 

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 standard requires that trained personnel be assigned for management, performance of work, and verification activities including internal quality audits. 

The reason for an Exposition is so that there is a description of the system showing how it works and how it controls the achievement of quality. This is different from the policies and procedures. The policies are a guide to action and decision and as such are prescriptive. The procedures are the methods to be used to carry out certain tasks and as such are task related. They need to be relatively simple and concise. A car maintenance manual, for example, tells you how to maintain the car but not how the car works. Some requirements, such as those on traceability and identification, cannot be implemented by specific procedures although you can have specific policies covering such topics. There is no sequence of tasks you can perform to achieve traceability and identification. These requirements tend to be implemented as elements of many procedures which when taken as a whole achieve the traceability and identification requirements. In order that you can demonstrate achievement of such requirements and educate your staff, a description of the system rather than a separate procedure would be an advantage. The Exposition can be structured around the requirements of ISO/TS 16949 and other governing standards. It is a guide or reference document and not auditable. 

The document availability requirement applies to both internal and external documents alike. Customer documents such as contracts, drawings, specifications, and standards need to be available to those who need them to execute their responsibilities. Often these documents are only held in paper form and therefore distribution lists will be needed to control their location. If documents in the public domain are required, they only need be available when required for use and need not be available from the moment they are specified in a specification or procedure. You should only have to produce such documents when they are needed for the work being undertaken at the time of the audit. However, you would need to demonstrate that you could obtain timely access when needed. If you provide a lending service to users of copyrighted documents, you would need a register indicating to whom they were loaned so that you can retrieve them when needed by others. 

Audits of practice against procedure or policy should be recorded as they are observed and you can either do this in note form to be written up later or directly onto observation forms especially designed for the purpose. Some auditors prefer to fill in the forms after the audit and others during the audit. The weakness with the former approach is that there may be some dispute as to the facts if presented some time later. It is therefore safer to get the auditee s endorsement to the facts at the time they are observed. In other types of audits there may not be an auditee present. Audits of procedure against policy can be carried out at a desk. You can check whether the documents of the quality system satisfy all the clauses of the standard at a desk without walking around the site, but you can t check whether the system is documented unless you examine the operations in practice. There may be many activities which make the system work that are not documented. 

These checklists may be used to indicate compliance with standard procedures. As indicated above, a checklist is easy to use and can be applied to each stage of a project of plant development. A checklist is a convenient means of communicating die minimal acceptable level of liazard evaluadon diat is required for any Job, regardless of scope. As such, it is particularly useful for an inexperienced engineer to work tlirougli die various requirements in the checklist to reach a satisfactory conclusion. However, a system checklist should be audited and updated regularly. 

During an audit, a failure to comply with any component of the relevant Standard(s) is recorded as nonconforming work or observations. There are a... 

The major category of nonconforming work is allocated for any failure of a system to comply with the requirements of the Standard which could lead to invalidity of test results. Examples include absence/non-implementation of a document control system, absence/non-implementation of a procedure for internal audit or management review, staff not technically competent to perform particular tests and failure to control the quality of test data. 

This chapter describes how a laboratory manages the quality of its work. In Chapter 2, an indication was given of the Standards a laboratory might select. This chapter compares and contrasts such Standards and sets out how a laboratory chooses the most appropriate Standard to demonstrate the quality of their work. Many components make up a management system and each one of them is described, including the purpose and conduct of audits, internal and external. Examples are given of some of the documentation required. 

For example For contract work an anditor comes to the laboratory and checks whether the staff perform the task according to (agreed) standards, utilising appropriate laboratory equipment correctly. This is also called assessment or external audit. Internal auditors can be colleagues (from a different laboratory in the same company or a different working area). Reviews are usually carried out by upper level managers. 

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. 

Traditionally, the education that chemists and chemistry laboratory technicians receive in colleges and universities does not prepare them adequately for some important aspects of the real world of work in their chosen field. Today s industrial laboratory analyst is deeply involved with such job issues as quality control, quality assurance, ISO 9000, standard operating procedures, calibration, standard reference materials, statistical control, control charts, proficiency testing, validation, system suitability, chain of custody, good laboratory practices, protocol, and audits. Yet, most of these terms are foreign to the college graduate and the new employee. 

The GLP standards can be successfully implemented in a non-GLP anal5dical laboratory. The key to success is for management and staff to fully understand the ramifications of the decision and to set in motion a plan to achieve compliance. The plan should include a time line, assignment of responsibilities, and self-audits. The outcome wiU be an improvement in the overall quahty of the anal5dical work produced by the lab and the abUity to participate in a specialized analytical market niche. 

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