The purpose of the quality assurance program is to assure that all laboratory testing is performed according to the principles of current Good Laboratory Practice (cGLP). This is carried out by the quality assurance department which has the authority to authorise all quality related documentation. The quality assurance department is staffed by individuals who are knowledgeable of, and familiar with, the laboratory testing.

It is a fundamental cGLP principle that those individuals who carry out the quality assurance program must not be involved with the laboratory testing being assured and are also entirely independent of the laboratory management and free of any influence or pressures that may influence the performance of their duties.

The quality assurance department achieves its objectives by:

• Establishing standard operating procedures (SOPs) for all stages of the laboratory testing, from managing incoming samples to authorising study reports and test certificates for the client
• Monitoring compliance with SOPs and mandating administrative requirements, such as record keeping, data evaluation and performing internal audits
• Investigating deviation and non-compliance, and specifying corrective actions and assigning responsibilities for their implementation
• Maintaining a high level of staff involvement

It is fundamental that the quality assurance program covers all aspects of the laboratory’s operations. One way of achieving this is to align your quality assurance program with the functions that need to be performed in order for the laboratory to achieve its objectives in a compliant manner.

Related: Learn More About GLP

Some examples of these are listed in the table below which are based on the principles of current Good Laboratory Practice (cGLP).

Some Typical Laboratory Quality Functions

It should be noted the quality systems described here is an example only, and there are many equally valid systems that could be used. Each laboratory should establish the most appropriate program to meet its requirements. You will certainly find that your laboratory’s QAP will evolve over time as the needs of the laboratory change and new regulatory requirements and expectations emerge.

Structure of the Quality Assurance Program

The structure of a quality assurance program refers to the way the various documents, such as quality policy statements, conformance standards and standard operating procedures, that control and document the program are organised for ease of reference and for day to day operation.

It should be noted that the structure described here is most suitable for medium to large laboratories, with several operating departments and possibly consisting of sub-departments. For smaller laboratories it may be preferable to combine the policy and conformance standard in to a single document.

Quality Systems

A quality assurance program can be logically divided into a number of separate but interdependent quality systems dealing with specific functions of the overall quality assurance program, such as those listed in table 3.

Adopting this system based approach provides a logical degree of structure which will:

• Facilitate its use by making the system easier to understand
• Be easier to update and control
• Facilitate both regulatory and client audits as system based auditing is now employed by most regulatory agencies and many clients

The individual quality systems comprise of and are controlled by a series of standalone documents which fall into three categories and form a hierarchal system illustrated in Figure 1, which is a schematic diagram of the structure of a typical quality assurance program.

The overall quality assurance system consists of a top level quality mission statement, which states, in a few lines, what the laboratory is setting out to achieve and serves as a focal point for the entire quality assurance program.

A suitable quality mission statement might be:

“ABC Laboratories supports its clients’ businesses by providing accurate and precise, high quality, scientifically and legally defendable analytical data in a timely and cost effective manner while meeting all regulatory requirements”.

The various documents which control the quality assurance program can be grouped into three separate hierarchal levels.

These in descending order of precedence are:

• Top level quality policies
• Intermediate level conformance standards
• Operational level documents such as standard operating procedures

This is an extract taken from An Easy to Understand Guide to Current Good Laboratory Practices (cGLP).