Version 1.6.1
David Trew
Consulting Ltd
Quality Management Systems for Analytical Laboratories
The business function of an analytical laboratory is to receive analytical samples, perform chemical, microbiological, physical or electronic analysis and deliver high quality, reliable and trustworthy results to the client or customer. To be able to achieve this in a consistent manner requires the laboratory to establish and maintain a suitable quality management system (QMS). The purpose of a QMS is to prevent situations arising that could compromise the quality and integrity of the scientific data the laboratory produces. This can be achieved by establishing documented policies, standards and procedures which are designed to ensure that all activities carried out in the laboratory are performed in a consistent way by all members of staff, and with due consideration for the quality and integrity of the results that are delivered to the client.
Documenting the laboratory’s quality policies, standards and procedures provides:
- A mechanism for defining the quality management system that will provide a consistent and secure means of monitoring the system
- A means of communicating their respective responsibilities and the procedures to be followed to all members of staff
For a quality management system to be effective and able to constituently serve its purpose, the documented policies, standards and procedures must be organised in as to facilitate its easy use by all members of staff in their everyday work. It is therefore important that QMS documentation is organised in a structured, logical and easy to understand way. In addition, all quality documents must be under a state of control to prevent out of date or unapproved versions from being used for laboratory work.
This article describes one such way of structuring the organisation of the documentation that defines the quality management system of a typical analytical laboratory.
1 Document levels
I advocate a system consisting of a hierarchy of four levels of documents as follows:
Level 1 Quality Mission Statement – This states the laboratory’s intention and goals regarding the quality of the services it provides. The Quality Mission Statement should include management commitment to:
- The quality of the work of the laboratory and to its continuous improvement
- The results and scientific data the laboratory produces will be fit for purpose and will withstand scientific and technical scrutiny as well as being delivered in a timely manner and meeting the budgetary commitments agreed with the client
- Providing adequate resources to perform the work in a timely manner and operate the quality management system
- Including all staff in ensuring the laboratory’s work conforms to the requirements of the quality system, in addition to complying with all regulatory, safety and legal requirements
Level 2 Quality Policies – These documents establish the laboratory’s polices regarding specific aspect(s) of the laboratory’s operations.
Level 3 Quality Standards – These documents describe the systems and procedures that will be established to achieve compliance the quality policies.
Level 4 Working Documents – These documents describe how a specific activity that affects the laboratory’s services will be carried out. These are typically known as standard operating procedures (SOP), analytical methods and protocols.
2 Quality Systems (QS)
A laboratory’s operations can be broken down into a number of different functions, such as:
1. Quality Assurance
2. Laboratory Management
3. Laboratory Instrumentation
4. Laboratory Investigations and Control of Non-
5. Laboratory Records and Documentation
6. Validation
7. Maintenance
8. Calibration
The tasks that are performed within these Quality Systems need to be controlled by policies and procedures to ensure they are carried out in a consistent and compliant manner. A quality system is a convent way grouping the document associated with a particular laboratory operation.
3 The Relationship Between Documentation Levels and Quality Systems (QS)
Each Quality System will need to have a number of different documents associated with it. Let’s take a look at the Quality System for controlling laboratory instrumentation as an example. These QS will have associated policies quality standards and working documents such as SOPs and protocols.
3.1 Level 2 Documents, Policies
The policies for laboratory instruments should reflect the requirements of the regulations or Standard (e.g. current Good Manufacturing Practice, current Good Laboratory Practice and ISO 17025) the laboratory is operating to. Therefore the policies associated with the Laboratory Instrument Quality System might read:
1. All laboratory instruments shall only be used in such a manner conducive with delivering accurate and precise results.
2. All laboratory instruments shall be demonstrably suitable for their intended purpose and shall operate within documented predetermined and approved criteria.
3. All laboratory instruments shall be maintained, serviced and calibrated at appropriate intervals according to a documented preapproved schedule.
4. The quality, compliance and business risks associated with a failure of a function(s) of the laboratory’s instruments shall be assessed at appropriate times, and controls and procedures shall be established to mitigate those risks.
5. Any laboratory instrument that does not perform with its predetermined criteria, or presents an unacceptable quality, compliance or business risk shall not be used.
3.2 Level 3 Documents, Quality Standards
The purpose of the level three documents (Quality Standards) is to identify the working systems and procedures required to comply with the policies. Therefore the Quality Standards for laboratory instruments might read:
1. Each laboratory instrument or type of laboratory instruments shall have a written and approved standard operating procedure which
Establishes responsibilities associated with the instrument
Provides sufficient directions for the operation of the respective instruments, in sufficient detail to assure that the instrument can be operated in a consistent manner
Provides directions for any precautions that should be taken to assure the accuracy and precision of the results or information delivered and the safety of the operator
Establish a servicing, maintenance and calibration interval
2. There shall be a standard operating procedure providing directions of the activities to be undertaken when procuring and commissioning new laboratory instruments, in order to provide documented evidence that that all laboratory instruments:
- Have the required functionality
- Are delivered according to the purchase order and are undamaged on delivery
- Have been correctly installed according to the needs of the business and in accordance with the manufacturers recommendations
- Operate according to establish manufacturers recommendations
- Perform to criteria appropriate to its routine use
- All systems to assure the quality and reliability of the results delivered have been correctly established
3. There shall be standard operating procedures describing the activities that shall be carried out and the documents that shall be created to assure that all laboratory instruments are serviced, maintained and calibrated at appropriate intervals.
4. A master qualification plan shall be established which shall:
- Define the laboratory’s qualification requirements, philosophy and strategy
- Identify each laboratory instrument
- Establish a schedule and a system for tracking for servicing, maintenance and calibration activities
5. There shall be a standard operating procedure(s) describing the activities to be carried out and the documentation required to assess the quality, compliance and business risks with a functional failure with all laboratory instruments.
6. There shall be a standard operating procedure(s) describing the activities to be carried out and the documentation required when decommissioning laboratory instruments.
3.3 Level 4 Documents, Working Documents
The working documents are the standard operating procedure, protocols and analytical methods used in the day to day work of the laboratory. A standard operating procedure for the operation of analytical balances would contain
An Assignment of the responsibility to assure the balances are serviced, maintained and calibrated by their due dates.
Directions for daily checks to assuring the correct operation of the balance and the associated documentation.
Directions concerning housekeeping
Acceptable weighing practices
Actions to be taken if the balance requires repair
The interval for servicing, maintenance and calibration
4 Document References
Each quality document should be allocated to one of the Quality Systems and all documents should be identified with a unique document reference. In the system described in this article each document should be identified using the following format:
Document Type, Quality System Number, Document Number, Version Number
Where:
Document Type: is the type of document such as Policy, Quality Standard or SOP etc.
Quality System Number: refers to the quality system to which the document has been allocated
Document Number: references the specific document within the respective quality system
Version Number: is the sequential version number of the document to be issued
For example SOP.3.101 v3.0 is version 3.0 of the one hundred and first SOP to be issued in the Instrumentation Management quality System.
5 Conclusion
The quality documents that define and specify your quality management system and describe the procedures that encompass it are critical to the effective management of quality in your laboratory. During an audit the inspectors will assess your laboratories level of compliance by reference to, and comparison with your documented policies, standards and procedures.
To be able to work in an efficient, yet compliant manner, your staff needs to be able to access the relevant procedures quickly and easily. In other words they must understand where to locate the relevant documents. A laboratory quality management system may contain many hundreds of documents, and in order for any particular document to be located in an efficient manner requires logical organisation of those.
When documents are not organised in a logical easy to access manner, staff may take short cuts, such as retaining uncontrolled copies of documents, for easy reference, with the attendant risks of using out of date procedures in their everyday work.
Establishing the most effective quality management system for your laboratory is a significant activity that requires considerable experience in order to appreciate the significance of all the regulations, requirements and expectations. With over twenty five years of experience of working in both academic and industrial laboratories, including fifteen years of experience of working in the pharmaceutical industry, I can help you establish to most suitable quality management system for your laboratory.