MICROBIOLOGY QUALITY SYSTEM (MQS)
THE CASE FOR AN INTEGRATED - MICROBIOLOGICAL QUALITY SYSTEMS (MQS) - WHY THE NEED
DFMICRO provides technical advice, support and problem-solving approaches within the client's existing quality management structure. Where client management consider it appropriate DFMICRO can also advise on how best to orientate the quality management resource in a manner that supports Good Microbiological Quality. Solutions derived from this approach referred to as "Microbiological Quality System Management (MQS), are usually more effective and provide longer-term added value.
Microbiology can represent a comparatively small element (investment / resource) of the production/ testing process and consequently its role may be buried within the general Quality Control resource. For most companies "generic" or so called "umbrella" quality standards (ISO, GMP, GLP) form the basis of the QA system approach.
For a variety of reasons (see Common Disablers in Framing Microbiology) one size fits all management systems are better suited to the analysis of relatively stable product characteristics, such as those of chemistry rather than dynamic biological processes common to Microbiology. Given the almost universal usage of Analytical and Bioanalytical techniques within industry, it is no great surprise that the majority of GLP or lab related GMP guidelines are predominantly targeted at these areas of testing. The surprise is rather that Quality management often try to directly employ identical approaches to Microbiology Quality Management with corresponding high levels of deviation and apparent non-compliance.
Good quality practice for Microbiology requires that GMP / GLP requirements, are met in a manner that is justifiable in terms of the science of Microbiology. The nature of Microbiology requires that a suitable MQS create knowledge continuity between the laboratory, production process and environment.
The essential premise of MQS is to ensure that appropriate Microbiological resources (Materials, Methods, Manpower and Management) are strategically positioned at the various key stages of design, development and production, where they can exert the greatest positive influence on overall microbiological quality. Furthermore, MQS endeavours to incorporate the requirements of relevant standards and guidelines in a manner which is both coherent with Good Microbiological Practice and where possible is sensitive to management needs.
MQS Wont Reinvent the Wheel - It just Oils It
Where occasional or once-off microbiological non-conformance occurs, an MQS approach may be an unnecessary and overly detailed approach, but where the efficiency and effectiveness of Microbiological test and quality management programmes consistently fails to meet senior management expectations, MQS can identify how the system can be improved, where the key resources should be positioned and what level of expectation should be reasonably met by the process. An integrated MQS that develops and strategically positions qualified and experienced Microbiologists within the Quality Assurance and Production management structure will provide greater added value to the production process.
"The majority of system failures involving poor Microbiological Quality relate not to inadequate resourcing but to the fact that existing resources have been poorly developed, poorly managed or poorly positioned within the process"
PRINCIPLES OF MQS
1. Personnel Selection:
The suitability (knowledge, qualification, background) of personnel will ultimately determine whether an MQS can work or not. Imposition of personnel with limited microbiology experience in senior, supervisory or junior management positions disrupts, dilutes and retards the coherence and effectiveness of an MQS.
2. Personnel Development:
Contextualised Training programmes for microbiology personnel should place equal emphasis on learning and instruction. The working environment will provide a learning environment and should provide experience. High intensity instructional programmes support compliance while active learning programmes support efficient management and continuous quality improvement. Both elements should be promoted.
The most relevant experience for a qualified Microbiologist working in industry is that gained of the plant environment and the process. In tandem with a suitable scientific background this provides the Microbiologist with the ability to proactively manage all relevant Microbiological aspects of the process and provide added value to the decision making processes.
4. Effective Representation & Communication:
An experienced Microbiologist should always be available to provide instruction, feedback to and communication with senior management when and where considered necessary. Inexperienced Microbiologists and Non-Microbiologists rarely demonstrate the adequate communication skills, background science / process knowledge or confidence necessary to directly support senior management in effective decision-making. In many cases Microbiologists are primarily laboratory-based and are limited to communicating through supervisory or assistant management positions, many of which will have rudimentary knowledge of and or interest in Microbiology.
5. Resource Requirement:
The Times Three principle is a useful rule of thumb when defining resource requirements. Most processes will take three times longer to complete, will require three times as much manpower and will be three times more expensive to complete than anticipated. Resource planning should allow for potential activity peaks associated with adverse quality issues together with, training, calibration, qualification, documentation completion, QA auditing and investigation, cleaning, and Preventative Maintenance requirements. All to often resources are based on routine product test requirements without due consideration of ancillary quality activities that ultimately determine the quality of the test programme.
6. Resource Positioning:
Microbiology resources need to be suitably positioned within the management structure and at the appropriate phase of product and process design and/or development that contributes the greatest positive influence on downstream quality.
7. Corollary of Resource Size:
The smaller the Microbiological Resource considered necessary for a given process, the more critical it becomes that this resource is suitably qualified and experienced.
8. Corollary of Perceived Risk:
The less the risk of microbiological contamination occurring for a specific product / process the greater the likelihood that potentially catastrophic contamination risks exist and will remain unidentified.
Containment and isolation technologies should be reserved to protect the product / environment / personnel from microbial contamination, rather than isolate Microbiologists from contributing to the overall quality of the process.
10. Front End Design / End-User Validation:
New Systems should be adequately evaluated and trialled by the end-users prior to approval and adoption rather than the system owner and or priority stakeholders. In this regard it is considered that the end user of any system is always the principle stakeholder. Where new technologies are to be adopted, all relevant stakeholders, including Microbiology, should suitably evaluate them on a trial basis.
11. Active QA Support:
Compliance benefits accrue where there exists a suitably experienced Microbiological resource within or associated with QA (e.g. QA Liaison) that undertakes an active role in interpreting requirements and developing quality processes / procedures that are supportive, cognisant and user-friendly with respect to the particular characteristics of Microbiological Quality.
12. MQS Integrity:
The integrity of the MQS must be protected. Blanket adoption of generic protocols and procedures is not appropriate. All protocols or procedures that involve any amendment to test, documentation or management practices need at a minimum to be critiqued and stress tested by qualified persons within the Microbiology section prior to adoption. The objective being to avoid the unilateral adoption of practices by other stakeholders that may well be incoherent or incompatible with MQS principles, unit organisation or resource disposition, without suitable prior discussion and planning.
Sampling and samplers serve as the primary cornerstone of Microbiological test programmes. Poor sampling conditions, services or technique will render null and void all downstream test activities. Provision of sampling resources is often considered of low priority within industry and the significance of the function underestimated. Good sampling procedures are reflective of good design principles.
Quality Issues associated with Microbiology rarely if ever originate in the Microbiology Laboratory and are never adequately resolved by routine laboratory testing alone.
15. Test Results:
Individual results are relatively ineffective predictors of Microbiological Quality. Result trends represent more effectively the characteristics of Product / Process quality, yet individual results, both bad and good are respectively lamented or celebrated in equal manner.