Wednesday 22 September 2021

Quality Management Systems


The objectives of a Quality Management System is to:


  • ·         Set direction and meet customers' expectations
  • ·         Improve process control
  • ·         Reduce wastage
  • ·         Lower costs
  • ·         Increase market share
  • ·         Facilitate training
  • ·         Involve staff
  • ·         Raise morale


The basis of a Quality Management System is set out in: ISO/FDIS 9001:2000 — Quality management systems — Requirements.


The adoption of a QMS needs to be a strategic decision of an organisation, and is influenced by varying needs, objectives, the products/services provided, the processes employed and the size and structure of the organisation. A QMS must ensure that the products/services conform to customer needs and expectations, and the objectives of the organisation. Issues to be considered when setting up a QMS include:


Design and build includes the structure of the quality management system, the process and its implementation. It's design must be led by senior managers to suit the needs of the organisation, and this is ideally done using a framework to lead the thinking. Design of the QMS should come from determining the organisation's core processes and well-defined goals and strategies, and be linked to the needs of one or more stakeholders. The process for designing and building the QMS must also be clear, with the quality function playing a key role, but involvement and buy-in to the system must also come from all other functions.

·         Deployment and implementation is best achieved using process packages, where each core process is broken down into sub-processes, and described by a combination of documentation, education, training, tools, systems and metrics. Electronic deployment via Intranets is increasingly being used.

·         Control of the QMS will depend on the size and complexity of the organisation. ISO is a site-based system, and local audits and reviews are essential even if these are supplemented by central reviews.

·         Local control, where possible, is effective, and good practice is found where key stakeholders are documented within the process and where the process owner is allowed to control all of the process. Ideally, process owners/operators are involved in writing procedures.


Measurement is carried out to determine the effectiveness and efficiency of each process towards attaining its objectives. It should include the contribution of the QMS to the organisation's goals; this could be achieved by measuring the following:


  • ·         Policy definition completeness
  • ·         Coverage of business
  • ·         Reflection of policies
  • ·         Deployment
  • ·         Usage
  • ·         Whether staff find the QMS helpful in their work
  • ·         Speed of change of the QMS
  • ·         Relevance of QMS architecture to the job in hand


A form of scorecard deployed through the organisation down to individual objective level can be employed, and the setting of targets at all levels is vital.


Review of the effectiveness, efficiency and capability of a QMS is vital, and the outcome of these reviews should be communicated to all employees. Reviewing and monitoring should be conducted whether or not improvement activities have achieved their expected outcomes.


Improvement should follow as a result of the review process, with the aim of seeking internal best practice. It is part of the overall improvement activities and an integral part of managing change within the organisation.


An effective QMS must ensure that the organisation has a strong Customer Focus. Customer needs and expectations must be determined and converted into product requirements. Top management have to demonstrate Leadership. Providing unity of purpose through an appropriate quality policy, ensuring that measurable objectives are established, and demonstrating that they are fully committed to developing, sustaining and improving the QMS.

Managers must ensure that there is Involvement of People at all levels in the organisation. This includes ensuring that there is an awareness of the importance of meeting customer requirements and responsibilities in doing this, and people are competent, on the basis of appropriate training and experience.


An effective QMS must be a strategic tool designed to deliver business objectives, and must have, at its core, a Process Approach, with each process transforming one or more inputs to create an output of value to the customer. The key business processes may be supported by procedures and work instructions in those cases where it is judged necessary to rigidly define what rules are to be followed when undertaking a task. Most organisations will have core business processes that define those activities that directly add value to the product or service for the external customer, and supporting processes that are required to maintain the effectiveness of the core processes.


The understanding of the many interrelationships between these processes demands that a Systems Approach to management is adopted. The processes must be thoroughly understood and managed so that the most efficient use is made of available resources, to ensure that the needs of all the stakeholders — customers, employees, shareholders and the community — are met.


Customer satisfaction is a constantly moving entity depending on changes in technology and the marketplace, so an effective QMS must be in a state of Continual Improvement. For this to be achieved, attention needs to be given to both the voice of the customer - through complaint analysis, opinion surveys and regular contacts – and the voice of the processes – through measurement, monitoring and analysis of both process and product data. This will result in Factual Decision Making.


Each organisation is itself only a link in the chain of a larger raw material process, and for the long term needs of the community and the organisation there needs to be Mutually Beneficial Supplier Relationships.


Audits, reviews and assessments


A good QMS will not function or improve without adequate audits and reviews. Audits are carried out to ensure that actual methods are adhering to the documented procedures, whilst system reviews should be carried out periodically and systematically, to ensure the system achieves the required effect.


There should be a schedule for carrying out audits, with different activities possibly requiring different frequencies. An audit should not be conducted just with the aim of revealing defects or irregularities – they are for establishing the facts rather than finding faults. Audits do indicate necessary improvement and corrective actions, but must also determine if processes are effective and that responsibilities have been correctly assigned. The emphasis on process improvement and enhancing customer satisfaction in the revised standard will require a more thoughtful approach to auditing.


The generic steps involved in an audit are:


·         Initiation

  • ·         Scope
  • ·         Frequency
  • ·         Preparation
  • ·         Review of documentation
  • ·         The programme
  • ·         Working documents
  • ·         Execution
  • ·         Opening meeting
  • ·         Examination and evaluation
  • ·         Collecting evidence
  • ·         Observations
  • ·         Close the meeting with the auditee
  • ·         Report
  • ·         Preparation
  • ·         Content
  • ·         Distribution
  • ·         Completion
  • ·         Report
  • ·         Submission
  • ·         Retention


A quality management system review should take place, possibly once a year, which should cover:


  • ·         Results of audits
  • ·         Customer feedback
  • ·         Process and product conformity
  • ·         Status of preventative and corrective actions
  • ·         Follow up actions from previous management reviews
  • ·         Changes that could effect the QMS
  • ·         Recommendations for improvements
  • ·         Outputs should include:
  • ·         Improvements to the QMS and processes
  • ·         Improvements of a product related to customer requirements
  • ·         Resource needs


In addition, the procedures for conducting audits and reviews and the results from them should be documented, and also be subject to review. Internal system audits and reviews should be positive and conducted as part of the preventative strategy, and not as a matter of expediency resulting from problems. The assessment of a quality system against a standard or set of requirements by internal audit and review is known as a first-party assessment or approval scheme. If an external customer makes the assessment of a supplier, against either its own, or a national or international, standard, a second-party scheme is in operation. The assessment by an independent organisation, not connected with any contract between the customer and supplier, but acceptable to them both, is an independent third-party assessment scheme.


All managers, not just the staff in the "quality department", need to be fully committed to operating an effective quality management system for all the people within the organisation. The system must be planned to be effective and achieve its objectives in an uncomplicated way. It should also not be static, but be flexible, to enable constant seeking of improvements.


Quality Management Review


The object of the Quality Management Review is to provide an overview of the results from the Quality Control and Quality Assurance functions. The review forms part of an organization's Quality Management Systems (as detailed in ISO 9001). The issues covered will vary between different workplaces. However, issues often included issues are results of audits; discussions of follow up items; a review of progress relating to non-compliances and discussions relating to the effectiveness of corrective and preventative action; test and sampling efficiency times; customer complaints; rejects; out of specification results from test data; microbiological contamination issues and trends in relation to processing of product and to the manufacturing environment. Issues of major concern are often considered using risk management techniques.


Data is presented by participants from different departments. The data is normally measured against a target (to allow for effectiveness, efficiency and capability to be measured). This can be relatively straightforward, such as the number of internal audits completed against a target level (such as 95% of audits to be completed to schedule) or more complex when relating to statistical process control charts for laboratory test data.


Participants will include representatives of laboratories, production, process, pharmacy and ward management. Meetings are held either monthly, quarterly or annually (at my workplace, the meetings are held quarterly).


Where problems or upward trends are identified the aim of the meeting is to identify the risk, assign a priority, to agree actions and to track progress. For issues that cannot be satisfactorily dealt with these are referred to senior management. Quality Management Review meetings may sometimes elect to form subgroups to examine specific areas, such as sampling; new processes technologies and so on.


It is important that the outcomes of the Quality Management Review are communicated to all members of staff.


Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (

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