General Quality Management Systems Program
This 10-week training program provides a comprehensive overview of the fundamental principles of quality management systems – whatever the industry or quality standard.
Quicklinks
Course overview
There are 10 modules in this program, with a new module delivered each week. The program is designed to build on the knowledge and skills of the previous week’s learning.
- Risk Management
- Organisational Structure & Training
- Audits, Auditors & Auditing
- Corrective & Preventive Action (CAPA)
- Quality System Documentation
- Data Integrity
- Facilities & Equipment
- Computerised Systems & IT Infrastructure
- Retention of Records & Materials
- Business Continuity & Disaster Recovery
Each module is covered in a 2.5-hour training session.
Delivery streams
This program has two delivery streams to choose from:
- DAY CLASS: 12.00 – 2.30 pm AEST
- NIGHT CLASS: 7.00 – 9.30 pm AEST
Who should attend this course?
This program is ideal for anyone who has an interest in quality management systems – and is particularly valuable for the following people / groups / organisations, from all industries:
- New Employees – who need to understand fundamental quality management system concepts to be set up for success in their new role.
- Existing Staff – who need to stay up to date with current quality expectations to operate effectively within the existing quality management system.
- New Graduates – who would like a competitive advantage at the commencement of their careers, and to translate quality theory from university into quality management practice in the laboratory context.
- Quality Leaders – who are responsible for safeguarding, managing and improving quality in the organisation, and who need to lead others to participate fully in a quality culture.
- Potential Accredited Facilities – organisations considering implementing a quality management system to become accredited.
- Quality-Focused Facilities – organisations wanting to improve their quality, without becoming accredited.
Delivery
This program is delivered virtually using the Zoom platform, with a maximum of 16 participants to ensure a genuinely personalised learning experience. Weekly sessions are designed to maximise learning through the following format:
- The first hour introduces the module topic in an engaging, interactive way.
- The second hour is a workshop where participants apply their new knowledge to a series of entertaining, team-based activities with clearly defined learning objectives. Throughout this process, participants acquire practical tools and materials they can immediately use within their own environment.
- The final 30 minutes features a fun, multiple-choice quiz to identify any areas that require further discussion or review. This leads directly into a Q&A session to ensure maximum value for individual participant needs and learning styles.
- At the end of the session, participants are provided with ‘follow-up exercises / practice activities’ to be completed by the following week. These help clarify any learning gaps and apply what has been learned during training in a practical and realistic context.
Although participants are strongly encouraged to attend every session ‘live’, if a participant is unable to attend their designated session, a recording and all associated materials will be made available through the online learning portal.
What you will learn per week
| Week 1 Risk Management | In this opening module, we introduce the concept of ‘risk management’. This best-practice approach encourages development of a Quality Management System (QMS) that is specifically designed to maximise the effectiveness and efficiency of each unique workplace environment. We look at how to identify, analyse, evaluate and treat risks, and the importance of establishing a risk monitoring program that ensures the effectiveness of any actions taken, and detects any new or emerging risks. All subsequent program modules draw on the principles of risk management introduced in this first week. |
| Week 2 Organisational Structure & Training | This module takes us into the world of organisational structure, training and training records – critical parts of every QMS given the benefits of having qualified staff performing activities and regulatory requirements for documenting the training process. We start with a broad lens, looking at organisational structure, and then progressively zoom in towards position descriptions, job roles and the competencies associated with a specific job role. We identify the power of a simple training matrix and provide an overarching approach to training records retained in an electronic or paper-based system. |
| Week 3 Audits, Auditors & Auditing | Next, we take a detailed look at audits, auditors and auditing – an important role / process within any QMS as it provides an objective assessment of whether the organisation’s performance and documentation conform to any applicable standards (both internal and external to the organisation). We begin by outlining different types and formats of audits before shifting to the characteristics / skill sets of a good auditor. We then focus on the audit process itself, from developing an audit program (using a risk-based approach) through to the planning, preparation, conduct, follow-up and closing-out of an audit. |
| Week 4 Corrective and Preventative Actions | This module examines how we handle issues / problems that may have been identified by the management system, with a view to ensuring they do not reoccur – a key premise of every QMS. We look at the various ways in which these issues / problems are detected (e.g. through audits and risk assessment) and then assess their impact alongside their containment and correction. We then look at various approaches to root cause analysis and the subsequent development and implementation of appropriate corrective / preventive action. We also review the different ways we can verify the effectiveness of those actions. |
| Week 5 Quality System Documentation | Our journey continues with Quality System Documentation (QSD) – perhaps the most ‘widely known’ component of a typical QMS. From promoting consistency in processes and output, to minimising potential errors and avoiding knowledge loss, QSD provides the framework for every QMS. We look at the QSD lifecycle as we prepare, approve and distribute documentation, how we ensure our QSD remains current and, importantly, how an external reviewer can understand the procedure being followed at any point in the past. We also learn about the typical structure and format of Standard Operating Procedures (SOPs), using real-life examples. |
| Week 6 Data Integrity | As the transition from paper-based systems to electronic systems gathers pace, the continuously evolving nature of data integrity has been at the forefront of QMS considerations in recent years. This includes concepts such as metadata, readability and back compatibility. We reflect on the ‘data lifecycle’ and the associated implications of ALCOA+, use risk management skills to assess high-level data integrity risks, within unique environments, and consider appropriate risk mitigation strategies. |
| Week 7 Facilities & Equipment | Equipment lies at the heart of the work undertaken by many organisations and has a critical role in the generation of reliable data. In this module, we review the expectations of a QMS with regards to equipment, from initial receipt through to appropriate ongoing calibration / performance checks and preventive maintenance. Concepts such as metrological traceability and measurement uncertainty are explored and the importance of well-maintained equipment records is considered. |
| Week 8 Computerised Systems & IT Infrastructure | Computerised systems, which comprise a function (process or operation) controlled by a computer system, provide us with a range of new challenges and these are explored throughout this module. Through the concept of the validation lifecycle, we explore the critical steps before and after its release into a ‘production environment’. This includes a diverse range of items such as user requirement specifications, vendor audits, risk assessment, validation plans, qualification (IQ, OQ, PQ) all the way through to change control, periodic review and retirement. We also consider IT infrastructure as part of this module. |
| Week 9 Retention of Records & Materials | In this module we look at the importance of effective archiving within every QMS i.e. the process of protecting records from the ability to be further altered or deleted throughout the required retention period. We will look at different record categories (e.g. study / project records, facility records) and the formats (e.g. hard copy, electronic). We focus on the processes associated with initially archiving these records and the action required for retrieval. We also investigate the advantages and disadvantages associated with the use of commercial off-site archives. |
| Week 10 Business Continuity & Disaster Recovery | In our final module we ensure we have well-established business continuity and disaster recovery plans. This is a critical aspect of any QMS as it can significantly minimise the impact of adverse events. Using what we have learned in previous modules, we identify risks, plan appropriate responses and define roles and responsibilities. We then look at the importance of testing our responses to ensure they are genuinely effective and not just a theoretical response. As with all aspects of a QMS, we explore how our approach to business continuity and disaster recovery is continuously evolving for it to remain effective. |
