Lesson 2 - Quality Assurance and Quality Management
This lesson looks at the management of quality both generally and in the brewery. It discusses definitions of quality and then explains and compares approaches to quality control and quality assurance. Next, it details the components of a formal quality management system as well as tools used in quality management. Finally, it explains what tools are available for the systematic management of food safety and product integrity, and considers how these apply in the brewing industry.
ISO 9000 Standards
Many breweries will have the ISO 9000 standard as the basis of their QMS so we will now explore the important elements of this key standard.
ISO is the short name given to the International Organisation for Standardisation. ISO is a worldwide federation of national standards bodies from over 160 countries. The mission of ISO is to promote the development of standardisation and related activities in the world, so as to facilitate the international exchange of goods and services. In essence, ISO gets all nations speaking the same commercial language. As the quality of products is key to effective trade, ISO developed ISO 9000 to be the global ‘language’ of quality.
ISO 9000 is not a QMS in itself. Instead it provides standards which guide a business through the implementation of a structured QMS which can be audited by an accreditation body to achieve certification. There are a number of ISO 9000 standards but the essential components of a QMS are:
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ISO 9001:2015 – the requirements of the quality management system.
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ISO 9000:2015 – setting out the basic concept and language.
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ISO 9004:2018 – the means to ensure you have an effective QMS.
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ISO 19011:2018 – providing guidance on internal and external audits of QMSs.
The ISO systems are based on the following quality management principles:
Principle 1 – Customer focus
The understanding of customer needs and the ability to meet those needs.
Principle 2 – Leadership
Leaders of the business are champions of quality management and act to ensure it is a common purpose throughout the organisation.
Principle 3 – Engagement of people
Everyone within the organisation understands what the business wants to do in terms of quality and is energised to contribute to it.
Principle 4 – Process approach
Efforts and resources are coordinated into a process to achieve quality objectives.
Principle 5 – Improvement
The business seeks to improve continuously as a permanent goal.
Principle 6 – Evidence-based decision making
Business decisions are driven by data and evidence.
Principle 7 – Relationship management
The organisation is involved in mutually beneficial relationships with its supply chain.
ISO 9001:2015 (requirements of the quality management system) is organised into clauses which are based on the PDCA cycle that we encountered earlier.
1. Scope
2. Normative references
3. Terms and definitions
These three clauses set out the scope of the standard, define the terms used, and list important documents. The next seven deal with the system itself and constitute the mandatory elements.
4. Context of the organisation
5. Leadership
6. Planning
7. Support
8. Operation
9. Performance evaluation
10. Improvement
To ensure they are relevant and current, ISO standards are updated at least every five years.
The amount of documentation and management time required to operate a formal QMS is very large. In all but the smallest breweries, there will be a manager appointed to oversee the system, and a large brewery will have a whole department. A software system to manage documentation and quality data is also a practical, if not essential, requirement. Every action in production will need to be defined, measured, and recorded which can make it seem less enjoyable.
The formal QMS provides a kind of badge of quality for potential customers and provides the following commercial benefits:
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Improvement of the credibility and image of the business
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Increased access to market and competitiveness
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Improved efficiency through a reduction in quality failure
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Easier compliance with food safety regulations
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Simpler integration with health and safety, food safety, integrity, and environmental systems and standards – ISO 14001 for example
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Improvement of organisation-wide quality awareness
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Reduced workload in management of quality with changes in management/ownership
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Better long-term supplier–customer relationships
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Continuous improvement in quality
You should now have a good understanding of the principles, components, requirements, and benefits of systematic management of quality. Next, we will consider other tools at our disposal for improving the quality of what we make and how we make it.