Unit 7 Flashcards
3 definitions of quality
1 - as fit for purpose
2- as customer satisfaction
3 - as conforming to specification
Overall definition of quality
Conformance to specification which incorporate customer wants and needs, as well as legislation. Produces consistent product and customer satisfaction
2 aspects of quality management
Quality control & Quality assurance
Define quality control
Inspect/sample product against specification and take corrective action if it does not meet specification. Usually performed before progression to the next ‘stage’ of production.
Define quality assurance
Develop and implement systems which prevent the product from becoming inadequate. Real time measurements of key process control conditions.
Definition of Total Quality Management
Management approach of an organisation centred on quality, based on participation of all members and long term success and customer satisfaction
12 principles of Total Quality Management
- Quality can and must be managed.
- Everyone is a supplier with a customer.
- Processes, not people, are the problem.
- Every employee is responsible for quality.
- Problems must be prevented, not just fixed.
- Quality must be measured.
- Quality improvements must be continuous.
- The quality standard is defect free.
- Goals are based on requirements, not negotiated.
- Life-cycle costs, not front end costs.
- Management must be involved and lead.
- Plan and organise for quality improvement.
Quality control examples
Testing spirit ABV once produced.
Sensory assessment of spirit once produced
Quality assurance examples
Monitoring of distillation temperature and pressure.
Monitoring of spirit ABV during distillation.
Energy and wash feed to stills.
Differences between quality control and assurance
Assurance is proactive, control is reactive.
Assurance is on-going throughout production, control is one-off, pass/fail.
Control is about measurement and inspection of products (product orientated), while assurance is is about demonstrating confidence in processes and products, as well as their improvement (process orientated.)
Assurance - everyone responsible, QC team responsible for control.
Assurance prevents problems, while control identifies and removes problems when they occur.
Theory behind quality assurance
Changes can be made to chosen process conditions to ensure the product is within specification.
2 main principles of quality assurance
Fit for purpose
Right first time
6 steps of the quality assurance process
1 - define the requirements and responsibilities related to all areas of production
2 - define the product requirements.
3- Define all materials, packaging, technologies, and storage techniques required, as well as the number and qualification of people.
4- analyses sources of faults and factors affecting quality
5 - Define the quality assurance actions, information, education, training, motivation, investigation parameters, methods of analysis, and sampling documents.
6 - Define responsibilities for certain quality reassurance actions.
Simplified steps of quality assurance process
1- Defining what needs to be managed.
2 - Quantifying it
3 - Assembling the capability to measure and manage it.
4 - Allocating responsibility for measurement and managing.
What is PDCA?
Cycle of quality assurance
Plan - Do - Check - Act
AKA - the Demming Wheel
Nine elements of a formal quality management system
1- Quality objectives
2- Quality manual (policies, structures, procedures, responsibilities)
3- Organisational structure and responsibilities.
4- Data management
5- Internal process management (audits, etc)
6- Product quality leading to customer satisfaction.
7- Continuous improvement (inc corrective and preventative actions)
8- Analysis of key quality attributes
9- Document control
QMS document structure
Policy - defines what will be done
Procedures - By who, and to what standard
SOPs - How
Records - Proof/Evidence
ACT components of a Deming Wheel focussed QMS
Management Responsibility Process
-Manage commitment and customer focus
-Quality policy and objectives
-QMS
-Quality plans
PLAN components of a Deming Wheel focussed QMS
Resource Management Process
-HR
-Training
-Competences
-Communications
-People infrastructure
-Work environment
DO components of a Deming Wheel focussed QMS
Product Realisation Process
-Product design
-Supplier management
-Operations planning and control.
-Manufacturing processes
CHECK components of a Deming Wheel focussed QMS
Measurement, Analysis, and Improvement Process
- Customer satisfaction
- Monitoring processes
- Internal audits
- Management reviews
- Improvement processes
- Control of non-conforming material.
What does ISO stand for?
International Organisation for Standardisation
Commercial benefits of a formal QMS
- Credibility and business image.
- market access and competitiveness.
- Efficiency (reduction in product quality failure)
- Easier compliance with regulations.
- Simpler integration of other standards (H&S, food hygiene, integrity, environmental)
- Improvement of organisation wide quality awareness.
- Reduced workload in QM with leadership changes (consistency)
- Better long-term supplier/customer relationships.
- Continuous quality improvement.
Essential components of an ISO9000 QMS
ISO 9001:2015 - requirements of the QMS.
ISO 9000:2015 - Setting out basic concept and language.
ISO 9004:2009 - means to ensure you have efficient and effective QMS
ISO 19011:2011 - Providing guidance on internal and external audits of QMSs.