Unit 14 Quality Assurance & Management Flashcards
What are the key features of a Quality Management system?
- To understand precisely what is to be achieved. This means having specifications & procedures and everything to be documented.
-To monitor actual performance against what is to be achieved. This means keeping records or performance and also auditing.
- To correct things when they go wrong. This means having a system initiating corrective action.
- To review the overall quality management system and to plan for improvement.
What should specifications detail?
all parameters that are required to be measured, including flavour and nose and must identify an ideal value together with an acceptable range for each parameter.
Describe procedures.
They are there to explain what has to be done and when and how it should be done. Procedures can cover a wide range of topics:
-Explanation of the organisation & responsivities
-Procedures to be followed in the case of non conformance’s
-Procedures on how the processes are managed
-Instructions on how to operate the plant to achieve the procedure consistently
-Procedures to be follower when auditing
Why do quality management systems rely on documents?
To ensure that procedures are being followed. “If it isnt written down it isn’t done”
Many spirit packers also use electronic means for storing documents and maintaining procedures to ensure that the current version of a procedure is being used in all relevant places.
Documents are “controlled” so people are confident that the document they are working to is current and valid.
what is the purpose of auditing?
To check that the quality system is being followed.
Audits are concluded with a report back which normally identifies areas or improvement.
What would a procedure include to put things right?
-Detail of the problem
- Nominating the person responsible for taking the action
-When the corrective action will be completed
- A review of the result of the corrective action taken
Why is a review required?
So it can be confirmed that for example:
- corrective actions are being followed (implemented) in time.
-Audits are taking place as specified
- The packaging plants quality is meeting requirements
What are the advantages over a “Final Inspection” approach?
- The use of documented procedures & specification ensures that everyone knows what they are supposed to be doing.
- The responsibility for quality sits with the people who are operating the plant and manufacturing the product.
-Quality problems will be identified as soon as they occur rather than much later when the process is over.
- Maintenance of accurate records makes it easier to track back and investigate raw materials or processes so that “ due diligence” in manufacturing can be proved.
What are examples of Typical Quality Management Systems Include?
ISO 9000 - Quality Management
ISO 14000 - Environmental Management
GMP - Good Manufacturing Practise
GLP - Good Laboratory Practise
NAMAS - National Accreditation of Measurment and Sampling
HACCP - Hazard Analysis Critical Control Points
What does a good quality system include?
- Motivated well trained workforce
-Well maintained plant
-Adequate capacity for peak demand
-Good plant cleanliness & house keeping - Sufficient time for operations, cleaning and maintenance
- Good relationships between suppliers and customers
What are examples of controlled documents?
Quality policy
Quality manual
Procedures
work instructions
Specification
HACCP systems
codes of practise
What must controlled documents be?
-Approved before issue
-Reviewed and updated
- Changes identified
-up-to-date
-legible
-external documents also controlled
obsolete documents removed
How is document control achieved?
Issuing on coloured paper or including colour logo
no photocopying
uniquely identified
pages numbered
maintaining distribution list of holders
ensuring documents are not issued without authorisation
only being available to staff who use them
limiting number of copies used.
Document change is controlled by …
Approval of changes before issue
issue of an amendment sheet so that changes are identified
keeping a master list of document numbers to ensure all staff use up to date copies.
retrieval of obsolete copies as replacements issued
archiving one copy
