Week 1 Flashcards
Define Quality
Quality is conformance to requirements or specifications
Define Specification
A document that prescribes in detail the requirements with which the product or service has to comply
Define Conformity
The fulfilment of a specified requirement by a quality characteristic the assessment of which does not depend essentially on time
Define Reliability
The ability of an item to perform a required function under stated conditions for a stated period of time
Define Inspection
The process of measuring, examining, testing, gauging or comparing characteristics with specified requirements to determine conformity
What are the stages of inspection and use a diagram to show the inspection balance?
- Inspect
- Record
- Analyse
- Correct
What are the differences between inspection by variables and inspections by attributes?
By variables:
Inspection wherein characteristics are evaluated against a numerical scale and are expressed as points along it. Numerical value
By attributes:
Inspection whereby characteristics are assessed without measurement but are classified as conforming or not conforming. Pass or fail
Define and discuss the use of process validation
Typically used within safety-critical areas like pharmaceuticals and medical devices, Process Validation is the analysis of data gathered throughout the design and manufacturing of a product in order to confirm that the process can reliably output products of a determined standard when 100% inspection is not possible.
The purpose of process validation is to ensure varied inputs lead to consistent and high-quality outputs. Process validation is an ongoing process that must be frequently adapted as manufacturing feedback is gathered. End-to-end validation of production processes is essential in determining product quality because quality cannot always be determined by finished-product inspection.
Process validation can be broken down into 3 steps:
process design,
process qualification, and
continued process verification.
In process validation, discuss the meaning of the acronyms IQ, OQ and PQ?
IQ Installation Qualification
(All key aspects of equipment adhere to specification)
OQ Operational Qualification
(consistent operation of equipment under normal conditions, alarms, operating ranges, etc.)
PQ Product Qualification
(produce in spec product when operated under challenged conditions)
Describe Total Quality management and its use.
TQM implies a top-management led company-wide approach involving all employees and focusing on prevention rather than detection and correction. Customer orientation and teamwork are key features. The emphasis is on quality in all aspects and functions of the company operation.
A management philosophy embracing all activities through which the needs and expectations of the customer and the community, and the objectives of the organisation are satisfied in the most efficient and cost-effective way by maximising the potential of all employees in a continuing drive for improvement (BS 4778 Pt 2)
- Strong management
- Clear focus on customer needs
- Continual improvement (processes, services and products), cost, productivity and quality
- Empowerment of individual staff as part of teams
- Variability reduction and fact-based decision making
- Supplier relationships
Management philosophy and company practices that aim to harness the human and material resources of an organisation in the most effective way to achieve the objectives of the organisation
- (BS 7850 Pt 1)
Describe Lean manufacturing and its use.
Lean Manufacturing – Central idea is to reduce waste by removing or reducing tasks which don’t add value from the customer’s viewpoint, three categories, value creating, incidental and waste. Often including JIT to reduce inventory
Describe Six sigma and its use.
Six Sigma looks at specific projects
Quite similar to TQM but focuses on training select people and the use of statistical tools
- MEASURE
- ANALYSE
- IMPROVE
- CONTROL (MAIC)
Quality improvement technique that aims to reduce defect levels
Six sigma refers to 6 standard deviations between the mean and specification limit
Customer focus and employee involvement. Use a number of statistical tools (such as DOE, SPC, etc)
Staff trained in six sigma are known as green belt, black belt etc.
What are the advantages and disadvantages of Inspection
What are the advantages and disadvantages of using TQM and Six Sigma
What is Kaizen:
A philosophy of continuous improvement of all employees so that they perform their tasks a little better each day.
Gradual, unending improvement doing ‘little things’ better, setting - and achieving - even-higher standards.
What is Poka Yoke
Mistake proofing
Introduce checks into the system so that if a mistake is made, or in the course of being made, the system will stop until the mistake is corrected
