CQP Foundation Level
Quality Management Systems flashcards
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How does KS ISO 9000 define quality, and what do 'inherent' and 'requirements' mean in that definition?
The degree to which a set of inherent characteristics of an object fulfils requirements. Inherent: belonging to the thing itself, not assigned to it, so price is not a quality characteristic. Requirements: a need or expectation that is stated, generally implied or obligatory.
What did Deming argue about the cause of quality problems, and what is he remembered for?
Most quality problems, roughly 85 to 94 per cent, are caused by the system, which is management's responsibility, not by workers. He is remembered for the Fourteen Points for Management, the Seven Deadly Diseases, the System of Profound Knowledge, and the Plan-Do-Check-Act cycle he popularised from Shewhart's work.
What are the five SERVQUAL dimensions, and how does SERVQUAL measure service quality?
Reliability, assurance, tangibles, empathy and responsiveness. Service quality = perception - expectation: the gap between what the customer expected and what the customer perceived. Reliability is consistently the highest-weighted dimension.
Name the seven quality management principles of KS ISO 9000.
1. Customer focus 2. Leadership 3. Engagement of people 4. Process approach 5. Improvement 6. Evidence-based decision making 7. Relationship management
How does the PDCA cycle map onto the clauses of KS ISO 9001:2015?
Plan: clauses 4 Context, 5 Leadership, 6 Planning and 7 Support. Do: clause 8 Operation. Check: clause 9 Performance evaluation. Act: clause 10 Improvement. Each turn should leave the process higher than the last; a cycle that returns to the same level is maintenance, not improvement.
Distinguish quality of design, quality of conformance and quality of performance.
Design: how well the specification reflects what the customer needs. Set before production, and the most expensive failure to correct. Conformance: how well the delivered output matches its specification. Measured by defect rate, first-pass yield and capability indices. Performance: how the product behaves in the customer's hands over its life. Its field feedback should reopen the design.
Who develops, adopts, accredits and certifies when a Kenyan firm is certified to KS ISO 9001:2015?
ISO develops and publishes the standard. It certifies nobody and issues no certificates. KEBS, Kenya's national standards body and ISO member, adopts it as KS ISO 9001:2015. KENAS, the national accreditation body, accredits certification bodies and laboratories. An accredited certification body audits the firm's system and issues the certificate. The firm is certified to a standard, never 'by ISO'.
What strategy does Mendelow's grid give for each combination of power and interest?
Low power, low interest: minimal effort, monitor only. Low power, high interest: keep informed. High power, low interest: keep satisfied. High power, high interest: manage closely as a key player. Positions are not fixed: a low-interest regulator becomes a key player the moment a product incident is reported.
Under clause 5, what may top management delegate, and what may it not?
It may assign responsibility and authority, for example for running a process or reporting on the system's performance. It may not delegate accountability for the effectiveness of the quality management system. The 2015 edition removed the management representative role that used to let a chief executive hand the whole system to a quality manager.
What is the difference between correction and corrective action?
Correction eliminates the detected nonconformity, for example rejecting or reworking the batch. Corrective action eliminates its cause so it does not recur, for example recalibrating and re-validating the filler and retraining the operator. Correction without corrective action guarantees recurrence.
Distinguish quality control from quality assurance.
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What is the difference between quality and grade?
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Name the five quality eras and say who owned quality in each.
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When were the first ISO 9000 series, KEBS and KENAS established?
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How did Juran define quality, and what are the three stages of his Quality Trilogy?
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What did Armand Feigenbaum contribute to quality management?
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What is Kaoru Ishikawa remembered for?
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State Taguchi's quality loss function and the point it makes.
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What is Shigeo Shingo remembered for?
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What are the four elements of Crosby's Four Absolutes of Quality?
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Name Garvin's eight dimensions of product quality.
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Why is reputation said to be asymmetric, and how is it recovered?
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Why did the 2015 edition reduce the quality management principles from eight to seven?
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Does the evidence-based decision making principle exclude judgement?
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How does KS ISO 9000 define a process, and what three consequences follow?
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What is SIPOC, and why is it filled in from the customer end?
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Distinguish a procedure, a work instruction, a form and a record.
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How does business process re-engineering differ from continual improvement (kaizen)?
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What are the nine Ms, the factors affecting the quality of a product or service?
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What is ISO, and where does its name come from?
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What do KS ISO 9000, 9001, 9004 and 19011 each provide?
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What does certification to ISO 9001 prove, and what does it not?
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What is an interested party, and what must the organisation do about interested parties?
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What does PESTEL stand for, with a Kenyan manufacturer's issue for each?
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What three tests decide whether an interested party's need becomes a requirement of the system?
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What must a quality policy satisfy under clause 5.2?
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Which five responsibilities must top management assign under roles, responsibilities and authorities?
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How is symbolic leadership commitment distinguished from substantive commitment?
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What are Kotter's eight steps for leading change?
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What are the three parts of planning under clause 6, and does it require a risk register?
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What must quality objectives be, and what must the plan to achieve them state?
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What does KS ISO 9001:2015 require of measuring equipment where traceability is a requirement?
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Why is competence not the same as training under clause 7.2?
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Distinguish design review, design verification and design validation.
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What are the four permitted dispositions for nonconforming output under clause 8.7?
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What is a special process, and what does clause 8.5 require for it?
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What are Schein's three levels of culture, and which one determines behaviour?
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What does genuine empowerment for quality require?
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Which Kenyan laws can a quality-related integrity failure engage?
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Why does Garvin's list of product dimensions not transfer to services, and what framework replaces it?
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Why does the reputational calculus favour an early voluntary recall over waiting for KEBS or the Pharmacy and Poisons Board to compel one?
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What does the leadership principle of KS ISO 9000 state, and what actions apply it?
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What does the relationship management principle require, and why?
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What determines quality of design, and which formal technique translates the voice of the customer into engineering characteristics?
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Which function is primarily accountable for quality of design, for quality of conformance and for quality of performance?
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A solar home system meets its specification but its 40 Ah battery is flat by 9 p.m.; a correctly built borehole pump fails in a high-silt aquifer. Which type of quality failure is each?
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Which two features of the 2015 edition of ISO 9001 are examined regularly?
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How is a quality system kept aligned with strategy rather than running as a parallel administrative structure?
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What resources must the organisation determine and provide under clause 7.1?
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Under clause 8.2, what must be reviewed before the organisation commits to supply, and why?
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What is the simple diagnostic question for an organisation's quality culture, and what does a 'ship it anyway' answer reveal?
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Why is recognition stronger than cash incentives for sustaining a continual improvement culture?
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