CQP Foundation Level

Quality Planning, Risks and Opportunities Management flashcards

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How does KS ISO 9000 define quality planning, and what are its three elements?

The part of quality management focused on setting quality objectives and specifying the necessary operational processes and related resources to achieve those objectives. Elements: setting quality objectives, specifying operational processes, and specifying resources.

What is the difference between a quality policy and a quality objective?

Quality policy: the intentions and direction of an organisation related to quality, as formally expressed by top management. It states what the organisation commits to, not how. Quality objective: a result to be achieved related to quality, specific, measurable and time-bound, derived from the policy.

How do ISO 31000 and ISO 9000 define risk, and what is deliberate about the definition?

Risk is the effect of uncertainty on objectives. An effect is a deviation from the expected, positive or negative; uncertainty is a deficiency of information; and risk is always relative to an objective, so an organisation with no stated objective has no identifiable risk.

What is the difference between pure and speculative risk, and which can be insured?

Pure risk: the only outcomes are loss or no loss, such as fire, theft or injury. Speculative risk: the outcome may be gain or loss, such as a new product or an exchange-rate position. Only pure risk is insurable, because insurance needs a fortuitous loss and an insurable interest; speculative risk is managed by the business.

What is the formula for the net annual value of a control?

V = (P0 x I0) - (P1 x I1) - C P0, I0: probability and impact before the control (inherent). P1, I1: probability and impact after the control (residual). C: the annualised cost of the control.

Who sits in each line of the three lines model, and what does each do?

First line: operational management and staff, who own and manage risk and operate the controls. Second line: risk, compliance, quality and other oversight functions, who set the framework, advise, challenge, monitor and report, but do not own the risks. Third line: internal audit, giving independent assurance and reporting to the audit committee. Outside the lines: external audit, regulators and certification bodies.

What is an opportunity, and how does it relate to risk under ISO 31000?

A set of circumstances which makes it possible to do something. Taking it is not always right, and it may carry risk of its own. Since risk is the effect of uncertainty on objectives and that effect may be positive, an opportunity is the positive tail of the same distribution, not a different subject.

How should a risk be written so that a treatment follows from it?

As cause, event and consequence. Each treatment then follows from one part: for a single-source supplier, qualify a second supplier (cause), monitor the supplier's financial health (event), and hold more stock cover (consequence). 'Supply chain risk' on its own has no cause, event or consequence, so no treatment can be derived.

What five things does clause 6.2.2 require to be determined for each quality objective?

What will be done. What resources will be required. Who will be responsible. When it will be completed. How the results will be evaluated.

How is the risk priority number worked out in FMEA, and how is detection scored?

RPN = S x O x D, each scored 1 to 10: severity of the effect, likelihood of occurrence of the cause, and detection. Detection is inverted: 10 means the failure would not be detected before reaching the customer. The RPN is a ranking device, not a measurement.

What are the steps of Juran's quality planning roadmap?