Professional Documents
Culture Documents
1.1.1. Quality Risk Assessment. 1.1.1.1. Introduction & Scope
1.1.1. Quality Risk Assessment. 1.1.1.1. Introduction & Scope
Give assurance that the Quality Management system can achieve its intended
results.
Enhance the desirable effects.
Prevent or reduce the undesirable effects.
Achieve improvement.
The Project Manager shall ensure that all TARGET personnel and subcontractor
personnel undertaking or verifying work relating to this project do so in accordance
with the authorities and responsibilities defined and are provided with appropriate
instructions and, in doing so, ensure actions are initiated to:
1.1.1.2. Definitions
Risk
Actions to Monitor
Identify Prioritize Responses
addressed &
the Risks Risks & Risk
risks Control
Owners
1.1.1.4. Identification of Risks
The quality assurance representative and all on-site and offsite verification personnel
shall have the authority to hold the process which might, after evaluation and
reconsideration, give rise to non-conformity and to embargo non-conforming
products pending remedial action, with immediate reference to the Project
Management. While in the process of identifying the following technics, not limited
to, shall be used.
Prioritization of the risk shall be based on the risk rating, by assessing each identified
risk for the probability of occurrences and impacts.
PROBABILITY OF OCCURANCE
Criteria
Rating Probability Level
The event occurring frequently
5 Almost Certain Strong likelihood of future recurrence.
Event occurrence of multiple times per month in the area of operation.
The event to occur on a regular basis.
Subjective evidence to show medium frequency.
4 Likely
Existence of substantial opportunity for risk of this nature.
The average of occurrence only once per month
Events of infrequent occurrence but with some reasonable opportunity
for occurrence.
The event which happened before.
3 Possible
The event occurs annually (but not more than one per month on an
average)
The event which occurred in other companies executing the same kind
of work.
Unlikely Very few recorded/known events.
2
Some opportunity to occur only in exceptional circumstances.
The event which occurs once in two years.
IMPACT
Criteria
Rating Probability Level
5 Critical One or more critical outcome where objectives will not be achieved.
Large scale changes/ requirement of strategy revision
One or more stated outcome wherein objective will fall below
4 Major acceptance criteria.
Significant changes required.
One or more stated outcome resulting in objectives fall below the goal
3 Moderate but above minimum acceptance levels.
Moderate changes required
One or more stated outcome resulting in objectives falls below the goal
Minor but well above minimum acceptance criteria.
2
No changes required.
IMPACT
Negligible Minor Moderate Major Critical