hazard operability analysis method specification
IRI: https://spec.industrialontologies.org/ontology/construct/HazardOperabilityAnalysisMethodSpecification
Defined In: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaRiskManagement/
SubClass Of: risk management method specification
Class Hierarchy
owl:Thing › bfo:entity › bfo:continuant › bfo:generically dependent continuant › information content entity › plan specification › risk management method specification › hazard operability analysis method specification
Definition
risk management method specification that prescribes the systematic qualitative identification of potential hazards and operability problems in a process, evaluation of their causes, consequences, and existing safeguards, and, where appropriate, identification of recommended risk-reduction action
Explanatory Notes
Hazard and Operability Analysis (HAZOP) is a structured, systematic, qualitative technique for identifying potential risks and operability problems in a process, their causes and consequences, evaluating whether the existing safeguards are adequate to prevent hazardous situations and recommending risk reduction actions, where appropriate. It breaks complex processes into manageable elements. “Guide words” (e.g., No/None, High/More, Low/Less, Reverse, Early, Late, etc.) are applied to process parameters of each element to help identify potential deviations from normal values or design intentions. For each deviation, causes, consequences, and existing safeguards are analyzed. If risks are unacceptable or safeguards are insufficient, risk reduction actions are recommended.
Examples
- A HAZOP method specification for a monoclonal antibody bioreactor operation prescribes that the team analyze deviations for selected process parameters, document their causes, consequences, and existing safeguards, and recommend risk-reduction actions where needed. When carried out, the resulting HAZOP record includes deviations involving temperature, pH, dissolved oxygen, agitation rate, and nutrient feed rate, and identifies issues such as pH probe drift and setpoint-entry error together with recommendations such as more frequent calibration, redundant sensing, and improved entry controls; A HAZOP method specification for an ortho-xylene oxidation reaction in a fixed-bed catalytic reactor prescribes that the team analyze deviations for selected process parameters, document their causes, consequences, and existing safeguards, and recommend risk-reduction actions where needed. When carried out, the resulting HAZOP record includes deviations involving feed and coolant conditions, feed composition, and catalyst activation, and identifies thermal runaway as a critical outcome, with recommendations such as detailed study of safe operating limits and installation of interlocks and relief systems.
Adapted From
- https://www.ema.europa.eu/en/documents/scientific-guideline/international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use-ich-guideline-q9-quality-risk-management-step-5-first-version_en.pdf
Primitive Class
This class is declared primitive and it does not have necessary and sufficient condiftions defined.
Primitive Rationale
There are insufficient constructs to create a set of necessary and sufficient conditions
Formal Axioms
First-Order Logic Axioms
HazardOperabilityAnalysisMethodSpecification(x) → RiskManagementMethodSpecification(x)
Semi-Formal Natural Language Axioms
if x is a ‘hazard operability analysis method specification’ then x is a ‘risk management method specification’