Risk Management and Analysis

Every specialist in the area of Quality & Reliability needs at least general knowledge about Risk Management (its objectives and functions). Moreover, he/she needs a certain criteria to decide what tool or technique supporting Risk Management (RM) is more appropriate for the operation area of his/her organization.

Below you can see a list presenting seven main techniques used in industry and civil engineering for process/product improvement and project management:
•  HAZOP (Hazard Operability Analysis)
•  ETA (Event Tree Analysis)
•  LOPA (Layer of Protection Analysis)
•  HACCP (Hazard Analysis of Critical Control Points)
•  FTA (Fault Tree Analysis)
•  FMECA (Failure Mode, Effect and Criticality Analysis)

ALD's team of RM experts uses all these techniques and provides support in their implementation in different areas: Chemical Industry, Medical Devices, Safety, Food Industry, Complicated Control Systems, Civil Engineering, Defense Industry and more.

Quality Risk Management (QRM)

QRM deals with decision making regarding possible or arising quality problems during the entire product lifecycle.
QRM is always a joint responsibility among decision makers from various functions and departments (not only QA). QRM provides necessary tools & techniques, allocates resources and facilitates all activities designed to meet formal requirements of Regulatory Authorities and standards, related to given business area.

QRM is usually driven by:
•  Planned Activities – Design Reviews, Product/Process Reviews, Validation & Verification, Inspections, Audits, Change Control, Training, etc.
•  Unplanned Activities – MRB, Recalls, Complaints, Directives of Regulatory Authorities, etc.

ALD's methodology of Quality Risk Management covers all typical activities at both Design and Manufacturing phases dealing with:
•  Risk Identification, Characterization and Assessment
•  Risk Retention
•  Risk Reduction and Mitigation
•  Risk Monitoring and Control

ALD will assure an accurate and detailed Risk Management and Analysis process for your organization or company.