Quality Risk Management

Programme Summary

Make quality risk decisions that are transparent, proportionate and grounded in evidence. Participants define the product or process question, compare suitable assessment methods and link risk controls with verification and review. Practical cases address uncertainty, subjectivity and escalation, helping teams avoid mechanical scoring and focus resources on failures that could materially affect customers, product performance or intended use.

Training Objectives

1 Frame quality risks around intended use; 2 Select proportionate risk assessment methods; 3 Strengthen evidence and reduce subjective scoring; 4 Link controls with residual risk review; 5 Integrate risk decisions into quality activities.

Learning Outcomes

1 Define a clear quality risk question; 2 Prepare a structured risk assessment; 3 Justify controls against identified failure mechanisms; 4 Document residual risk and acceptance authority; 5 Set practical risk review and escalation triggers.

Target Audience

Quality Engineers; Process Engineers; Quality Managers; Production Supervisors; Continuous Improvement Specialists.

Target Industries

Pharmaceutical Manufacturing; Medical Device Manufacturing; Automotive Manufacturing; Food Packaging Manufacturing; Industrial Equipment Manufacturing.

Course Contents

• Module 1 Quality Risk Decision Context: Intended use and customer consequences; Scope assumptions and available evidence; Roles and accountable risk decisions.
• Module 2 Risk Identification: Failure scenarios and process interfaces; Sources of hazards and quality defects; Past incidents complaints and technical knowledge.
• Module 3 Selecting Assessment Methods: Simple screening and structured analysis options; Method suitability and complexity tradeoffs; Qualitative and quantitative evidence limitations.
• Module 4 Risk Evaluation: Severity likelihood and detectability distinctions; Transparent criteria and uncertainty treatment; Avoiding arithmetic scores as sole justification.
• Module 5 Risk Control: Prevention reduction and detection choices; Verification of control effectiveness; Unintended effects and residual exposure.
• Module 6 Risk Acceptance and Communication: Decision authority and documented rationale; Escalation of unacceptable or uncertain risks; Clear communication to affected stakeholders.
• Module 7 Lifecycle Review: Changes new knowledge and performance signals; Periodic review proportional to risk; Linking risks with corrective action and planning.
• Module 8 Quality Risk Workshop: Assessing a bounded quality scenario; Comparing controls and residual risks; Presenting a justified risk decision record.

Assessment

• 40 single best answer questions, including applied scenarios; one mark per question.
• 60 minute invigilated digital examination with identity verification. Approved accessibility adjustments preserve the assessed competence.
• Supplied reference pack and calculator permitted; external internet and AI prohibited.
• Individual applied assessment (30 minutes): Complete a quality risk assessment for a supplied scenario, justify selected controls and document residual risk, uncertainty and review triggers.
• Assessment criteria: Clear scenario and consequence analysis; Proportionate evidence based control selection; Transparent residual risk and review decisions.
• Pass each component separately: 30/40 written marks (75%) and at least 70% on the applied task.
• Individual results and feedback are provided. One reassessment may follow coaching under the published enrolment terms.

Certification

• Successful learners receive a TQCSI Arabia digital Certificate of Successful Completion.
• The certificate records the learner name, exact programme title, teaching hours, completion date and unique verification reference.
• Verified identity, full attendance and separate written and applied passes are required; all mandatory critical criteria must be met.
• Proposed issue target: within 30 calendar days of approved results and settlement of applicable fees.
• Records quality risk assessment learning; product safety, regulatory and risk acceptance authority remain organisation specific.
• Attendance confirmation may record completed hours for unsuccessful learners; it does not certify successful completion.

Programme Profile

Number of daysNumber of daysNumber of days

222

Total teaching hoursTotal teaching hoursTotal teaching hours

12 hours; breaks, pre course work and formal final assessments excluded.12 hours; breaks, pre course work and formal final assessments excluded.12 hours; breaks, pre course work and formal final assessments excluded.

Delegates allowedDelegates allowedDelegates allowed

Maximum 20 delegates.Maximum 20 delegates.Maximum 20 delegates.

Training prerequisitesTraining prerequisitesTraining prerequisites

Quality or technical process experience is required. Basic familiarity with root cause analysis and product requirements is recommended.Quality or technical process experience is required. Basic familiarity with root cause analysis and product requirements is recommended.Quality or technical process experience is required. Basic familiarity with root cause analysis and product requirements is recommended.

Pre course assignment and assessmentPre course assignment and assessmentPre course assignment and assessment

Review a fictional product quality concern for 25 minutes and identify possible consequences and evidence gaps.Review a fictional product quality concern for 25 minutes and identify possible consequences and evidence gaps.Review a fictional product quality concern for 25 minutes and identify possible consequences and evidence gaps.

End of course assessmentEnd of course assessmentEnd of course assessment

40 question written exam (60 minutes) and individual applied task (30 minutes).40 question written exam (60 minutes) and individual applied task (30 minutes).40 question written exam (60 minutes) and individual applied task (30 minutes).

Passing criteriaPassing criteriaPassing criteria

75% written and 70% applied, passed separately; full attendance.75% written and 70% applied, passed separately; full attendance.75% written and 70% applied, passed separately; full attendance.