Quality Risk Management Training Course

Participants can frame a risk assessment with clear scope, criteria and decision needs.

• Risk assessment charter defining purpose, scope, boundaries, and decision owner
• Writing precise risk questions before selecting an assessment method
• Process context captured through stakeholders, requirements, interfaces, and constraints
• Assumptions, exclusions, and evidence limitations recorded before assessment begins
• Risk criteria based on safety, compliance, customer impact, cost, and continuity
• Choosing qualitative, semi-quantitative, or quantitative assessment approaches

Participants can map a process to reveal critical steps, handoffs and control points.

• SIPOC diagrams establish suppliers, inputs, process boundaries, outputs, and customers
• Swimlane maps expose ownership gaps and cross-functional handoff failures
• Critical-to-quality requirements translated into measurable process specifications
• Inputs, activities, outputs, controls, and records mapped at each step
• Decision points and exception paths identified within the process flow
• Process maps validated against procedures, records, and frontline observations

Participants can identify quality risks systematically from process evidence and operational knowledge.

• Brainstorming rules separate possible failure causes from preferred solutions
• Checklists draw on complaints, audits, deviations, recalls, and near misses
• Ishikawa diagrams structure potential causes across people, methods, machines, materials
• Five Whys tests causal chains without treating symptoms as root causes
• Failure mode statements specify what fails, where, and under what conditions
• Hazard identification considers product, service, data, supplier, and process risks

Participants can analyse risk using consistent scoring scales and documented evidence.

• Likelihood scales anchored to historical frequency, exposure, and process conditions
• Impact scales distinguish customer harm, compliance breach, cost, and disruption
• Detectability ratings assess whether failure reaches the customer undetected
• Risk matrices combine likelihood and impact without false precision
• Scoring guidance reduces assessor bias and inconsistent risk classifications
• Evidence logs record data sources, assumptions, and confidence in ratings

Participants can complete an FMEA that prioritises meaningful quality risk actions.

• FMEA structure links functions, failure modes, effects, causes, and controls
• Severity ratings reflect credible consequences when the failure occurs
• Occurrence ratings use process capability, history, and known causal factors
• Detection ratings evaluate existing checks before release or customer use
• Action Priority tables direct resources beyond simple risk-priority numbers
• Recommended actions address prevention, detection, containment, and response

Participants can build a risk register that supports ownership, escalation and review.

• Risk register fields capture event, cause, consequence, controls, and owner
• Inherent and residual risk ratings show the effect of controls
• Action owners, target dates, dependencies, and status support accountability
• Escalation criteria identify risks requiring management or quality approval
• Risk treatment decisions recorded as accept, avoid, reduce, transfer, or monitor
• Version control preserves an auditable history of changing risk decisions

Participants can select proportionate controls that prevent, detect and contain quality failures.

• Control hierarchy prioritises elimination, substitution, engineering, administrative, and inspection controls
• Preventive controls reduce causal conditions before a failure develops
• Detective controls identify deviations before release, delivery, or escalation
• Corrective controls restore conformity after a confirmed quality failure
• Control plans specify methods, frequencies, records, owners, and reaction plans
• Poka-yoke designs prevent predictable human errors at source

Participants can use bow-tie analysis to connect threats, controls and consequences.

• Bow-tie diagrams place the top event between threats and consequences
• Threat barriers prevent initiating events from reaching the top event
• Recovery barriers limit consequences after the top event occurs
• Escalation factors identify conditions that weaken critical barriers
• Barrier ownership assigns testing, maintenance, and reporting responsibilities
• Critical control verification tests whether safeguards work as designed

Participants can connect investigations and CAPA actions to verified quality risks.

• Problem statements separate observed nonconformity from assumed root cause
• Five Whys and fishbone analysis structure investigation of contributing factors
• Cause-and-effect evidence distinguishes root causes from contributing conditions
• CAPA plans define correction, corrective action, preventive action, and ownership
• Effectiveness checks test whether CAPA actions reduced residual risk
• Recurring-event analysis identifies weak actions, trends, and systemic causes

Participants can assess quality risks before approving process, system or supplier changes.

• Change requests define proposed state, rationale, scope, and affected requirements
• Impact assessments examine documents, training, validation, suppliers, and controls
• Risk assessments identify new failure modes introduced by the change
• Pre-implementation controls include trials, approvals, training, and acceptance criteria
• Post-implementation review confirms outcomes, deviations, and residual risks
• Emergency changes require documented justification, containment, and retrospective review

Participants can assess supplier quality risks and define appropriate oversight controls.

• Supplier segmentation considers criticality, spend, substitutability, and quality history
• Due diligence reviews certifications, capability, controls, and financial stability
• Supplier scorecards track defects, on-time delivery, responsiveness, and audit findings
• Incoming inspection plans reflect material criticality and supplier performance
• Quality agreements define specifications, notification duties, deviations, and change approval
• Supplier corrective actions require root-cause evidence and effectiveness verification

Participants can plan audits that test the controls protecting the highest quality risks.

• Audit universes group processes, sites, suppliers, systems, and quality activities
• Risk-based audit plans prioritise critical processes and weak control environments
• Control objectives state what must be prevented, detected, or evidenced
• Audit tests examine design adequacy, operating effectiveness, and retained records
• Sampling approaches reflect risk, volume, history, and control frequency
• Findings distinguish isolated errors from systemic control failures

Participants can use quality data to identify emerging risks and control deterioration.

• Leading indicators signal control weakness before defects reach customers
• Lagging indicators measure complaints, rejects, rework, returns, and failures
• Pareto charts prioritise defect categories by frequency and consequence
• Run charts reveal shifts, trends, cycles, and unusual variation
• Control charts distinguish common-cause variation from special-cause signals
• Thresholds and triggers define escalation, investigation, and management response

Participants can communicate quality risks, decisions and residual exposures to different stakeholders.

• Risk reports distinguish facts, assumptions, uncertainty, and management recommendations
• Heat maps summarise exposure while retaining supporting assessment detail
• Management dashboards connect risks, controls, actions, indicators, and decisions
• Escalation messages state event, impact, immediate containment, and decision required
• Risk acceptance records document rationale, authority, duration, and review date
• Communication plans address operational teams, quality functions, executives, and suppliers

Participants can identify human-performance factors that increase the probability of quality failures.

• Human factors analysis examines workload, fatigue, competence, interfaces, and distractions
• Standard work reduces variation in repeatable quality-critical activities
• Training effectiveness verifies demonstrated competence rather than attendance records
• Visual management makes specifications, status, abnormalities, and actions visible
• Error-proofing controls address predictable slips, lapses, mistakes, and violations
• Shift handovers protect critical information during responsibility transfers

Participants can assess events quickly and determine proportionate containment and investigation actions.

• Triage criteria classify events by customer impact, severity, scope, and urgency
• Immediate containment protects customers, products, data, and operational continuity
• Deviation records capture chronology, affected population, evidence, and initial assessment
• Complaint investigations connect customer symptoms to process failure modes
• Impact assessments determine recall, notification, remediation, and monitoring needs
• Event trending identifies repeated signals requiring systemic risk reassessment

Participants can run management review discussions that drive accountable quality risk decisions.

• Management review inputs include risk trends, metrics, audits, CAPA, and changes
• Residual-risk reviews test whether accepted exposure remains within tolerance
• Control performance evidence supports retain, strengthen, redesign, or retire decisions
• Action logs record decisions, resources, owners, deadlines, and verification requirements
• Lessons learned update risk criteria, procedures, training, and assessment templates
• Annual risk review cycles align quality priorities with business planning

Participants can embed quality risk management into routine operational planning and decision-making.

• Daily management boards display critical quality controls and abnormal conditions
• Tiered meetings escalate unresolved risks through defined management levels
• Operational planning incorporates risk actions, resource needs, and control checks
• Quality objectives link process performance targets to material risk reduction
• Procedure design embeds risk checkpoints, records, approvals, and exception handling
• Risk ownership maps align accountability with authority and process knowledge

Participants can build, review and present a complete quality risk management dossier for a selected process.

• Process scope, quality requirements, stakeholders, and assessment question finalised
• Process map and critical control points reviewed for completeness
• FMEA and bow-tie analysis prioritise failure modes and barriers
• Risk register documents inherent risk, residual risk, actions, and ownership
• Control plan defines monitoring methods, response triggers, and verification evidence
• Management presentation states decisions required, resources, timelines, and residual exposure