Skip to main content
Problem Solving in Quality Management Systems

Problem Solving in Quality Management Systems

$249.00
Who trusts this:
Trusted by professionals in 160+ countries
Your guarantee:
30-day money-back guarantee — no questions asked
How you learn:
Self-paced • Lifetime updates
Toolkit Included:
Includes a practical, ready-to-use toolkit containing implementation templates, worksheets, checklists, and decision-support materials used to accelerate real-world application and reduce setup time.
When you get access:
Course access is prepared after purchase and delivered via email
Adding to cart… The item has been added

This curriculum spans the full lifecycle of quality problem solving in regulated environments, comparable to the structured workflows used in multi-phase CAPA investigations and cross-functional audit readiness programs within medical device or pharmaceutical organisations.

Module 1: Defining and Scoping Quality Problems

  • Selecting which non-conformances to escalate for root cause analysis based on regulatory exposure, customer impact, and recurrence frequency.
  • Deciding whether to use a Pareto analysis or a risk-prioritized matrix to focus investigation efforts on high-impact quality events.
  • Determining the appropriate boundary of a problem (e.g., single process vs. cross-functional workflow) when symptoms appear in multiple departments.
  • Choosing between reactive problem scoping (post-failure) and proactive scoping (during management review or audit findings).
  • Establishing criteria for when a deviation requires a formal investigation versus local corrective action.
  • Documenting problem statements using SMART criteria while ensuring alignment with ISO 9001:2015 clause 10.2 on nonconformity and corrective action.

Module 2: Root Cause Analysis Method Selection and Execution

  • Selecting between 5 Whys, Fishbone diagrams, and Fault Tree Analysis based on problem complexity, data availability, and team expertise.
  • Deciding how deeply to drill with 5 Whys when initial answers point to procedural non-compliance versus systemic gaps.
  • Facilitating cross-functional RCA teams while managing conflicting interpretations of evidence from operations, QA, and engineering.
  • Validating root cause hypotheses using objective data (e.g., batch records, equipment logs) rather than anecdotal input.
  • Handling situations where multiple root causes are identified and prioritizing which to address first based on risk mitigation potential.
  • Ensuring RCA outputs meet regulatory expectations for thoroughness in FDA 21 CFR Part 820 or ISO 13485 environments.

Module 3: Designing and Validating Corrective and Preventive Actions (CAPA)

  • Writing CAPA objectives that are measurable and time-bound, avoiding vague actions like “improve training” without specifying metrics.
  • Choosing between process redesign, additional inspection points, or automation based on the root cause and cost of delay.
  • Validating the effectiveness of a corrective action by defining a verification method (e.g., audit, statistical process control) and a timeline.
  • Deciding whether to implement a temporary containment action while a permanent solution is developed and validated.
  • Assessing the risk of unintended consequences when modifying a controlled process (e.g., change control implications).
  • Linking CAPA actions to change control systems to ensure traceability and prevent unauthorized process modifications.

Module 4: Integrating Problem Solving with Risk Management Systems

  • Mapping identified quality problems to FMEA updates, including recalculating RPNs and adjusting control plans.
  • Using risk assessment outputs to justify not pursuing certain corrective actions due to low severity or detectability.
  • Aligning problem-solving timelines with risk review cycles (e.g., quarterly management reviews or annual product quality reviews).
  • Deciding when a quality problem triggers a formal risk assessment under ISO 14971 or similar standards.
  • Documenting risk-based decisions to not act on certain issues, ensuring defensible audit trails.
  • Integrating risk communication protocols when a quality issue affects product safety or regulatory compliance.

Module 5: Cross-Functional Collaboration and Escalation Protocols

  • Establishing RACI matrices for problem-solving teams to clarify accountability between QA, operations, engineering, and supply chain.
  • Defining escalation thresholds for unresolved issues, including time-based triggers and severity criteria.
  • Negotiating resource allocation for problem-solving when departments have competing priorities.
  • Facilitating joint problem-solving sessions between internal teams and external suppliers or contract manufacturers.
  • Resolving conflicts when functional areas disagree on root cause or resist ownership of corrective actions.
  • Using structured communication tools (e.g., A3 reports, escalation dashboards) to maintain alignment across leadership levels.

Module 6: Data-Driven Decision Making in Quality Investigations

  • Selecting appropriate statistical tools (e.g., control charts, hypothesis testing) based on data type and sample size limitations.
  • Integrating data from LIMS, MES, and ERP systems to reconstruct process conditions during a failure event.
  • Deciding when to treat an outlier as a special cause versus common cause variation using SPC rules.
  • Validating data integrity before analysis, especially when electronic records are involved and ALCOA+ principles apply.
  • Using trend analysis to distinguish isolated incidents from systemic quality degradation over time.
  • Presenting data findings in a way that supports decision-making without overinterpreting limited datasets.

Module 7: Sustaining Improvements and Preventing Recurrence

  • Updating controlled documents (SOPs, work instructions) after CAPA completion and ensuring version control.
  • Scheduling follow-up audits to verify that corrective actions remain effective beyond initial implementation.
  • Training affected personnel on revised processes with documented competency assessments.
  • Monitoring key performance indicators post-CAPA to detect regression or new failure modes.
  • Revising supplier agreements or incoming inspection criteria when recurrence risks extend to purchased materials.
  • Incorporating lessons learned into onboarding programs and internal audit checklists to institutionalize improvements.

Module 8: Regulatory and Audit Readiness in Problem Solving

  • Ensuring investigation documentation meets requirements for inspection by FDA, Notified Bodies, or other regulators.
  • Preparing for audit inquiries by organizing problem-solving records in a retrievable, chronological structure.
  • Responding to observations (e.g., 483s, audit findings) with evidence-based CAPA plans and timelines.
  • Reconciling internal problem classifications with regulatory reporting obligations (e.g., MDRs, field safety notices).
  • Conducting mock audits of high-risk investigations to test documentation completeness and team readiness.
  • Managing document retention policies for problem-solving records in alignment with regulatory preservation periods.
!