Non-conformity Management Training Course

Comprehensive Non-conformity Management training covering ISO standards, root cause analysis, corrective actions.

Course Title

Non-conformity Management

Course Duration

1 Day

Competency Assessment Criteria

Practical Assessment and Knowledge Assessment

Training Delivery Method

Classroom (Instructor-Led) or Online (Instructor-Led)

Service Coverage

Saudi Arabia - Bahrain - Kuwait - Philippines

Course Average Passing Rate

98%

Post Training Reporting

Post Training Report(s) + Candidate(s) Training Evaluation Forms

Certificate of Successful Completion

Certification is provided upon successful completion. The certificate can be verified through a QR-Code system.

Certification Provider

Tamkene Saudi Training Center - Approved by TVTC (Technical and Vocational Training Corporation)

Certificate Validity

2 Years (Extendable with additional training hours)

Instructors Languages

English / Arabic / Urdu / Hindi / Pashto

Training Services Design Methodology

ADDIE Training Design Methodology

Course Overview

This comprehensive Non-conformity Management training course equips participants with essential knowledge and practical skills required for identifying, documenting, investigating, and resolving non-conformities in quality management systems to ensure regulatory compliance, customer satisfaction, and continuous improvement. The course covers fundamental non-conformity principles along with practical techniques for root cause analysis, corrective and preventive action implementation, and effectiveness verification to maintain organizational excellence and prevent recurrence.

Participants will learn to apply proven methodologies including Root Cause Analysis (RCA), 8D Problem Solving, CAPA (Corrective and Preventive Action), 5 Whys, and Fishbone Diagram to systematically investigate non-conformities, implement effective solutions, and drive quality improvements across the organization. This course combines theoretical concepts with practical applications and real-world case studies to ensure participants gain valuable skills applicable to their professional environment while emphasizing systematic approaches, documentation excellence, and prevention-focused thinking.

Key Learning Objectives

Understand fundamental non-conformity management concepts and requirements
Identify and classify non-conformities systematically
Conduct effective root cause analysis investigations
Develop and implement corrective and preventive actions
Document non-conformities and actions in compliance with standards
Verify effectiveness of implemented actions
Prevent non-conformity recurrence through systemic improvements
Support continuous improvement and organizational learning

Group Exercises

Non-conformity identification and classification workshop including (analyzing real-world scenarios from Middle East operations to identify non-conformities, classifying non-conformities by severity into major, minor, and critical categories, distinguishing between product non-conformities and system non-conformities, documenting non-conformity reports with complete and accurate information including evidence and impact assessment)
Root Cause Analysis and corrective action development including (applying Root Cause Analysis (RCA) techniques such as 5 Whys, Fishbone Diagram, and Fault Tree Analysis to non-conformity cases, identifying immediate causes versus root causes, developing effective corrective actions that address root causes rather than symptoms, creating preventive actions to avoid recurrence and prevent similar non-conformities)
Non-conformity investigation and disposition exercise including (conducting systematic investigation following 8D Problem Solving methodology, evaluating non-conforming products for disposition decisions including rework, repair, scrap, or use-as-is, assessing containment actions to prevent further occurrences, documenting investigation findings with objective evidence and factual analysis)
CAPA system management and effectiveness verification including (developing comprehensive Corrective and Preventive Action (CAPA) plans with timelines and responsibilities, implementing CAPA tracking systems with status monitoring, verifying effectiveness of corrective actions through follow-up audits and measurements, conducting trend analysis of non-conformities to identify systemic issues and improvement opportunities), and the importance of proper training in developing effective non-conformity management capabilities

Knowledge Assessment

Technical quizzes on non-conformity concepts including (multiple-choice questions on ISO requirements, matching exercise for RCA tools, classification scenarios)
Scenario-based assessments including (analyzing non-conformity situations, recommending investigation approaches, developing corrective actions)
Root cause analysis exercises including (applying 5 Whys technique, creating fishbone diagrams, identifying underlying causes)
CAPA evaluation including (assessing action effectiveness, reviewing documentation, ensuring compliance)

Course Outline

1. Introduction to Non-conformity Management

Non-conformity definition including (deviation from requirements, specification failure, standard breach)
ISO 9001 requirements including (clause 10.2, non-conformity and corrective action, quality management system)
Non-conformity types including (product non-conformity, process non-conformity, system non-conformity)
Non-conformity importance including (quality assurance, customer satisfaction, compliance maintenance)
Non-conformity versus non-compliance including (standard deviation, regulatory violation, distinction clarity)

2. Non-conformity Identification and Classification

Detection methods including (inspection, testing, audit findings)
Non-conformity sources including (internal audits, customer complaints, process monitoring)
Classification criteria including (severity, impact, frequency)
Grading systems including (major non-conformity, minor non-conformity, observation)
Documentation requirements including (non-conformity report, incident description, evidence collection)

3. Non-conformity Investigation

Investigation process including (information gathering, evidence collection, fact verification)
Immediate containment including (product isolation, process stoppage, risk mitigation)
Investigation team including (subject matter experts, quality personnel, cross-functional involvement)
Data collection including (measurements, records, witness statements)
Investigation documentation including (investigation report, findings summary, evidence trail)

4. Root Cause Analysis

Root cause versus symptom including (underlying causes, surface problems, distinction importance)
5 Whys technique including (iterative questioning, cause drilling, simplicity)
Fishbone Diagram including (Ishikawa diagram, cause categories, visual analysis)
Fault tree analysis including (logical relationships, failure pathways, systematic approach)
Root cause validation including (verification methods, testing hypotheses, confirmation)

5. Corrective Action Development

Corrective action definition including (eliminating causes, preventing recurrence, permanent solutions)
Action planning including (solution identification, responsibility assignment, timeline setting)
Action types including (immediate actions, short-term actions, long-term actions)
Action effectiveness including (feasibility, sustainability, cost-benefit)
Implementation planning including (resource allocation, milestone setting, monitoring approach)

6. Preventive Action Development

Preventive action definition including (proactive measures, potential problem prevention, risk mitigation)
Prevention opportunities including (trend analysis, risk assessment, best practices)
Preventive versus corrective including (timing, focus, application)
System improvements including (process enhancement, control strengthening, capability building)
Preventive action planning including (action identification, priority setting, implementation scheduling)

7. CAPA Implementation and Verification

Implementation process including (action execution, progress tracking, documentation)
Effectiveness verification including (verification methods, success criteria, measurement)
Verification timing including (short-term verification, long-term monitoring, sustained effectiveness)
Closure criteria including (action completion, effectiveness confirmation, documentation finalization)
Follow-up monitoring including (trend tracking, recurrence prevention, continuous surveillance)

8. Group Exercises

Root cause analysis workshop including (analyzing case study non-conformity, applying 5 Whys and fishbone diagram, identifying root causes)
CAPA development exercise including (developing corrective actions, planning implementation, defining verification methods)

9. Case Studies & Group Discussions

Manufacturing non-conformity examples including (product defects, process deviations, quality issues)
Service industry cases including (service failures, customer complaints, process breakdowns)
Recurring non-conformity scenarios including (inadequate corrective actions, root cause misidentification, systemic issues)
Successful CAPA implementation including (effective solutions, sustained improvements, organizational learning)
The importance of proper training in developing effective non-conformity management capabilities

Practical Assessment

Non-conformity investigation simulation including (conducting investigation, performing root cause analysis, documenting findings)
CAPA development project including (developing corrective action plan, creating preventive measures, establishing verification methods)
Documentation exercise including (completing non-conformity reports, writing investigation summaries, preparing closure documentation)

Gained Core Technical Skills

Applying non-conformity management frameworks including (ISO 9001 non-conformity and corrective action requirements, 8D Problem Solving methodology with disciplined approach, CAPA system implementation with systematic process, non-conformity lifecycle management from detection to closure)
Identifying and classifying non-conformities including (distinguishing non-conformities from observations and opportunities for improvement, categorizing by severity as major, minor, or critical, differentiating product versus system non-conformities, assessing impact on quality, safety, and compliance)
Conducting Root Cause Analysis (RCA) including (applying 5 Whys technique for iterative questioning, utilizing Fishbone Diagram (Ishikawa) for cause categorization across methods, materials, machines, people, and environment, implementing Fault Tree Analysis for complex failures, using Pareto Analysis to prioritize issues)
Developing corrective and preventive actions including (formulating effective corrective actions that address root causes, designing preventive actions to avoid recurrence, ensuring actions are specific, measurable, achievable, and time-bound, prioritizing actions based on risk and impact assessment)
Managing non-conforming products and materials including (implementing containment actions to prevent use or delivery, evaluating disposition options including rework, repair, scrap, return, or use-as-is with concession, conducting segregation and identification of non-conforming items, managing customer notification and regulatory reporting requirements)
Implementing CAPA tracking systems including (documenting non-conformities with complete information and evidence, assigning responsibility and establishing timelines for resolution, tracking CAPA status through implementation and verification, maintaining centralized non-conformity database and records)
Verifying effectiveness of corrective actions including (defining verification criteria and methods for action effectiveness, conducting follow-up audits and inspections, monitoring performance metrics and trend data, confirming root cause elimination and non-recurrence, documenting verification results and closure)
Conducting non-conformity trend analysis including (collecting and analyzing non-conformity data over time, identifying patterns and recurring issues, performing Pareto analysis to focus on vital few problems, reporting trends to management for systemic improvements, integrating findings into management review)
Managing non-conformity documentation and records including (preparing non-conformity reports with objective evidence, maintaining traceability from identification through closure, ensuring compliance with ISO standards and regulatory requirements, conducting document control and retention per requirements)

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Training Design Methodology