API

API Auditing Fundamentals

API Specification Q1 or API Specification Q2

API Specification Q1 or API Specification Q2

API

COURSE HIGHLIGHTS:

This multi-day course focuses on the principles of effectively auditing your quality management systems, including API Specification Q1 or API Specification Q2. Topics covered include:

  • Applying the principles, procedures and techniques of planning and conducting effective audits
  • Managing the audit process from planning to reporting to closing out nonconformities.

 

LEARNING OUTCOMES:

By the end of this course, participants should be able to:

  • Define key auditing concepts, ethics, and standards used in the auditing process
  • Demonstrate how to develop an audit program
  • Understand how to conduct an effective audit
  • Execute post audit activities

 

CEUS AND CERTIFICATES:

This course is accredited by the International Association of Continuing Education and Training. Participants meeting the requirements of the course will be awarded the following:

  • CEUs: 1.4
  • Certificate: A certificate of completion will be awarded to participants who successfully complete the requirements of the class and the practical assessment.

 

KEY BENEFITS FOR EMPLOYEE AND EMPLOYER:

  • Develop API Q1 and Q2 auditors , who can do internal and external audits
  • Team Obtain skills to plan, schedule and perform , report and follow up audits.
  • Identify the benefits and aim of API Q1 & Q2 audits.
  • Obtain globally recognized certification.
  • Learn with experience from TUV SUD auditors and experts.

TRAINING DURATION

2 Days


OUTLINE:

 

  • Module 1
    • Welcome address.
    • Training protocols.
    • Group activity.
    • Platforms used for Training
    • Activity – 1.1 Introduction
    • Activity – 1.2 Training expectation.
    • Activity – 1.3 Group exercise – Video – Case Study.
    • Terms and definition – Basics Audit.
    • Activity – 1.4
  • Module 2A
    • Principles and Audit Program Management.
    • Principles of Audit.
    • Types of Audits
    • Types of Oil and Gas Companies
    • List of Characteristics that impact on Audits.
    • Preparation for Establishing API Audit Program.
    • Inputs for programming.
    • Auditor Objectives.
    • Competences and Skills.
    • Extend of Audit Program
    • Multi Locations and Logistics.
    • Group Case- Risk Evaluation for Audit Programs and Execution.
    • Activity 2.1 -Awareness Discussion
    • Activity 2.2 -Group activity.
    • Activity 2.3 - Group activity.
    • Activity 2.4 - Group activity.
    • AUDIT Program – ELEMENTS.
    • Objectives for Audit Program.
    • Activity 2.5 - Group activity.
    • Importance of Risks and Opportunities for Audits.
    • Roles and responsibilities for the individual Managing the Audit Program.
    • Competence of Auditors and its importance.
  • Module 2B
    • IMPLEMENTING AUDIT PROGRAMME.
    • Implementing Audit Programme
    • Audit methods
    • Objectives - Audit Programme.
    • Scope - Audit Programme.
    • Review - Scope for Manufacturing Companies.
    • Review - Scope for Servicing Companies.
    • Audit Criteria.
    • Audit Methods  and Types
    • Risk of Remote audits
    • Activity – 2.6 Group Activity
    • Selection of audit team.
    • Evaluation of Auditor Competence
    • Activity – 2.7 Group Activity
    • Managing Audit Programme Results / Records / Performance.
    • Activity – Group activity
  • Module 3
    • CONDUCTING AN AUDIT
    • Preparing Audit Activities
    • Contact with Auditee
    • Audit Planning
    • Review Documentation
    • Risk Approach
    • Activity 3.1 - Group Case study : Prepare and effective Audit Planning
    • Audit Tools
    • Audit Documentation
    • Activity 3.2 (True / False)
    • Selection and Confirmation Team of Auditors
    • Conducting Audit Activities
    • Guides and Observers
    • Opening Meeting
    • Activity 3.3 Group Case: Analyze the following “Opening Meeting Material”.
  • Module 4
    • CONDUCTING AN AUDIT-STARTING ACTIVITIES.
    • Audit Process Objective.
    • Audit Execution Process
    • Activity – Calibration of concepts.
    • Collecting and verifying information
    • Methods of collecting information
    • Generating Audit Findings.
    • Activity - Group Case: Collecting information
    • Activity – True or False.
    • Audit Conclusions.
    • Activity – True or False.
    • The “Finding Writing Formula”.
    • Conducting Closing Meeting.
    • Activity - Group Case.
  • Module 5
    • AUDIT CONCLUSIONS , REPORT AND FOLLOW UP.
    • Audit Closing Process and Report Process
    • Closing Meeting
    • Activity – True or False.
    • Report Process
    • Audit Reporting
    • Writing a Non-Conformance
    • Activity – True or False.
    • Audit Follow Up
    • Activity - Group Case study.

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