3-Day API Q1 10th Edition Auditor Training
Days: 3 • CEU Hrs: 2.4
Time: Day 1 7:30 a.m. – 4:30 p.m.
Day 2 7:30 a.m. – 4:30 p.m.
Day 3 7:30 a.m. – 4:30 p.m.
Overview
This course prepares you to perform internal QMS audits using industry-proven techniques and to apply proper interpretation of the API Q1 standard to real life audit situations. You’ll follow the full audit process including: audit tools and preparation, opening meetings, audit interviews, closing meetings, and reporting.
This is a very practical class that is not “bogged-down” with academic discussions of quality topics that have limited utility for class attendees.
This Internal Audit class makes extensive use of activities and case studies to help you fully understand the requirements of quality system auditing to the API Q1 10th Edition. Since people “lock” new understanding into long-term memory much better when they apply it, lecture time is held to a minimum providing you time to grasp and then practice your newly acquired skills in simulated real-life audit situations.
Who Should Attend
Individuals who will perform audits to API Q1 or Quality Management Systems, individuals assisting their organizations toward API registration, or individuals who are frequently audited should attend this training. Quality directors, managers, engineers, auditors, ISO coordinators, laboratory quality professionals, and anyone engaged in quality audits will benefit from this training.
Prerequisites
There are no required prerequisites. This course is routinely taught to quality novices and life-time professionals. All attendees are required to bring their own copy of the API Q1 10th Edition to this training course- These will not be provided for you. We strongly advise you bring a “paper” copy.
API Q1 Course Objectives
- Prepared to conduct a solo internal audit at successful course completion.
- Fully understand and interpret the API Q1 requirements.
- Apply the proper interpretation of the standard in actual audit situations.
- Understand process auditing tools leading to substantive quality system improvements.
- Tailor an audit interview based on the requirements of the standard and obtain audit evidence from this interview.
- Follow-up and resolve “audit trails that present themselves during the audit interviews.
- Conduct audits that result in real improvements to the quality system.
- Plan and execute the entire audit process including: audit preparation, opening meetings, auditing, closing meetings, and reporting.
Agenda
Day 1
Part | Topic | Length |
1 | Introduction | :30 |
2 | Terminology & Purpose
Special Notes, purpose, significant changes from 9th to 10th edition, QMS process map, turtle diagrams, process effectiveness & KPI’s.
|
:45
:60 |
3 | Review Standard Requirements
Plan-do-check-act, in-depth review of standard, Clause 4/Clause 5, PFMEA, Design Validation, ‘V’ model, phase review, V&V matrix, supplier evaluation form, purchase order, certificate of analysis, production traveler, final QC, NC matrial, Clause 6, audit schedule, corrective actions and RCA, management review, API monogram program and Annex A.
|
3:30
:30 |
7.25 Hours |
Day 2
Part | Topic | Length |
3 | Applying the Standard
|
:90
:60 |
4 | Auditing to ISO 19011
Auditor attributes, knowledge and skills, team leader, audit client, auditor, auditee, management representative, guide, varying audit objectives, types of audits, audit checklist, audit feedback.
|
:90
:30 |
5 | Audit Execution
Audit process overview, document reviews, preparing audit plans, performing audit activities. |
:60 |
6.5 Hours |
Day 3
Part | Topic | Length |
5 | Audit Execution
Opening meetings, audit communications, audit findings, major/minor, OFI’s, interviewing auditees, questioning techniques, active listening, questioning methods, auditor feedback, writing nonconformity statements, audit debrief
|
:90
:40 |
6 | Audit Reporting/Corrective Actions
Corrective action follow-up, class insights |
:45 |
Internal Auditor Exam | :60 | |
7.25 Hours |