3-Day API Q1 10th Edition Internal 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 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.

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. Activity #1: Quality terminology	: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. Activity #4.4.3: Risk ranking Activity #5.3: Engineering change order Activity #6.4.2: Corrective action	3:30 :30 :30 :30
	7.25 Hours

Day 2

Part	Topic	Length
3	Applying the Standard Activity #2: Audit case studies	: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. Activity #3: Prepare audit checklist Activity #3a: Perform in-class mock audit	:90 :30 :60
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 Activity #4: Mock audit preparation Activity #5: Audit checklist preparation Activity #6: Review audit evidence Activity #7: Perform audit Activity #7a: Audit debrief Activity #8: Writing NC statements	:90 :40 :30 :20 :60 :30 :60
6	Audit Reporting/Corrective Actions Corrective action follow-up, class insights	:45
	Internal Auditor Exam	:60
	7.25 Hours

Date/Registration