Remote Auditing: What To Expect And How To Prepare
Barbara has more than 35 years of experience as a quality professional. She started out in Aerospace/Defense and automotive then added medical device and commercial manufacturing. She was a teacher in the Worcester Public schools and brings that training expertise into the manufacturing environment. She worked as Quality Manager and VP of Quality before starting BQA a Consulting and training company in 1991. She is a trainer at Quality Productivity Solutions and a contract Quality System Lead Auditor for several registrars.
- Quality Professional for more than 35 years
- Quality Services Consultant/Trainer/Auditor over 20 years
- Successful ISO 9001, TS16949, ISO 13485, AS9100 and ISO17025 Registrations
- Lean Six Sigma Black Belt
- RAB /Exemplar auditor
- AS9100 Lead Auditor (certified to Rev C, trained to Rev D) , ISO 13485 Lead Auditor
- ASQ Certified Quality Engineer since 1986; ASQ Certified Quality Auditor since 1988
- Published/Presented papers at ASQ Conferences. Coordinated Conference Programs.
- Two time Section Chair, several other executive board positions Worcester Section ASQ, NEQC
- Certified Instructor ISO 9001 Lead Assessor Training (IRCA, accredited course,)
- Certified instructor QPS Institute. Exemplar auditor ISO 9001,2015 and ISO 13485.2016,
- FDA regulations trainer, 510 and cGMP
- Mil 883 Training package for compliance and workmanship, recommended by DoD personnel
- Elected to Board of Directors, Central Mass, Divisional Rehabilitation Center “Life Skills, Inc.”
- ISO 9001 Lead auditor for several Registrars: URS Virginia office, ACC Massachusetts Office, IMS
- WorldUK and US office. NQA. Supplier Auditor SpaceX accounts SQA services (AS9100, NADCAP)
- QPS Training and consulting
- ISO 13485, FDA topics, AS9100, ISO9001.2015 consulting, implementations, and auditing
- Auditor Trainer, ASQ certification refresher trainer, Green Belt trainer, Risk Management/FMEA, Problem Solving
- Quality Professional, Consultant
- Butrym Associates – Putnam, Ct
- ISO/AS Auditor/Lead Auditor, contract
Millions of US workers work remotely for US-based companies. Internal auditors, procurement engineers, supervisors, and managers are challenged to understand what is occurring in the global supply chain and how to conduct 1st, 2nd and 3rd party audits remotely. Virtual auditing presents a host of benefits to companies for the following reasons:
- Remote auditing replicates the emerging Remote workforce's environment. Auditors need to become more familiar with how to communicate virtually to better understand the communication issues affecting these Remote Quality Management Systems.
- Remote auditing helps to streamline documentation and record control in the Remote environment through reoccurring scheduled reviews. Remote auditing reduces costs and is good for environmental sustainability
This webinar will provide new communication skills and tools to remote team members and quality system auditors who are working remotely.
- Remote team members working in global supply chains
- Managers responsible for personnel working remotely
- ISO 9001/ISO 13485 Internal and External Auditors, AS9100 Internal/External Auditors, OSHA and FDA Auditors
- Company ownership and top management that drives the Regulation requirement
- Senior management, Quality / Operations VPs / Directors, Auditors, and Subcontract Auditors
- Examine the virtual environment
o Define the working environment criteria most likely to benefit from Remote auditing.
o Apply ISO Standard Elements to remote team global supply chain.
o Define what sectors are impacted: Worldwide Supply Chain Management; Manufacturing and Service.
o Choosing your audit criteria/scope and how that affects your audit
- Define the following types of Remote auditing and compare when each is optimum
o Traditional site model.
o Hybrid site model.
o Remote auditing model
- Illustrate how Remote auditing is accomplished
o Collaborative programs – Synchronous communication.
o Offsite document review followed up with TEAMS/Zoom
o Document sharing, video conferencing
- Discuss the benefits for Remote auditing
o Record control and centralization.
o Reduce your onsite hosting workload.
o Understand QMS communication issues associated with working Remote.
o Cost of travel, hidden costs of being away from your work site
- Planning for a remote audit and its challenges
o How to get the most for your time and ensure availability of information and resources
o Examples of plans and how to prepare them
o Tools and techniques /examples and why they work or hinder your audit
o Tips on using ICT and comparison of the different styles and their best applications
Course Level - Intermediate
Who Should Attend
In this session, learners will discuss applicable environments for Remote auditing, the interactive programs used over the Internet, and how to conduct effective remote audits
Why Should You Attend
One third of US-based companies have transitioned their manufacturing virtually to a worldwide supply chain, changing roles from local hands-on to site worldwide companies in Mexico, Europe, Asia, or India to resolve product or process issues. For many of these global teams, managing the worldwide supply chain is the focus, objective, and scope of the dispersed companies’ ISO 9001 certification.
Virtual auditing presents a host of benefits to companies including helping to solve communication issues because Remote auditing will streamline and maintain websites, documentation, and record control in the Remote environment through reoccurring scheduled reviews. Customer portals have become a tool for communication and information sharing.
Auditors need to become more familiar with how to communicate virtually to better understand the communication issues affecting these audits. Quality Systems Auditors were rained to look at visual clues and body language as part of the technique. Often auditors are unaware of how to use collaborative systems for audit purposes, or how to work in teams over the Internet. This session will help auditors gain a better understanding of virtual communication (ICT) to realize the issues affecting these virtual Quality Management Systems.