Audit Planning – How do you prepare?

Speaker: Theresa McCarthy

The first and most important phase of the audit process is planning. In addition to what is covered in ISO 19011, Theresa would like to share some other planning ideas and audit requests you can make in advance. Please bring your thoughts on what audit requests you have made in the planning phase that have worked well.

If you are on the receiving end of the audit process as Auditee we will discuss some ways to get ready and you will have an opportunity to share how you get your facility and employees ready for when “The Auditors Are Coming”.

Theresa left Wang Laboratories in 1992 where she worked as a Training and Development Specialist on the Quality Leadership Process (QLP) and ISO 9002 implementation.

She then conducted the 5-day Lead Auditor Workshop for Perry Johnson Inc. (PJI); performed ISO 9001 registration audits for Perry Johnson Registrar (PJR), and delivered public and on site Information Mapping Inc. seminars.

In 1996 Theresa began delivering the ISO 9001 Collaborative program for Merrimack College. The program organized groups of 5-7 companies to work on ISO 9001 implementation projects. Participants attended six workshops and received two days of on site consulting and training services.

In 2003 Theresa joined Abbott Laboratories as a Senior Compliance Specialist. She conducted internal audits, ISO 17025 audits of product testing laboratories, and worked in the Ready Room to facilitate FDA and Corporate audits.

When Abbott Laboratories closed the Bedford MA location, Theresa joined the Massachusetts Manufacturing Extension Partnership (MassMep) as a Project Manager. Theresa provided training and consulting services to assist small to medium size manufacturers. This included Principles of Lean, Value Stream Mapping, 5S workplace organization and Green and Clean initiatives with the Boston EPA office. Theresa developed and updated quality management systems for Boeing and Automotive suppliers to comply with AS9100B and TS16949.

Theresa returned to industry in 2006 to work as a Senior Compliance Specialist for a Biotech company. Today she conducts internal, external and corporate audits.

Theresa is an RABQSA Lead Auditor and a Granite State Quality Examiner based on Baldrige criteria. Theresa works with professors at the UNH Durham Pollution Prevention program, Southern NH University SNH Quality Management Program and the President of the NH Biotechnology Council.

Cost: $22.00 members; $27.00 non-members; $15.00 retired/unemployed/students

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From the South -- Route 128/95 north. On Rte. 128 North take Exit 27A at the end of the exit ramp turn right at the traffic light onto Totten Pond Road, which is perpendicular to the highway. Proceed one quarter of a mile to the entrance of the second office park on your right (Across from the “Naked Fish” Restaurant). Turn right and proceed up the driveway, and bear left to the hotel entrance.

From the North -- Route 128/95 to Exit 27A. At the end of the exit ramp merge right onto Totten Pond Road, which is perpendicular to the highway. Cross over the highway and proceed one quarter of a mile to the entrance of the second office park on your right. (Across from the “Naked Fish” Restaurant). Turn right and proceed up the driveway, and bear left to the hotel entrance.