The International Standard Organization (ISO) has always known that there is a definite relationship between Process Planning and Process Auditing. They connected those two activities in ISO 9001:2000. The manufacturers, of course, had to plan the Process Flow for a product from “Input” to “Output”. In general, the Internal and Third Party Auditors did not audit the Process Flow as directed in ISO 9001:2000 and ISO 9001:2008. The Auditors audited mainly for compliance with the Standard.
The changes from ISO 9001:2000 and ISO 9001:2008 are relatively minor, but they have reinforced the requirement for a manufacturing process flow. The financial meltdown of 2008 had a significant influence on the traditional compliance based auditing techniques in identifying the risks being taken within the management systems and the individual processes. The Internal and Third Party Auditors were mostly concerned with compliance auditing and they missed the assessment of effectiveness of a process. The aim of introducing Clause 4.1 wanted the Auditor to audit the effectiveness of the process as well as compliance with the requirements in the Standard.
The ISO 9001:2008 stated in the Quality Management System Requirements, Clause 4.1 a) through f) that: “The organization shall establish, document and maintain a Quality Management System and continually improve the effectiveness in accordance with the requirements of this International Standard.”
The major shift towards process management and away from procedural compliance requires a completely different approach when it comes to auditing. It requires a significant change in the competence of the auditor to audit process management effectively.
Managers are playing a significant role in the audit process. They have to identify the key processes with the support processes for any manufactured product; identify the process owner; set the performance objectives and monitor the process for improvements.
A process is defined as a series of joined-up activities that convert inputs into outputs.
Management identifies what processes the organization needs. The process flow charts define the activities the organization is required to follow and fulfill customer needs.
To manage a process effectively, the organization needs to plan, monitor, measure and record the output. The output of the process is compared to the management desired objective. That determines if the process is effective or not.
An experienced Auditor can start his audit at any point in the product flow and he can audit in either direction of the Process Flow, as long as he audits the whole process.
To emphasize again: Plan your process, monitor, measure and identify areas for Process Flow effectiveness and search for improvements.
Bio:
Dr. Hein was a RABQSA certified ISO 9001:2000 and ISO 13485:2004 Lead Auditor and AS9100, Rev B Aerospace Industry Experienced Auditor from the creation of the series until 2006. He is RABQSA certified Instructor and IRCA Certified Aerospace Principal Auditor. He designed and is teaching ISO 13485:03, AS9100, Rev B and AS9110:03 RABQSA approved courses. Dr Hein established the EDUCATIONAL CONCEPTS, INC. (ECI) in 1996 after retiring from the Federal Government as a Professor and Director of the DOD Defense Systems Management College, Defense University. The vision of Educational Concepts is to teach, consult, and assess private businesses; federal, state, and local governments, community colleges and universities. The teaching, consulting and assessing include: Quality Systems Management for ISO 9001, AS9100, AS9110, ISO 13485, 21 CFR 111 and 21 CFR 820 Internal Auditor and Project Management students. The Aerospace Courses are RABQSA approved and the ISO 13485 Course is Registrar approved.
Dr. Hein has 49 years of experience in industry and academia. He is helping businesses to develop effective strategic and business plans, which are based on Quality Management System in design, development, testing, marketing and lean manufacturing principles. Process Management and process auditing have become the leading management tools for Continuous Improvement. Dr. Hein presents classes and workshops at Registrars, in industries and for internal auditors anyplace USA or around the world.