Achieving Effectiveness and Compliance

Transcription

1 Achieving Effectiveness and Compliance Paul Palmes Business Standards Architects, Inc. Fargo ND Prescott, WI I-29 Manufacturers Conference Thursday, September Swiftel Center Brookings SD

2 This is Not your Fathers ISO 9001 The ISO 9001:2008 standard is most often considered to be a requirements document. However, the standard now Requires Effectiveness to be defined and/or confirmed in 18 separate places within the standard! This workshop will examine Effectiveness Sections in an additive manner to help attendees to understand and appreciate the interdependence and logic of ISO s approach to balancing compliance and effectiveness to create a world-class approach to managing your company.

3 ISO 9001:2008, section General requirements The organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard. The organization shall a) determine the processes needed for the quality management system and their application throughout the organization b) determine the sequence and interaction of these processes, c) determine criteria and methods needed to ensure that both the operation and control of these processes are effective, d) ensure the availability of resources and information necessary to support the operation and monitoring of these processes, e) monitor, measure (where applicable), and analyze these processes, and f) implement actions necessary to achieve planned results and continual improvement of these processes.

4 ISO 9001:2008, section 4.1 (In every day language) The Heart and Soul of the standard: 1. What are your processes? 2. How are they interconnected? 3. What criteria is used to measure each for effectiveness? 4. Provide resources to allow them to function well 5. Monitor and measure their performance 6. Take action to achieve planned results

5 Take Action?! 5. Monitor and measure their performance (From 4.1) 6. Take action to achieve planned results ISO 9001:2008, section 8.2.3: Monitoring and measurement of processes The organization shall apply suitable methods for monitoring and, where applicable, measurement of the quality management system processes. These methods shall demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, correction and corrective action shall be taken, as appropriate.

6 ISO 9001:2008, section Monitoring and measurement of product The organization shall monitor and measure the characteristics of the product to verify that product requirements have been met. This shall be carried out at appropriate stages of the product realization process in accordance with the planned arrangements (see 7.1). Evidence of conformity with the acceptance criteria shall be maintained.

7 ISO 9001:2008, section (In every day language) In ISO-Speak, Process outputs are Products World-Class companies regularly report Major process Performance to Defined Goals (their Products!) to Management Quote Hit Rate Sales/Estimating Scrap and Rework Production Project Timeliness Design Minutes on Hold Customer Service

8 ISO 9001:2008, section The organization shall conduct internal audits at planned intervals to determine whether the quality management system: a) conforms to the planned arrangements (see 7.1), to the requirements of this International Standard and to the quality management system requirements established by the organization, and b) is effectively implemented and maintained. An audit program shall be planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits. The audit criteria, scope, frequency and methods shall be defined. This selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process. Auditors shall not audit their own work There it is, Again!

9 ISO 9001:2008, section An Effective Approach to Scheduling Internal Audits Weekly Directors Meetings Guide program and receive results of audits performed Audit Candidates Problem Area Identified Audit Schedule: Performed monthly Quarterly Board Meetings Guide program and receive results of audits performed Answers and Improvement Problem Area Audits Focused efforts Corrective Action Program

10 (see 7.1) Product Realization They re Connected! 7.1 Planning of product realization ( What s required of Each Process? ) The organization shall plan and develop the processes needed for product realization. Planning of product realization shall be consistent with the requirements of the other processes of the quality management system (see 4.1). In planning product realization, the organization shall determine the following, as appropriate: a) quality objectives and requirements for the product; ( Characteristics ) b) the need to establish processes and documents, and to provide resources specific to the product; (Resources: Methods, Tools and People) c) required verification, validation, monitoring, measurement, inspection and test activities specific to the product and the criteria for product acceptance; (Testing scheme to Determine if we re Achieving Planned Arrangements) d) records needed to provide evidence that the realization processes and resulting product meet requirements (Proving we ve achieved Planned Arrangements) The output of this planning shall be in a form suitable for the organization's method of operations.

11 World Class Performance Flowchart your Major Processes Assign Goals/Objectives to each Process Regularly Monitor and Report Status to Management Assign Resources as needed to Achieve Assigned Goals/Objectives Improve upon Achieved Goals/Objectives Repeat, Repeat..

12 Best of Success, and Thank you!!

13 Paul Palmes is principal consultant with Business Systems Architects, Inc., Fargo, North Dakota and Prescott, WI. Working as a specialist in quality management and world-class quality systems over the past 27 years, he has enabled many organizations to attain ISO 9001 registration and many others to improve profitability and culture. He is a senior member of the American Society for Quality, a Certified Quality Manager and BSI Certified Lead Auditor. He is an active Podcaster with world-wide listeners through his Quality 101 program series at His many publications include two books, Process Driven Comprehensive Auditing, and The Magic of Self Directed Work Teams, published by ASQ Quality Press, and articles written for ASQ s Quality Progress magazine and The Auditor Newsletter, published by Paton Press. He maintains membership within the Steering Committee of the Open Compliance and Ethics Group (OCEG), developing fully integrated ethics and compliance guidelines for US public corporations. Currently a member of the US TAG to ISO TC 176, he held positions as Vice Chair and Membership Chair from 1997 to 2010 and represented the United States as lead delegate and working group secretary in the development of international guidance standard, ISO Quality Management Systems: Realizing Financial and Economic Value. During this period, he also served as US TAG representative and International TC 176 Liaison to the IAF and co Chair of the IAF s ISO 9000 Advisory Group, a member of the Auditing Practices Group (APG), and the Quality Council of the ANSI/ASQ National Accreditation Board (ANAB). He is currently Head of Delegation for SC 1 within the US TAG. pcpalmes@cableone.net Telephone: