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This e-Newsletter is in HTML format and may not be displayed properly by some email programs. Please click on our web site address above to see the e-Newsletter with its proper formatting.
The ISO 9001 Auditing Practices Group has 24 papers posted at its section of the ISO web site. This article is an edited version of their paper on Auditing Preventive Action. There is often confusion
on the differences between correction, corrective action, and
preventive action. Correction is the action to eliminate a detected
nonconformity, e.g., reworking or regrading a product so it becomes
conforming. Corrective Action is the action to eliminate the cause
of a detected nonconformity to prevent its recurrence.
Preventive Action is the action
to eliminate the cause of a potential nonconformity to
prevent its occurrence.
b) An evaluation of the need for preventive action. Methods used in the evaluation could include: c) How the organization determines what action is required, and how it is implemented. An auditor should look for evidence that:
d) Records of the results of the actions taken
e) A review of the preventive actions taken
3) There is often significant “philosophical” discussions between the auditor and the organization about where corrective action ends, and where preventive action begins. For example, if a nonconformity is detected in process “A”, are actions taken to avoid future nonconformities in processes “B”, “C”, and “D” preventive actions, or simply within the scope of the corrective actions taken for process ”A”? The auditor should avoid being “side-tracked” by these discussions, and concentrate on whether or not the actions were effective. The “labeling” of the actions taken is of secondary importance! The I SO 9001 Auditing Practices Group includes a disclaimer with the papers that they have not been subject to an endorsement process by the ISO, ISO/TC 176, or IAF organizations. The group also states that the information is available for educational and communication purposes, and that they do not take responsibility for any errors, omissions, or other liabilities that may arise from the provision or subsequent use of such information.
The 25th Annual
Southeastern Quality Conference will be
held
at the Cobb Galleria Centre in Atlanta, Georgia on October 31 -
November 1, 2005.
The
conference is sponsored by the American Society
for Quality (Atlanta Section 1502), Institute of Industrial
Engineers, and Georgia Tech Economic Development Institute. A partial list of the thirty speakers includes:
Beginning this year, a single new ANSI-ASQ National Accreditation Board (ANAB) mark replaced the ANSI-RAB NAP mark on accredited certificates, marketing material, stationery, etc. The transition to the ANAB accreditation mark must be completed by the end of this year. This requirement is described in ANAB "Heads Up" - 41: 1. If new material to replace existing material bearing an ANSI-RAB NAP accreditation mark is produced for use on or after January 1, 2005, the new material shall include the ANAB mark instead of the ANSI-RAB NAP mark. 2. Any existing material bearing an ANSI-RAB NAP accreditation mark shall not be used after December 31, 2005, that is, after a one-year transition period. 3. A registered organization may use the ANAB accreditation mark only in conjunction with the EMS or QMS accredited CB’s mark on the organization’s stationery and literature, and in its advertising, subject to the conditions in this advisory and to the CB’s conditions for use of its mark. 4. The ANAB accreditation mark shall be reproduced: a. in black or in blue (PMS 2935 or equivalent) b. in a size which makes all features of the mark clearly distinguishable. c. without distortion of its dimensions. 5. When using the ANAB accreditation mark, its size must not exceed the size of the CB’s mark. 6. An organization may not place the ANAB accreditation mark in isolation from the CB’s mark. 7. An ANAB accreditation mark shall not be used by an ANAB-accredited CB on any document unless the document relates in whole or in part to registration activities of the CB, which are accredited under the ANAB. This would not preclude an ANAB accredited CB from including the accreditation mark on its preprinted letterhead paper. 8. ANAB’s accreditation mark shall not be used on a product or in such a way as to suggest that the CB and/or ANAB have certified or approved any product, process, or service of a registered organization, or in any other misleading manner. If larger boxes, etc., used for transportation includes the mark(s), a statement must be included. This could be a clear statement that “(This product) was manufactured in a plant whose quality/environmental management systems are certified/registered as being in conformity with ISO 9001, AS9100, ISO 14001 (specific standards)”. To see other Heads Up and Advisories, go to: <http://www.anab.org>.
Since 1988, the U.S. chemical industry, through the American Chemistry Council, has implemented Responsible Care, a voluntary program to achieve improvements in environmental, health, and safety performance beyond the levels required by the U.S. government. The program has resulted in:
Every Responsible Care company is required to certify that a management system has been put in place and must demonstrate progress toward improved performance. To obtain certification, companies undergo headquarters and facility audits conducted by independent, accredited auditing firms. Companies may choose from two certification options: (1) RCMS certification, which verifies that a company has implemented the Responsible Care Management System; or (2) RC14001 certification, which combines RCMS and ISO 14001 into a single, more cost-effective process. All Responsible Care companies are required to have completed headquarters certification by December 31, 2005, and initial facility certification by December 31, 2007. Thereafter, certification will be renewed every three years. A new cycle of certification audits will begin in 2008. A combined certification audit option (Headquarters and Facility Combined Audit) is available only to small companies with headquarters and facilities that are "co-located" or that have headquarters with "minimal" Responsible Care activities. This audit option must be completed by December 31, 2006. The Responsible Care 14001 Management System Technical Specification aligns Responsible Care Codes of Management Practices elements with those from ISO 14001, helping companies to better understand what is needed to meet the requirements of both standards. RC14001:2005 was issued this year to incorporate the changes in ISO 14001:2004. In addition, RC14001:2005 added new security requirements. The EMS has expanded to become an "Environmental, Health, Safety, and Security" Management System. Responsible Care organizations must now perform security vulnerability assessments to consider the intentional or willful impact to the environment, health, or safety. To order single user copies (Product ID# 610474D), call ACC's Store at 301-617-7824 or order online under Software-Responsible Care. For multi-user or multi-site copies, call ACC's Publications Manager at 703-486-2992. The Responsible Care 14001 Management System Technical Specification (RC14001) also readily permits accredited registrars to evaluate a company’s system against both sets of requirements in a single audit process, issuing a special Responsible Care ISO 14001 certificate. For more information, go to the ACC web site at <http://www.americanchemistry.com> and the RC web site at: <http://www.responsiblecare-us.com>.
ISO 10005:2005 provides guidelines for the development, review, acceptance, application, and revision of quality plans. It is applicable whether or not the organization has a management system in conformity with ISO 9001. ISO 10005:2005 applies to quality plans for a process, product, project, or contract, as well as, any product category (hardware, software, processed materials and services) and any industry. It is focused primarily on product realization and is not a guide to organizational quality management system planning. You can order an e-Standard version of ISO 10005:2005 at the ANSI
web site by clicking
here. The price is $81.00.
ISO 22000:2005, "Food safety management systems – Requirements for any organization in the food chain", is intended to allow all types of organizations within the food chain to implement a food safety management system. These organizations range from feed producers, primary producers, food manufacturers, transport and storage operators and subcontractors to retail and food service outlets, as well as, related organizations such as producers of equipment, packaging material, cleaning agents, additives, and ingredients. This new standard has become necessary because of the significant increase of illnesses caused by infected food in both developed and developing countries. In addition to the health hazards, food-borne illnesses can give rise to considerable economic costs covering medical treatment, absence from work, insurance payments, and legal compensation. Developed with the participation of food safety experts, ISO 22000 incorporates the principles of HACCP (Hazard Analysis and critical Control Point) system for food hygiene. Food safety management systems that conform to ISO 22000 can be certified although the standard can be implemented without certification of conformity, solely for its benefits.While ISO 22000 can be implemented on its own, it is designed to be fully compatible with ISO 9001:2000 and companies already certified to ISO 9001 will find it easy to extend this certification to ISO 22000. To help users, ISO 22000 includes a table showing the correspondence of its requirements with those of ISO 9001:2000. ISO 22000:2005 is the first in a family of standards that will include:
Classes taught by Larry Whittington are shown in yellow.
ISO
9001:2000 Lead
Auditor (RABQSA Certified) - BSI Management Systems
ISO
9001:2000
Internal Auditor (RABQSA Certified) - BSI
Management Systems
Quality System Documentation (ISO 9001:2000) Course developed by Larry Whittington
The above public courses can be offered on-site at your facility. In addition, we offer these on-site courses:
© 2000-2005 Whittington & Associates, LLC. All rights reserved. You may copy this e-Newsletter provided you copy it completely, do not change it, and include this copyright notice. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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