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Business Management Quality Control - Common ISO 9001 Manuals for large corporations.
Business Management Quality Control - Common ISO 9001 Manuals for large corporations.
| Quality Control - Common ISO 9001 Manuals for large corporations. |
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| Written by Mark Kaganov |
| Tuesday, 10 March 2009 07:44 |
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Small and medium size businesses with a single location that utilize ISO 9001 quality management system have developed solid models for the top level documentation. At the same time, information on quality manuals for multi-facility companies was not addressed in professional publications. This publication proposes a model of a quality manual for establishing the top-level documentation structure that allows a business with more than one site to use common ISO 9001 quality management system manual. As a professional QMS assessor with leading certification organizations, I audited many large multi-site enterprises that had problems with aligning their corporate ISO 9001 quality manuals with the supporting documents issued by their locations. To fill this gap, some companies create quality manuals for their locations as copies of the main quality manual; other businesses develop location-specific quality manuals that are completely independent form the home office quality manual. In practice, neither one of these approaches result in a consistent result. In the 1st instance when a modified quality manual is used for a location, methods for updating local quality manuals are not defined. This disconnect arises from the fact that the corporate office manuals are controlled by the home office, while local quality manuals are facilities' responsibility. The 2nd approach, when companies choose their sites to establish their own quality manuals, differences in all those quality manuals lead to noticeable disconnect between the corporate and site-specific quality manuals. From the corporate identity and simply business consistency points of view, an organization should not find itself in a position of having different or conflicting commitments of its facilities to quality, customer satisfaction, design approaches and other requirements of ISO 9001 standard. One of Quality Works' clients illustrated this deficiency. The home office manual documented majority of the applicable requirements. At the same time, one of their Mexico facilities did not reference required ISO 14001 standard, another missed a commitment to customer satisfaction, yet the third one forgot to document their training program all together! As we can see, both approaches to creation of location's ISO 9001 quality manuals as copies of the corporate manuals or independent manuals do not appear to be practical. Besides, if a company has already spent time on developing a quality manual, why should another employee in the same organization spent more time to create a similar or duplicate document? Fortunately, there is a solution. Let's review an example of ISO 9001 2008 quality manual model that references procedures. Our quality manual references supporting documents within the text of the manual. For example, element 4.2.1, Documentation requirements, general, may read: Your Company, Inc.'s QMS documentation includes: documented statements of the quality policy per the Quality Policy and quality objectives per the Key Indicator Matrix, The same method will also work for a multi-site organization for those documents that are used at all locations. For example, such processes as Management Review, NC-CAPA Procedure, Documentation Management Procedure, Audit Procedure, and others may be the same for all locations and therefore be referenced in the quality manual as shown above. However, what if our locations need to use different organizational charts, product realization procedures, and other site-specific quality management system documents? If we use the model above and want to keep a common ISO 9001 quality manual, we have to reference in the manual corresponding documents for all locations which may not be practical. Below we will explore how a corporate quality manual can practically reference location-specific documents to support commitments of the company's common ISO 9001 quality manual. A method identical to a single-site organization can be used when the number of facilities is relatively small, let's say 2 - 3. For example, clause 5.2, Customer focus, of our ISO 9001 quality manual may state: Your Company, Inc's Management Team ensures that customer requirements are determined and met with the objective of enhancing customer satisfaction per the Design Management Procedure, Contract Review Procedure HO and the Contract Review Procedure SP. This example references to the common Design Management Procedure and facility-specific Contract Review Procedure HO (Home Office) and Contract Review Procedures SP (St. Petersburg). This approach works well for a company with limited number of locations, but it becomes unworkable when the number of facilities grows. When an enterprise has significant number of facilities and needs to reference in its manual numerous procedures including those controlled by its sites, we have another choice. We can develop a matrix to connect our quality manual elements with the location-specific supporting documents. We will title this document a Manual Reference Matrix and establish the following documentation reference structure. Corporate ISO 9001 Quality Manual clause Manual Reference Matrix Table of Contents (ToC) Location Manual Reference Matrix Corresponding site-specific document The Manual Reference Matrix is simply a list of all facilities and their Manual Reference Matrixes, as shown below: Manual Reference Matrix Table of Contents Corporate Office (Salt Lake City, UT USA) Millburn (Australia) Jacksonville, IL (USA) Guanajuato (Mexico) Portland OR USA etc, To illustrate this model, let's document element 5.5.1 of our corporate ISO 9001 quality manual with references to site-specific organizational charts: QW Enterprises, LLP's Management Team ensures that the responsibilities and authorities are defined and communicated within the organization per the Resource Management Procedure and site-specific Organizational Charts per the Manual Reference Matrix ToC. This statement tells us that the company uses common Resources Management Procedure and site-specific organizational charts. To locate a site-specific organizational chart, we need to refer to the Manual Reference Matrix Table of Contents (ToC). Clicking the hyperlink Ontario (Canada), for example, we will find a site-specific Manual Reference Matrix. Locating a specific element in the location's Manual Reference Matrix, we will find a particular, location-specific document that corresponds with this clause of out ISO 9001 quality manual. Quality Manual Reference Matrix may be formatted as a three-column table with the Manual Clause in the first column, HO References in the second and Location References in the third column. For example, for the element 8.4, Data Analysis, the Los Angeles plant's Matrix indicates that the manual references Data Analysis Procedure HO for the corporate office and Data Analysis Procedure LA for the Los Angeles plant. Looking for samples of a quality Manual Reference Matrix for ISO 9001 QMS? Check links below. About the Author: If you are tuning up your ISO 9001 Quality Manual for a large corporation and wish to keep your documentation simple, check our Quality Assurance Manual Reference Matrix. If you have questions or need help with implementation of your Corporate Manual, check our Quality Management ISO 9001 consulting services Kindly provided by MoneyHunter.org You are welcome to use this article on your own website, if you include the link just before this text. |
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