0 | Unique Visitors |
Author Archive
March 31st, 2010 | 
Author: 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.
Working as a QMS Lead Auditor for numerous international ISO registrars, I assessed numerous big multi-facility organizations that had difficulties with synchronizing their home office ISO 9001 quality manuals with the corresponding documents controlled by their sites. Designing quality manuals for companies with multiple sites, organizations develop their sites’ quality manuals as copies of the corporate quality manual; other enterprises create facility-specific manuals that are totally autonomous and do not correlate with the corporate ISO 9001 manuals.
In the first case, when a site-specific quality manual is a copy of the corporate manual with modifications specific to a given site, mechanisms to keep these documents coordinated are rarely defined. Difficulties of keeping these documents in sync are due to the fact that corporate quality manuals are controlled by the home office, while local quality manuals are responsibility of site’s documentation control departments.
In the case of the second approach, when organizations allow their satellite locations to have their own quality manuals independent from the corporate manual, differences in quality manuals may create major disconnect of the corporate and local ISO 9001 quality manuals.
If an organization wishes to deliver a consistent message regarding its quality policies, the deficiencies of discussed methods become obvious.
One of our large customers demonstrated this point well. The corporate ISO 9001 quality manual addressed majority of the requirements of the standard and referenced appropriate regulations. At the same time, one of their US locations did not reference required ISO 13485 standard, Mexico facility missed a commitment to compliance with regulatory requirements, yet Costa Rica site failed to document their ISO 9001 quality policy 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,
This model proved to be effective for a single-location company. This approach will also work for a multi-site business, but only for common documents that are used at all locations. For example, such procedures as Internal Audit, Management Review, Corrective and Preventive Action, and others may be the same for your all facilities and therefore be referenced in the quality manual as shown above.
While references to common procedures in an ISO 9001 quality manual are clear, we still have to address those documents that are specific to particular locations such as incoming inspection, org charts, product verification and others. When we wish to maintain just one quality manual, we need to reference in it supporting procedures for all sites which may easily clutter the manual. To solve this problem we will examine how a common quality manual can efficiently reference facility-specific procedures to address statements of the organization’s 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.
If we need to work with a company that has significant number or offices and wishes to reference in the quality manual procedures controlled by its sites, we may take a different approach. For example, we can prepare a matrix to associate the corporate quality manual clauses with the site-specific procedures. We can name this tool Manual Reference Matrix and consider the following reference model:
Corporate ISO 9001 Quality Manual section
Manual Reference Matrix Table of Contents (ToC)
Site-specific Manual Reference Matrix
Location-specific procedure
Our Manual Reference Matrix ToC is simply a list of company’s locations or sites’ Manual Reference Matrixes, as shown in the illustration below:
Manual Reference Matrix Table of Contents
Main Office (Washington, DC USA)
Toronto (Canada)
Cleveland, OH (USA)
Buenos Aires, (Argentina)
Portland OR USA
etc,
Let’s see how this model works. We will document element 8.4, Analysis of data: Sunrise, LLP has established and maintains documented Management Review Procedure and site-specific data analysis procedures per the Manual Reference Matrix ToC to determine, collect and analyze appropriate data to determine the suitability and effectiveness of the Quality Management System to evaluate areas where continual improvements of the effectiveness of the ISO 9001 QMS can be made This element states that the company uses common Management Review Procedure and site-specific data analysis procedures. To locate a site-specific data analysis procedure, we simply need to consult the Manual Reference Matrix ToC.
Finding the location in the Matrix ToC and locating, let’s say, St. Petersburg’s Matrix, we will identify a site-specific Manual Reference Matrix. Locating a specific element in the location’s Manual Reference Matrix, we will find a particular, location-specific procedure title that addresses our clause.
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.
If you are developing an ISO 9001 quality manual for a large corporation with multiple sites, check the links below for samples of Quality Manual Reference Matrix.
If you are developing an ISO 9001 Quality Manual for a company with multiple locations 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 and documentation sets.
Posted in 
Tags: 
Since introduction of ISO 9001 Standard for quality management systems the market has developed numerous practical models of quality manuals for organizations with single sites. At the same time, formats for management system structures for multi-facility businesses are limited at best in technical publications. This paper discusses a model for structuring a top-level documentation that allows an organization with multiple sites to use common ISO 9001 quality management system manual. Discussed approach noticeably improves consistency of the organization’s quality policies.
Through my work as a Lead Auditor with major registrars, I observed dozens of large multi-location companies struggling with connecting their corporate ISO 9001 quality manuals with the supporting, location-specific, documents. To develop a quality manual for a company with numerous facilities, organizations take two routes. Some organizations create site-specific quality manuals as copies of the corporate manual; others create site-specific ISO 9001 quality manuals that are entirely different from the corporate manual.
In reality, these solutions do not provide for a consistent representation of the organization’s position on quality. The first approach, when a copy of the home office quality manual is used, techniques for controlling local quality manuals are usually not determined. Differences in the corporate manual and the site’s quality manual are because the corporate office manuals are managed by the home office, while site’s manuals are controlled by individual sites.
In the case of the second approach, when organizations allow their satellite locations to have their own quality manuals independent from the corporate manual, differences in quality manuals may create major disconnect of the corporate and local ISO 9001 quality manuals.
If an organization wishes to deliver a consistent message regarding its quality policies, the deficiencies of discussed methods become obvious.
As an example, we can examine one of our international clients with facilities in the United States, Mexico and Europe. This organization established pretty complete quality manual for their corporate office in the US. When we visited their plant in Mexico, we found that their quality manual did not include reference to Canadian regulations; the facility in Italy did not address the design process, etc.
As one can see, both approaches above to development of site quality manuals as copies of the corporate manuals or independent quality manuals do not appear to be practical or economical.
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.
As with a single-location company, a business can still use the same reference structure if the number of locations or sites is small; let’s say not to exceed three. For example, element 8.5.1 Continual improvement, may read: Yellow Submarine Company has established and maintains documented procedures to continually improve its QMS through the use of its Quality Policy, Quality objectives per the Quality Objectives Matrix HO and the Quality Objectives Matrix BA This example references the common Quality Policy and site-specific Quality Objectives Matrix HO (Home Office) and Quality Objectives Matrix BA (Buenos Ares). This model serves well quality management systems with limited number of facilities, but it becomes ineffective when the number of company’s locations increases.
For companies with a large number of locations, where we need to reference numerous documents in the manual, including those controlled by satellite locations, we have another option. We can establish a document to connect corporate quality manual commitments with the site-specific supporting documents. Let’s name this document a Manual Reference Matrix and consider the following document reference structure.
Corporate ISO 9001 Quality Manual clause
Manual Reference Matrix Table of Contents (ToC)
Location Manual Reference Matrix
Location-specific procedure
We will structure our Manual Reference Matrix as a list of all facilities and their corresponding Manual Reference Matrixes, as shown below:
Manual Reference Matrix Table of Contents
Home Office (Denver, Colorado, USA)
Millburn (Australia)
St. Petersburg (Russia)
Lima (Peru)
Port Williams (Chile)
etc,
Let’s see how this model works. We will document element 8.4, Analysis of data: Sunrise, LLP has established and maintains documented Management Review Procedure and site-specific data analysis procedures per the Manual Reference Matrix ToC to determine, collect and analyze appropriate data to determine the suitability and effectiveness of the Quality Management System to evaluate areas where continual improvements of the effectiveness of the ISO 9001 QMS can be made This element states that the company uses common Management Review Procedure and site-specific data analysis procedures. To locate a site-specific data analysis procedure, we simply need to consult the Manual Reference Matrix ToC.
Finding the location in the Matrix ToC and locating, let’s say, St. Petersburg’s Matrix, we will identify a site-specific Manual Reference Matrix. Locating a specific element in the location’s Manual Reference Matrix, we will find a particular, location-specific procedure title that addresses our clause.
A Manual Reference Matrix may be formatted as a three-column form. The first two columns are titled Corporate Manual Section No. and Corporate References; the third column is called Location references. For the element 5.5.1, for example, the Matrix indicates that our manual references Organizational Chart HO for the corporate office and the Organizational Chart Ontario for the Ontario facility.
If you are developing an ISO 9001 quality manual for a large corporation with multiple sites, check the links below for samples of Quality Manual Reference Matrix.
Since introduction of ISO 9001 Standard for quality management systems the market has developed numerous practical models of quality manuals for organizations with single sites. At the same time, formats for management system structures for multi-facility businesses are limited at best in technical publications. This paper discusses a model for structuring a top-level documentation that allows an organization with multiple sites to use common ISO 9001 quality management system manual. Discussed approach noticeably improves consistency of the organization’s quality policies.
Working as a QMS Lead Auditor for numerous international ISO registrars, I assessed numerous big multi-facility organizations that had difficulties with synchronizing their home office ISO 9001 quality manuals with the corresponding documents controlled by their sites. Designing quality manuals for companies with multiple sites, organizations develop their sites’ quality manuals as copies of the corporate quality manual; other enterprises create facility-specific manuals that are totally autonomous and do not correlate with the corporate ISO 9001 manuals.
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.
In the case of the second approach, when organizations allow their satellite locations to have their own quality manuals independent from the corporate manual, differences in quality manuals may create major disconnect of the corporate and local ISO 9001 quality manuals.
Those companies that adhere to the policy of maintaining a consistent corporate message regarding their position on quality will definitely experience a gap if they use methods that we discussed above.
One of our large customers demonstrated this point well. The corporate ISO 9001 quality manual addressed majority of the requirements of the standard and referenced appropriate regulations. At the same time, one of their US locations did not reference required ISO 13485 standard, Mexico facility missed a commitment to compliance with regulatory requirements, yet Costa Rica site failed to document their ISO 9001 quality policy all together!
Summarizing my consulting experiences, I am convinced that these approaches to design of the corporate quality manual and sites’ manuals do not provide a solid consistent way to document organization’s quality manuals.
To solve this problem, let’s review an ISO 9001 quality manual model, specifically supporting document reference structure. As a common practice, a quality manual references supporting documents within the text of the manual. For example, clause 5.5.1 of the quality manual, Responsibility and authority, may read: 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 the Organizational Chart.
This method of referencing supporting procedures is very common for quality manuals for companies with single location. Interestingly, it also works for a multi-site business for those documents that are common for all sites. For instance, Audit Procedure, CAPA Procedure, and others may be the common for your all sites and be referenced in your quality manual as demonstrated in previous paragraph.
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.
As with a single-location company, a business can still use the same reference structure if the number of locations or sites is small; let’s say not to exceed three. For example, element 8.5.1 Continual improvement, may read: Yellow Submarine Company has established and maintains documented procedures to continually improve its QMS through the use of its Quality Policy, Quality objectives per the Quality Objectives Matrix HO and the Quality Objectives Matrix BA This example references the common Quality Policy and site-specific Quality Objectives Matrix HO (Home Office) and Quality Objectives Matrix BA (Buenos Ares). This model serves well quality management systems with limited number of facilities, but it becomes ineffective when the number of company’s locations increases.
For companies with a large number of locations, where we need to reference numerous documents in the manual, including those controlled by satellite locations, we have another option. We can establish a document to connect corporate quality manual commitments with the site-specific supporting documents. Let’s name this document a Manual Reference Matrix and consider the following document reference structure.
Corporate ISO 9001 Quality Manual section
Manual Reference Matrix Table of Contents (ToC)
Location Manual Reference Matrix
Facility-specific document
We will structure our Manual Reference Matrix as a list of all facilities and their corresponding Manual Reference Matrixes, as shown below:
Manual Reference Matrix Table of Contents
Main Office (Washington, DC USA)
Toronto (Canada)
Jacksonville, IL (USA)
Lima (Peru)
Portland OR USA
etc,
To show how this approach works, we will document element 6.2.1, Human resources, general: Your Company, Inc.’s Management ensures that personnel performing work that affects quality of product are competent on the basis of appropriate education, training, skills and experience per the Resource Management Procedure and facility-specific training procedures per the Manual Reference Matrix ToC. This clause indicates that the organization uses the corporate Resource Management Procedure and facility-specific training procedures. To locate a facility-specific training procedure, one simply needs to go to the Manual Reference Matrix ToC.
Finding the location in the Matrix ToC and locating, let’s say, St. Petersburg’s Matrix, we will identify a site-specific Manual Reference Matrix. Locating a specific element in the location’s Manual Reference Matrix, we will find a particular, location-specific procedure title that addresses our clause.
A Manual Reference Matrix may be formatted as a three-column form. The first two columns are titled Corporate Manual Section No. and Corporate References; the third column is called Location references. For the element 5.5.1, for example, the Matrix indicates that our manual references Organizational Chart HO for the corporate office and the Organizational Chart Ontario for the Ontario facility.
If you are developing an ISO 9001 quality manual for a large corporation with multiple sites, check the links below for samples of Quality Manual Reference Matrix.
