Current Practices Create Inconsistencies

Through my work as a lead auditor with major registrars, I watched dozens of large companies with multiple locations struggling to connect their corporate policies and manuals with supporting location-specific documents. To develop a manual for a company with numerous facilities, organizations take two paths. Some companies create site-specific manuals, either as copies of the corporate manual or site-specific manuals that are different from the corporate manual.

In the former case, where a site-specific manual is a copy of the corporate manual with modifications specific to a given site, mechanisms to keep these documents coordinated are rarely defined and followed. The difficulties in keeping these documents synchronized are due to the fact that the corporate manuals are controlled by the parent company, while the local manuals are the responsibility of the site’s documentation control departments.

Another approach that organizations take is to allow their satellite locations to have their own quality, environmental, or other policies and manuals, separate from the corporate policy and manual. This technique very often leads to a great disconnection from corporate and local policies and manuals. From the standpoint of corporate identity and simply business consistency, an organization should not find itself in a position where its facilities have different or conflicting commitments to quality, environmental issues, customer satisfaction, risks of safety and other requirements of applicable standards. One of our big clients demonstrated this point well. The corporate quality policy and manual addressed most of the requirements of the applicable standards and referenced the corresponding regulations. At the same time, one location failed to reference the required ISO 13485 standard, another failed to make a commitment to meet regulatory requirements, and yet another failed to document their quality policy as a whole!

As we can see, both approaches to creating location manuals such as copies of corporate manuals or stand-alone manuals do not appear to be practical. Furthermore, if a company has already spent time developing a manual, why should another employee in the same organization spend more time creating a similar or duplicate document?

Corporate manuals can be used by all locations

To address this issue, let us review, as an example, the ISO 9001 quality manual template, which specifically supports the document reference structure and application clause. As a common practice, a manual references supporting documents within the text of the manual. For example, clause 5.5.1 of the manual, Responsibility and authority, may say:

The QW Enterprises, LLP management team ensures that responsibilities and authorities are defined and communicated within the organization as per the Resource Management Procedure and Organizational Chart.

The same model will also work for a multi-site organization for those documents that are used across all locations. For example, processes such as Management Review, NC-CAPA Procedure, Document Management Procedure, Audit Procedure and others may be the same for all locations and are therefore referred to in the quality manual as shown above. However, what if our locations have different exclusions, use their own organization charts, product realization procedures, and other site-specific documents? If we use the above model and want to maintain a common manual, we should reference the corresponding documents in the manual for all locations that may not be practical.

Next, we will explore how a corporate handbook can practically reference location-specific documents to support the commitments of the common company handbook. Let’s start by referring to the documents. The same referral structure as for a single location company can be used if the number of locations is small, say two or three. In this case, clause 5.5.1 of our corporate manual may indicate:

The QW Enterprises, LLP management team ensures that responsibilities and authorities are defined and communicated within the organization per the Resource Management Procedure, HO Organizational Chart and Ontario Organizational Chart.

This example shows references to the Common Resource Management Procedure and site-specific organization charts for the Head Office (HO) and Ontario locations. While this model works well for a limited number of installations, it becomes impractical when the number of locations is significant.

Manual Reference Matrix

For companies with a large number of locations, where we need to reference numerous documents, including those controlled by satellite locations, we have another option. We can establish a document to connect the commitments of the corporate manual with the supporting documents specific to the site. Let’s call this document the Manual Reference Matrix and consider the following document reference structure: Corporate Manual Element > Manual Reference Matrix (ToC) Table of Contents > Site-Specific Manual Reference Matrix > Corresponding Site-Specific Document. To illustrate this model, let’s document the same element 5.5.1 from our corporate manual with references to site-specific organization charts:

The QW Enterprises, LLP management team ensures that 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 a common Resource Management Procedure and site-specific organization charts. To locate a site-specific organization chart, we must consult the manual’s reference matrix table of contents (ToC). This table of contents is simply a list of the manually referenced arrays for all locations, as shown in the following illustration:

Manual Reference Matrix Table of Contents Ministry of the Interior (Denver, Colorado, USA) Ontario (Canada) Saint Petersburg (Russia) Guanajuato (Mexico) Port Williams (Chile)…etc.

By following the “Ontario (Canada)” hyperlink we will find a site-specific manual reference matrix. Locating item 5.5.1 in the Ontario Manual Reference Matrix, we find that the Ontario location uses a document called the Ontario Organizational Chart for this clause of the manual. A manual reference matrix can 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 element 5.5.1, the Matrix indicates that the manual references the HO Organizational Chart for the corporate office and the Ontario Organizational Chart for the Ontario facility.

Now that we’ve successfully solved the problem of referencing site-specific documents, let’s see how we can address different scopes, exclusions, and the like. Let’s say our corporate office maintains an integrated management system that complies with ISO 9001:2008 and ISO 14001:2004. The corporate office management system meets all the requirements of ISO 9001 and therefore declares no exclusions.

At the same time, our Ontario facility is ISO 9001:2008 certified only and does not perform design functions, thus excluding design from its scope of certification. These differences can be documented within the Manual’s Reference Matrix itself. Section 1.1, Purpose and Scope of the Matrix, references ISO 9001:2008 and ISO 14001:2004 for the corporate office, while the Ontario facility only references ISO 9001:2008. Similarly, matrix element 1.2, Application, states for the corporate office: “Application, QW Enterprises LLP’s management system satisfies the full range of ISO 9001:2008 requirements”, while for the facility of Ontario, this item reads: “QW Enterprises LLP’s Ontario facility does not perform design functions, therefore design is excluded from the scope of this facility.” For a sample manual reference matrix, see the link below.

Control Manual Reference Matrix

It is a good idea to make the Manual Reference Matrix ToC part of your corporate manual. It is also beneficial to monitor your Manual Reference Matrix Template through your corporate documentation management system to ensure consistency of matrix format used by different locations. Each of your facilities will use this template matrix to document their site-specific references that address the corporate manual requirements.

After completing the Manual Reference Matrix in a given location, this document, like any other, will be given a document title and published through the local documentation change process. Any changes to the corporate manual should trigger a review and, if necessary, changes to the Manual Reference Matrix Template and Manual Reference Matrices for all locations.

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