Il forum sulla Qualità di QualitiAmo

[QualitiAmo - Stefania]

Su Monetary Review potete leggere un articolo dla titolo: "Quality Control - Common ISO 9001 Manuals for large corporations.".

Questa è la versione tradotta in italiano con il traduttore automatico di Google.

While numerous successful models of ISO 9001 quality management systems have been developed and are being used in various industries, approaches to documenting top level management systems for multi-location enterprises are limited at best. This article discusses a method for establishing an ISO 9001 top-level documentation structure that allows a business with multiple facilities to use common quality management system manual. This model significantly improves consistency of the corporate message regarding quality policies, while reducing the number of documents within the organization’s quality management system.

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 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.

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.

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.

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.

If a business wishes to establish a quality manual that will serve all its facilities, we need to consider a different route. Let’s start from an example of a clause 5.4.1, Planning, Quality objectives. This clause may state: ABC Corporation’s Management Team ensures that quality objectives, including those needed to meet requirements for product, are established for relevant functions and levels within the organization per the Management Review Procedure and the Quality Objectives Matrix.

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.

But, what if your sites use their own service procedures, incoming procedures, in-process test criteria and other unique documents different form corporate procedures? Let’s examine how an organization’s ISO 9001 quality manual can reference corporate and site-specific procedures.

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.

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 element

Manual Reference Matrix Table of Contents (ToC)

Location Manual Reference Matrix

Corresponding site-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

Home Office (Denver, Colorado, USA)

Toronto (Canada)

Jacksonville, IL (USA)

Guanajuato (Mexico)

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.

Let’s say we need to locate a Data Analysis Procedure for our Los Angeles plant. When we find this location in our Manual Reference Matrix table of contents, we actually will connect to the location’s Manual Reference Matrix. Finding the corresponding clause number in the site’s Manual Reference Matrix, we will find a site-specific procedure title that addresses our clause of the quality manual.

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.
_________________
Stefania - Staff di QualitiAmo

ISO 9001:2015 - SI AGGIUNGE ALLA COLLANA DEI LIBRI DI QUALITIAMO IL NUOVO TESTO CHE SVELA I SEGRETI DELLA FUTURA NORMA



IL PRIMO LIBRO NATO SULLE PAGINE DI QUALITIAMO



HAI DATO UN'OCCHIATA AL REGOLAMENTO DEL FORUM PRIMA DI SCRIVERE IL TUO MESSAGGIO?