The quality management system is supported by the document system, which is why it is vitally important in achieving quality, which is nothing more than the satisfaction of customer needs.
There are several methodologies for the implementation of quality management systems, and all of them coincide in considering the preparation of documentation as one of their stages, but the issue of how to achieve the effective functioning of the document system and what processes is not discussed in depth. it implies. That is why this work was carried out, with the aim of developing a methodology to implement a document system that meets the requirements of the ISO 9000: 2000 standards and serves as a reference to any organization that is involved in this complex task.
Applying the process approach, it was possible to characterize the documentation processes and propose the necessary steps to implement the document system that serves as the basis for the quality management system in any type of organization.
INTRODUCTION
Quality has become in today's globalized world, an unavoidable necessity to remain in the market. For this reason, quality management systems based on ISO 9000 standards, which reflect the international consensus on this subject, have become very popular, and many organizations have decided to take the path of implementing it.
Cuba is not alien to this process. The disappearance of traditional markets has forced the country to try to introduce its products and services in the international market, which has made the implementation of quality management systems an imperative for many companies. In fact, in 2002, 90 Cuban companies already have certified quality management systems, with a trend towards an increase in the number as the Business Improvement process advances.
Documentation is the support of the quality management system, since it contains not only the ways of operating the organization but all the information that allows the development of all processes and decision-making.
There are various methodologies for the implementation of quality management systems, and all their authors agree in considering the preparation of documentation as an important stage, but there is a tendency to reduce the focus of this issue to offer some advice for the elaboration of documents (mainly the Quality Manual and procedures), when it is not only a question of preparing them but of guaranteeing that the document system works as such and becomes an effective tool for the administration of the processes.
Therefore, this work aims to offer a methodology to implement a document system that meets the requirements of the ISO 9000: 2000 standards, and can be applied by quality specialists of any organization that faces the complex task of establishing a quality management system.
DEVELOPING
The proposed methodology has six stages and is described in a general way in the following scheme:
STAGE 1. Determination of documentation needs.
Objective: Determine the types of documents that must exist in the organization to guarantee that the processes are carried out under controlled conditions.
Chores:
- Study in the ISO 9000 standards the elements of the documentation applicable to the organization.
The 2000 version of the ISO 9000 standards give the possibility of applying common sense and deciding according to the characteristics of the organization in terms of size, type of activity carried out, complexity of processes and their interactions, and competition of personnel, the extension of the quality management system documentation. However, they require the existence of the following documents:
- Documented statements of a quality policy and quality objectives Quality Manual Documented procedures for: Document control Control of quality records Internal audits Control of non-conforming products Corrective actions Preventive actions Required documents by the organization to ensure the effective control, operation and planning of its processes Records for: Reviews made by management to the quality management system Education, training, skills and experience of the personnel Processes of product realization and compliance with requirements Product requirements Review of requirements related to the product Design and development input elements Design and development verification results Design and development validation resultsControl of changes in design and development Evaluation of suppliers Control of measurement and monitoring equipment when there are no national or international standards Results of verification and calibration of measurement instruments Internal audits Authority responsible for commissioning of the product Treatment of non-conformities Corrective actions Preventive actions
- Study the specific regulations of the sector in which the organization operates to determine the documents that must respond to compliance with these legal requirements.
Each sector establishes certain regulations that must be complied with to guarantee the uniformity of the products and services offered by its organizations and compliance with the legal requirements imposed by the state as a representative of the interests of society as a whole. We can cite, for example, in the pharmaceutical sector Good Pharmaceutical Production Practices, in the Health sector, Good Clinical Laboratory Practices, in the software sector, the ISO SPICE standards and the CMM evaluation model, among others. That is why the quality system documentation must harmonize the generic ISO requirements with the specific requirements of the sector in which the organization operates.
- Determine the types of documents that should exist and their requirements.
With the results of the previous tasks, it must be decided which are the types of documents that must exist in the organization to comply with the requirements of the ISO 9000 standards and the regulations of the sector. So we usually have to have organizations:
- Quality Manual Procedures Manuals General and specific procedures Records Quality Plans Specifications
In addition, there may be other documents such as:
- Inspection and test plans Product master files Reports Plans Drawings, diagrams Labels Certificates Prospects Regulations Invoices Storage cards Models Instructions
These documents can be useful to obtain the results that the organization wants in terms of quality management.
Stage 2. Diagnosis of the documentation situation in the organization.
Objective: To know the situation of the documentation in the organization, comparing what exists with the needs determined in the previous stage.
Chores:
- Prepare the guide for diagnosis
When preparing the guide, the documentation needs determined in the previous stage should be taken into account, as well as the requirements that the documentation must meet.
In this case, a questionnaire organized by the requirement of the ISO 9001: 2000 standard was prepared, also taking into account the quality documentation requirements found in the consulted bibliography.
- Run the diagnostic.
To carry out the diagnosis, the guide should be used and techniques such as observation, interview and document review should be applied. The existence or not of the documents must be determined, to what extent they meet the established requirements for documentation and whether they are being used properly.
- Prepare and present the diagnostic report.
The report must contain the existing documents by process, their adaptation or not to the requirements and their correct use or not, according to the results of the diagnosis. It must be presented to senior management.
Stage 3. Design of the documentary system.
Objective: To establish all the general elements necessary for the elaboration of the Documentary System.
Chores:
- Define the hierarchy of documentation.
To perform this task, the documentation must be classified and its hierarchy defined using a single criterion. Usually the pyramid criterion that appears in ISO 10013: 94 is used, where the Quality Manual is located at the highest level, procedures at the second level, and instructions, records, specifications and other documents at the third level. Another criterion is the one that classifies regulatory documents into three levels: the first where the Quality Manual is found, the second where the general procedures are found, and the third where the specific procedures, specifications, and other documents are found. The records are not regulatory documents and do not fall within this classification.Both criteria do not place the regulatory documentation of external origin anywhere within the hierarchy (example: ISO 9000 Standards, Cuban Standards applicable to the specific entity) but these documents must also be controlled.
- Define authority and responsibility for the preparation of documentation at each level.
The preparation of the documentation is a good opportunity to involve all the personnel in the quality management system, so it must be deployed throughout the organization according to the hierarchical levels established in the previous step and the existing organizational structure.. Thus, the Quality Manual, which is the document with the highest hierarchical level, must be prepared by a group of people from different areas led by a representative of the management with defined authority to make decisions regarding the quality management system. General procedures must be prepared by middle management personnel and specific procedures, specifications, records, etc., by personnel who will use them later.
- Define the structure and format of the Quality Manual.
The group of persons designated to prepare the Quality Manual must define, based on the ISO 9001 and 9004 standards, the structure and format of the Quality Manual, taking into account the permissible exclusions. This structure will have the following parts:
- Title Summary about the manual Table of contents Brief description of the organization Scope (including any permissible exclusions) Terms and definitions Quality Management System
- Management responsibility Resource management Product materialization Measurement, analysis and improvement.
The format of the manual must take into account compliance with the requirements established for documentation and facilitate its consultation and updating.
- Determine the documentation processes.
To determine the documentation processes, we propose to use the following approach that breaks them down into two general processes:
- Management of technical documentation Use of documentation
These general processes were disaggregated into their specific processes
- Management of technical documentation: Use of documentation
These specific processes are in turn disaggregated into unit processes and the inputs and outputs of each of them are determined:
- Processing planning
Inputs: information on the need for documentation and the real possibility of satisfying this need.
Outputs: Document preparation plan
Unit processes:
- Elaboration
Inputs: Document preparation plan
Outputs: Document project
- Review
Entries: Draft document
|
Outputs: Draft document corrected and ready to approve.
- Approval
Entries: Draft revised document
Outputs: Approved document
- ID:
Tickets: Approved document
Outputs: Document identified with a code
- Reproduction
Entries: Document approved and identified
Outputs: Document reproduced in the number of copies required
- Distribution
Tickets: document to distribute
Departures: document distributed in the areas
- Archive
Entries: document to be filed
Outputs: archived document
- Verification
Tickets: Current document
Outputs: Checked document
- Modification
Tickets: current document
- Repeal and / or destruction
Entries: checked document declared obsolete
Departures: document repealed and / or destroyed
- Query
Tickets: Request for consultation
Outputs: consulted document
- Release (in the case of records)
Entries: full records
Outputs: records reviewed
- Establish the flow of documentation.
In this task, the flow of documentation must be organized in such a way as to ensure that the documents are in the required place in a timely manner and that the information is accessible to authorized persons.
- Prepare the document preparation plan
To complete this task, the unit processes described for this process in the fourth task must be followed.
- Plan the training of the personnel involved.
To do this, the training needs and the resources available to carry it out must be taken into account.
Stage 4. Preparation of documents.
Objective: prepare, review and approve all documents at each level.
Chores:
- Train the personnel involved.
In this task, the training planned in the previous stage will be carried out.
- Prepare general procedures.
To develop the general procedures it is suggested to use the following structure:
| Parties | Character | Content |
| objective | required | Define the objective of the procedure |
| Scope | required | Specify the scope of application of the procedure |
| Responsibilities | required | Designate those responsible for executing and supervising compliance with the procedure |
| Terms and definitions | Optional | Clarify if necessary the use of non-common terms or definitions applicable to the procedure. |
| Process | required | It will describe in chronological order the set of operations necessary to execute the procedure. |
| Documentation requirements | required | It will list all the records that must be completed during the execution of the procedure. |
| References | required | It will refer all those documents that have been consulted or mentioned in the procedure |
| Annexes | Optional | It will include the format of the records, plans, tables or any other material that facilitates the understanding of the procedure. |
- Prepare the Quality Manual.
The selected group will prepare the Manual in accordance with the format established in the design stage, taking into account the necessary participation of all the areas involved.
- Prepare other documents in accordance with the plan drawn up in the previous stage.
The other documents will be prepared according to the plan and following the instructions prepared for each type of document that must have been learned during the training.
- Review and approve all documents by authorized competent personnel.
The revision and approval of the documentation will be carried out as it is developed.
Stage 5. Implementation of the documentary system.
Objective: Put into practice what is established in the documents prepared.
Chores:
- Define the implementation schedule.
To carry out this task, the characteristics of the organization and existing resources must be taken into account.
- Distribute the documentation to all those involved.
The approved documentation must be distributed to the areas as it is approved.
- Determine training needs and update training plan.
When there are difficulties with the implementation of a procedure and training needs are determined, the plan prepared must be updated and the corrective action carried out in the shortest period of time possible.
- Put into practice what is established in the documents Collect documented evidence of the above.
Stage 6. Maintenance and improvement of the system.
Objective: Maintain the adequacy of the system to the needs of the organization through continuous improvement.
Chores:
- Carry out internal audits to identify opportunities for improvement. Implement corrective and preventive actions aimed at eliminating nonconformities in the documentation.
CONCLUSIONS:
The work carried out provides organizations with a methodology to implement their document system in accordance with the ISO 9000: 2000 standards and guarantee the support of their quality management system.
BIBLIOGRAPHY.
- National Quality Information Center. Implementation of a quality system according to the UNE-EN-ISO-9002 standard. Internet, January 2000 Crosby, Philip. Quality is free. The art of making quality certain. New American Library, USA 1980. Workshop course on documentation of quality management systems. MACNOR SA. ICTEC training course. La Habana, 1988.Course “Development of a quality management system according to ISO 9000. SGS Supervise (Switzerland) SA Suscursal en Cuba.De Sain, Carol. Documentation basics. Master Production Batch Records ”. BioPharm, Nov-Dec 1991. De Sain, Carol. "Designing GMP and facility qualitation Master protocols". BioPharm, April 1992. From Sain Carol. "Standard Operating Procedures and Data Collection Forms". BioPharm, October, 1991.Freyre, Luis O. “The quality and standards of the ISO 9000 family.The only way to reach the market ”. Normalization Magazine No.2, 1997 pp. 3-14. Garcia, Sonia. "Design of the documentation system of the Finlay Institute". Thesis to opt for the title of specialist in quality assurance. February 1999. Gómez Beltrán, JR “Quality planning. Material for the Master in Quality Assurance ”. ISPJAE, 1998. González, Aleida. "Total quality costs". Material for the master's degree in Quality Assurance. ISPJAE, 1998. Gongora, Yoannia and Santana, Yunelis. “Methodology for the implementation of an ISO 9000 documentary system. Thesis to opt for the title of Industrial Engineer. 2001. Juran, JM; Gryna, Frank M. "Quality Planning and Analysis." Editorial Reverté, Spain, 1981.ISO 9000: 2000. Vocabulary ISO 9001:2000 Standards for Quality Management and Quality Assurance ISO 9004: 2000 Quality Management and elements of Quality Systems. Part 1. Guidelines. Pinto Molina, María. Journal of librarianship and documentation. Publications service. University of Murcia. Vol. 1, 1998.Portuondo, Ma. Elena et al. "Methodology for the design and implementation of a quality technical documentary system with ISO 9000 standards". National Center for Biopreparations. Havana, 1996.Senlle, Andrés and Vilar, Joan. "ISO 9000 in service companies". Ediciones Gestión 2000 Spain, 1997.Sosa Vera, Rita. Development of a quality system in a food quality control laboratory. Normalization Magazine No.3 / 1997.Maria. Journal of librarianship and documentation. Publications service. University of Murcia. Vol. 1, 1998.Portuondo, Ma. Elena et al. "Methodology for the design and implementation of a quality technical documentary system with ISO 9000 standards". National Center for Biopreparations. Havana, 1996.Senlle, Andrés and Vilar, Joan. "ISO 9000 in service companies". Ediciones Gestión 2000 Spain, 1997.Sosa Vera, Rita. Development of a quality system in a food quality control laboratory. Normalization Magazine No.3 / 1997.Maria. Journal of librarianship and documentation. Publications service. University of Murcia. Vol. 1, 1998.Portuondo, Ma. Elena et al. "Methodology for the design and implementation of a quality technical documentary system with ISO 9000 standards". National Center for Biopreparations. Havana, 1996.Senlle, Andrés and Vilar, Joan. "ISO 9000 in service companies". Ediciones Gestión 2000 Spain, 1997.Sosa Vera, Rita. Development of a quality system in a food quality control laboratory. Normalization Magazine No.3 / 1997.1996.Senlle, Andrés and Vilar, Joan. "ISO 9000 in service companies". Ediciones Gestión 2000 Spain, 1997.Sosa Vera, Rita. Development of a quality system in a food quality control laboratory. Normalization Magazine No.3 / 1997.1996.Senlle, Andrés and Vilar, Joan. "ISO 9000 in service companies". Ediciones Gestión 2000 Spain, 1997.Sosa Vera, Rita. Development of a quality system in a food quality control laboratory. Normalization Magazine No.3 / 1997.
AUTHOR INFORMATION
Zulem Pérez Rodríguez.
Degree in Chemistry. Master in Quality Management.
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