PDF Guidelines for Developing Quality Documentation

INTERNATIONAL SEED TESTING ASSOCIATION (ISTA)

Secretariat, Z?richstrasse 50, 8303 Bassersdorf, CH-Switzerland Phone: +41-44-838 60 00, Fax: +41-44-838 60 01, Email: ista.office@ista.ch,

Guidelines for Developing Quality Documentation

Note: Any electronic or hard copies of this document are not subject to change service

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Guidelines for Developing Quality Documentation

A. INTRODUCTION

This document provides guidance for the development, preparation and control of quality manuals tailored to the specific needs of the user. The resultant quality manuals should reflect documented quality system procedures required by the ISTA Accreditation Standard. Examples are used to show one or several possibilities how requirements of the ISTA Accreditation Standard may be considered appropriately. All these examples originate from existing laboratory quality manuals; for confidentiality reasons references to the laboratories have been deleted. Another purpose of these examples is to show the great variety of possible solutions and to demonstrate that what may be appropriate for one laboratory does not necessarily represent the best solution for another one. This should encourage laboratories in finding suitable, customized solutions reflecting the laboratorys daily work. This document is considered to be a guideline and may not be complete as the continual improvement approach is assumed.

B. STRUCTURE AND FORMAT OF QUALITY MANUALS

The Q-documentation consists of at least the following three levels or parts also referred to as Document Hierarchy:

I. Quality Manual (Q-Manual) + annexes or appendices (comprising approximately 10-30 pages)

The purpose of a Q-Manual is to outline the general policies and procedures for staff, customers, accreditation bodies and/or legal bodies to provide an overview of the laboratorys quality system.

II. Documented quality system procedures such as Standard Operating Procedures (SOPs)

Standard Operating Procedures describe standard procedures in a concise manner to provide sufficient information to carry out the work concerned. The volume depends on the size of the laboratory, number of tests, number and qualification of staff and kind of equipment in use.

III. Other quality documents such as working instructions, forms, reports

Working instructions give details on the standard procedure concerned. This may be e.g. species related information on a specific test method. Forms, checklists, reports related to a standard procedure should be provided where appropriate. Working instructions or specimen forms may be directly attached to the respective SOP if applicable.

Q-Manual (Level A)

Describes the quality system in accordance with the stated quality policy and objectives and the accreditation standard

Describes the activities of individual functional units

Documented quality system procedures (standard operating procedures = SOPs)

(Level B)

Consists of detailed work documents

Other quality documents (work instructions, forms, reports, etc.)

(Level C)

There is no required structure or format for quality manuals, however, it should convey accurately, completely and concisely the quality policy, objectives and governing documented procedures of the laboratory. Each solution has its advantages and disadvantages.

Book/booklet:

Advantage: easy control of distributed copies

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Disadvantage: revisions of existing documents requires replacement of the whole document and all its copies Ring binder: Advantage: revisions of existing documents by replacing single pages/chapters or entire SOPs, less time and cost consuming Disadvantage: it may be more difficult to control distributed copies. A thorough document change service needs to be established It is recommended to use a flexible system like ring binders since changes often occur, ideally supplemented by an intranet component. It has to be noted that the following principles have to be applied accordingly to computerised systems. Cover-sheet of the Q-Document chapters This page should give minimum information such as laboratorys name and contact details, name of document, indication of approval ("approved by: "), copy number, i.e. a unique number for each controlled copy and - if applicable, an indication "controlled document" ? "uncontrolled document". The rationale behind this is to facilitate identification and control of all the single elements forming the Qdocumentation (Example 1).

C. HOW TO START WITH THE PREPARATION OF A Q-MANUAL? The process of establishing a quality assurance system documentation should begin with appointment of the coordination task to a management-delegated competent body, which may be an individual or a group of individuals. The appointee or the group of appointees is responsible for the following tasks: to obtain data on the actual state of the quality assurance system to plan the documentation system to collect and compile existing documentation and require additional documentation where

necessary to review the documentation to ensure clarity, suitability and proper structure to develop a distribution policy to incorporate pertinent changes to act as contact person/s in all matters of the quality assurance system D. THE Q-MANUAL Q-manuals may be developed and used by an organisation for purposes including, but not limited to the following: communicating the laboratorys quality policy, procedures and requirements describing the quality system providing documented bases for auditing quality systems providing continuity of the quality system and its requirements during changing circumstances training personnel in the quality system requirements and methods of compliance presenting the quality system for external purposes, such as demonstrating compliance with

respective accreditation standard

E. WHAT TO INCLUDE IN A QUALITY MANUAL? 1. Scope and field of application

In the scope or field of application it shall be clearly stated for which activities/departments of the laboratory the Quality Manual is valid. 2. Table of contents (indicating title of chapters/sections and subchapters/subsections)

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The numbering or coding system of sections, subsections, pages, figures, exhibits, diagrams, tables, working sheets, etc., should be clear and logical

3. Definitions and explanation of laboratory specific abbreviations

4. Policy and Quality Objectives

4.1. In this section, intentions and objective targets of the laboratory incl. a statement that the seed testing laboratorys standard of service will be in accordance with the requirements of the ISTA Accreditation Standard and the current version of the ISTA Rules (Example 2) (Example 3) are stated. It should also describe how the quality policy is made known to, and understood by, all employees and how it is implemented and maintained at all levels. NOTE: A description of the activities of the laboratory is not a substitute for the Q-policy statement.

4.2. Based on the Quality Policy, Quality Objectives shall be determined. Objectives shall be quantifiable (current value, target value, time period) to facilitate a target/actual value comparison (Example 4). The Q-objectives need not necessarily to be included in the Qmanual; a mere reference to the document where they are to be found, for instance an annual plan, would be sufficient. Determination and verification of achievement of the objectives is to be made at least annually in the management review, see below or in other relevant planning documents.

5. Description of the Q-System and the Document Control Procedure

5.1. Explanation of the structure of the Q-documentation, e.g. how many levels, what kind of documents are used (Q-Manual, SOPs, if applicable work instructions (WI), forms, log books, checklists, loose sheet copies, etc.). The description should ensure that somebody using the document understands the way it is to be used (Example 5).

5.2. There should be a description of the document identification system (e.g. "SOP 01" or "SOP A01", e.g. "A" stands for Administration, or "F1" for the form number 1).

5.3. Purpose of document control procedures is to guarantee that each page of the Qdocumentation is identifiable and attributable. Document issue and change control are essential to ensure that the content of the quality documentation is properly authorized. The document control system defines who and in which way suggestions for changes in the documents can be made, who decides on necessary amendments and the time frame when changes are due. It is recommended to create a form where suggestions/revisions are noted and brought to the attention of the person responsible for the revision (Example 6)

5.4. Each page of the Q-documentation should at least contain (Example 7):

Name of the document

Page number: It is recommended to number the pages of each QM-chapter or SOP separately rather than numbering the pages consecutively for the whole document. The format must be as "page X of Y" instead of only "page X"

Revision status

Version number (or "valid since date")

Control indication such as ,,This is a controlled document" or ,,This document is not subject to change service".

5.5. A description should also be given about how external documents are controlled (e.g. ISTA Rules, ISTA Laboratory Accreditation Standard).

5.6. The distribution concept outlines the addressees/recipients for controlled or uncontrolled copies of the document. If documents are distributed electronically or by mail, explanation must be given on how the laboratory ensures that the new versions were received. This may be done by listing the documents on a master list of controlled documents (or document matrix) (Example 8).

A master list of controlled documents should at least contain the following:

name of the document (and document code)

version number of current document

approval date

recipients (can be person(s) and/or a place, e.g. room number)

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 person responsible for distribution of new or revised documents

6. Organisation and Management

6.1. Description of the organization, responsibilities and authorities: In this section the laboratory should provide a description of the high-level structure of the organisation. This may be preferably made by an organisational chart, where responsibilities, authorities and interrelationship structure are included (Example 9). It puts the laboratory and sampling unit in the overall context within a larger organisation, e.g. the institute within the ministry of agriculture, or the seed testing laboratory unit within a seed company, and the organisational structure within the laboratory (Example 10) to define and show sections/departments (staff administration, financial department, how sampling is linked to the laboratory), functions or positions, (technical manager, quality manager), sample reception/registration, testing sections, issuance of ISTA Certificates.

6.2. Independence of judgement and integrity in relation to sampling and seed testing activities: The laboratory must describe how it meets these requirements of the ISTA Accreditation Standard (more especially paragraph 3.5 of the ISTA Accreditation Standard, Version 5.0, 2007).

6.3. Defining the responsibility of the management, i.e. providing resources (human and financial resources), determining the Q-policy and Q-aims, management review, promoting quality assurance system to increase awareness, motivation and involvement.

7. Staff and Training

7.1. Description of responsibilities and authorisations of laboratory functions and positions (e.g. head of the laboratory, technical manager, quality manager, supervisors, technicians/analysts, administrative personnel, trainees, etc.)

7.2. Laboratory staff matrix showing responsibilities and deputies in key activities (Example 11).

7.3. Description of the general policy concerning internal and external training (i.e. workshops, instruction, on-the job training, etc.). How does the laboratory management determine the individual training needs? What are the criteria (e.g. based on annual performance appraisals)? What is the basis to set up an annual training plan or how are training needs identified and recorded? How is training recorded?

7.4. Description of a general training procedure for new staff members. This general description is supplemented by a more detailed SOP describing the training programme for new staff members. (Example 12)

8. Laboratory Premises

8.1. In this section the laboratory premises should be described, if possible including a floor plan. If applicable, provisions taken against excessive temperatures and moisture, vibration (stable work benches and tables) should be mentioned as well as measures taken to protect the staff in terms of health and safety (e.g. testing of coated seed). A brief description how good housekeeping in the testing laboratory is ensured should be included.

8.2. Definition of appropriate regulations for access and use of the laboratory premises by the staff during working hours and off-time and definition how entry of persons external to the laboratory (staff of foreign sections, clients or other visitors) is controlled and how it is ensured that external persons are not left unattended in the laboratory premises.

8.3. Sample storage: This section contains a description of the sample storage system (i.e. where, how, how long the samples are stored and which components of the samples, i.e. only remainder of submitted samples or with the other seeds and inert matter found, are stored), control/treatment and recording of pests and diseases, control and recording of relative humidity and temperature. Definition of procedures for disposal of stored samples (e.g. treated versus untreated seeds).

9. Purchasing of Services and Supplies

9.1. General description of the procedure for the selection and purchasing of laboratory services and supplies including description of records in place.

9.2. Services and supplies that affect the quality of tests must be identified. Those critical services (e.g. external calibration of weights needed for the balances) and critical supplies (e.g. germination substrate, chemicals) must be checked to verify compliance prior to use.

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