OBJECTIVES OF QUALITY ASSURANCE SYSTEMS BASED IN THE RULES: GLP Good Laboratory Practices ISO17020 Inspection ISO17025 Assay

& Calibration ISO9001

Joan Rabasseda Head of Projects Laboratori Agroalimentari - DARP Ljubljana, April 18th 2006
Generalitat de Catalunya Departament dAgricultura, Ramaderia i Pesca

QUALITY CONTROL vs QUALITY ASSURANCE

Generalitat de Catalunya Departament dAgricultura, Ramaderia i Pesca

Why de we need a Quality Management System?

To demonstrate the validity of the results To ensure that the quality of the results is under control To keep procedures for identification, collection, indexing, access, storage, maintenance and disposal of all significant / important records The records for each analysis shall contain sufficient information Traceability ...
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FREE TRADE

How do we get our work?

SAME PROCEDURES? CORRECTNESS? RELIABILITY? COMPARABILITY? ALL ALL RECORDED?

QUALITY SYSTEM REQUIREMENTS?

Generalitat de Catalunya Departament dAgricultura, Ramaderia i Pesca

Generalitat de Catalunya Departament dAgricultura, Ramaderia i Pesca

SAME TERMS? VOCABULARY?

SAME EQUIPMENT?

Generalitat de Catalunya Departament dAgricultura, Ramaderia i Pesca

RELAIBLE RESULTS

DEMONSTRATE TECHNICAL COMPETENCE

EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM

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Main Quality Rules

1962 FDA Good Manufacturing Practices 1976 FDA Good Laboratory Practice Regulations for Nonclinical

Laboratory Studies (Mandatory legal framework since 22/07/1979).

1981 OEDC principles of GLP 1989 EN45001

1992 EFQM
1997 1998 1999 2000 OECD Principles of Good Laboratory Practice ISO17020 and EN45011 ISO17025 ISO9001

2002 CAF Model

2005 ISO17025
Generalitat de Catalunya Departament dAgricultura, Ramaderia i Pesca

Quality framework

ISO9000
Pattern for quality assurance For any kind of company or sector For products and services Voluntary scope

ISO17025
To get quality analytical results For laboratories

GLP
Assessment of potential risk on health & environment For laboratories

Mutual acceptance of results Voluntary and compulsory scope

Non clinical assays with legal purpose (registry) Compulsory scope

Generalitat de Catalunya Departament dAgricultura, Ramaderia i Pesca

Quality framework
ISO9001:2000 ISO17025:12005
6.1 b) 4.4.1, 4.7, 5.4.2, 5.4.3, 5.4.4, 5.10.1

Cross-references
Review of requests, tenders contracts Service to the client Test and calibration methods method validation Reporting the results Personnel Equipment Organization Preventive actions Accommodation and conditions and

and

6.2.1, 6.2.2 a), 6.2.2 b), 6.2.2 c), e) 6.2.2 d), 6.3.1 a)

5.2.1, 5.2.2, 5.5.3, 5.2.1, 5.2.2, 5.2.2, 5.2.5 4.1.5 k) 4.1.3, 4.12.1.2, 4.12.1.3, 5.3 4.12.1.4, 5.4.7.2, 5.5, 5.6

environmental

6.3.1 b)

Control of data Equipment Measurement of traceability

Generalitat de Catalunya Departament dAgricultura, Ramaderia i Pesca

Quality framework
ISO9001:2000 ISO17025:12005
6.3.1 c) 4.6, 5.5.6, 5.6.3.4, 5.8, 5.10

Cross-references
Purchasing services and supplies Equipment Transport and storage (MRC) Handling of test items Reporting the results Accommodation conditions and environmental

6.4) 7.1, 7.1 a), 7.1 b)

5.3.1, 5.3.2, 5.3.3, 5.3.4, 5.3.5 5.1, 4.2.2, 4.1.5 a), 4.2.1, 4.2.3

General Quality system policies and objectives Quality manual Laboratory duties Test methods and method validation Assuring the quality of tests results

7.1 c), 7.1 d)

5.4, 5.9, 4.1, 5.4, 5.9

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Quality framework
ISO9001:2000 ISO17025:12005
7.2.1 7.2.2 7.2.3 4.4.1, 4.4.5, 4.4.1, 4.4.5, 4.4.2, 4.4.2., 4.4.3, 4.4.4, 5.4, 5.9, 5.10 4.4.2, 4.4.3, 4.4.4, 5.4, 5.9, 5.10 4.4.4, 4.5 , 4.7, 4.8

Cross-references
Review of requests, tenders and contracts Test methods and method validation Assuring the quality of tests results Reporting the results Technical requirements Test methods and method validation Assuring the quality of tests results Purchasing services and supplies Technical requirements Test methods and method validation Equipment Measurement traceability Assuring the quality of tests results

7.3

5. 5.4, 5.9

7.4.1, 7.4.2, 7.4.3 7.5.1, 7.5.2, 7.5.3, 7.5.4

4.6.1, 4.6.2, 4.6.4, 4.6.3, 4.6.2 5.1, 5.2, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9 5.2.5, 5.4.2, 5.4.5 5.8.2 4.1.5 c), 5.8

Generalitat de Catalunya Departament dAgricultura, Ramaderia i Pesca

Quality framework
ISO9001:2000 ISO17025:12005
7.5.5 7.6 4.6.1, 4.12, 5.8, 5.10 5.4, 5.5

Cross-references
Selection of purchasing services Preventive actions Handling of test items Reporting the results Test methods and method validation Equipment Improvement Test methods and method validation Assuring the quality of tests results Corrective actions Internal audits Subcontracting Purchasing services and supplies Control of non conforming work Preventive actions

8.1 8.2.1 8.2.2 8.2.3 8.2.4, 8.3, 8.4, 8.5.1, 8.5.2, 8.5.3

4.10, 5.4, 5.9 4.10 4.11.5, 4.14 4.11.5, 4.14, 5.9 4.5, 4.6, 4.9, 5.5.2, 5.5.9, 5.8, 5.8.3, 5.8.4, 5.9, 4.9, 4.10, 5.9, 4.10, 4.12, 4.11, 4.12, 4.9, 4.11, 4.12

Generalitat de Catalunya Departament dAgricultura, Ramaderia i Pesca

Quality framework
ISO17020
Independence, impartiality and integrity Confidenciality Organization/ management:
responsibilities documented, job description, supervision, training

EN45011
General provisions
non-discriminatory criteria

GLPs
Responsibilities:
test facility management study director principal investigator study personnels

Organization:
management impartiality documented structure formal rules and structures resolution of complaints

Quality System:
Policy and objectives Quality manual (content) Control of documents Internal quality audits Corrective actions Review of quality system

Quality Assurance Programme Facilities:

test system handling test and reference items archive waste disposal

Operations Quality System

authority and responsibility management review administrative procedures personnel

Personnel Facilities and equipment

Apparatus, Material, and Reagents Test system Test and reference items

Generalitat de Catalunya Departament dAgricultura, Ramaderia i Pesca

Quality framework
ISO17020
Inspections methods and procedures Handling of inspections samples an items Records Inspection reports and inspection certificates Subcontracting Complaints and appeals Cooperation

EN45011
training personnel subcontractors handling nonconformities evaluation procedures complaints and disputes internal audits

GLPs
Standard Operation Procedures Performance study
study plan content study plan conduct study plan

Conditions and procedures Internal audits and management reviews Documentation Records Confidenciality Personnel qualification Changes in certification requirements

Reporting of study results Storage and retention of records and materials

Generalitat de Catalunya Departament dAgricultura, Ramaderia i Pesca

Quality framework
ISO17020 EN45011
Appeals complaints and disputes Information on the procedures for certification Preparation for evaluation Evaluation Decision on certification Surveillance Use of licences (conformity)

GLPs

Generalitat de Catalunya Departament dAgricultura, Ramaderia i Pesca

Quality framework
ISO9001, ISO17025, ISO17020, EN45011, GLP:
Management commitment Quality policies and objectives Quality system documented:
Quality manual Procedures

Deming circle in all activities:

Plan Do Check Act
Generalitat de Catalunya Departament dAgricultura, Ramaderia i Pesca

Common quality framework

1. Request, tender and contract review 10. Handling of test items
WORK

2. Sub-contracting
3. Purchasing services and supplies 4. Service to the client 5. Complaints 6. Control of data and records 7. Document control 8. Traceability 9. Personnel policies
Generalitat de Catalunya Departament dAgricultura, Ramaderia i Pesca

11. Control of nonconforming testing work 12. Corrective action 13. Preventive action 14. Internal audits 15. Management reviews 16. Reporting the results

ISO9000 - ISO17025
Certification against ISO 9001 does not of itself demonstrate the competence of the laboratory to produce technically valid data and results. Testing and calibration laboratories that comply with ISO17025 will therefore also operate in accordance with ISO 9001.
ISO/IEC 17025:2005

Generalitat de Catalunya Departament dAgricultura, Ramaderia i Pesca

ISO17020 - General Criteria for the Operation of Various Types of Bodies Performing Inspection
Accreditation for Inspection
Administrative requirements (Clause 3) Organization and Management - Supervision Quality System (Clause 7.1-7.9) Internal Audit (Clause 7.7 and 7.8) Personnel (Clause 8) Training (Clause 8.2) Equipment (Clauses 9.7 and 9.8) Reporting (Clause 13) Sub-Contracting (Clause 14)
(Clause 6)

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ISO17020 - General Criteria for the Operation of Various Types of Bodies Performing Inspection
Administrative requirements:
In addition to any liability insurance required by law or due to contractual obligations, all types of inspection body shall have public liability insurance cover. Inspection bodies which supply services to organizations other than their own, shall also be covered by professional indemnity.

Generalitat de Catalunya Departament dAgricultura, Ramaderia i Pesca

ISO17020 - General Criteria for the Operation of Various Types of Bodies Performing Inspection
Organisation and Management - Supervision
The Inspection Body shall be able to demonstrate that it is organised in such a way that the work of the staff performing inspections is supervised by personnel who are familiar with the objectives of the inspections, the inspection methods and procedures being used and the assessment of inspection results. The extent, nature and level of supervision exercised shall take into account the qualifications and experience of the inspection staff and the inspections being undertaken. The supervision of inspection personnel shall also include the regular review of inspection reports by technical personnel to ensure that work has been carried out in accordance with relevant legislation, the Inspection Body's procedures and contractual obligations as agreed with the client.
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ISO17020 - General Criteria for the Operation of Various Types of Bodies Performing Inspection
Quality System
Where a company provides inspection from a number of locations, under central technical and quality control, the following criteria apply:
The central quality system shall embrace each individual location from which accredited inspection services are to be operated. There shall be a technical manager in the parent company, supported by local deputies where necessary, who has overall technical control and can ensure that all aspects of EN 45004 are implemented at all times at each location. This control shall be clearly defined in the quality manuals and the organizational charts.
Generalitat de Catalunya Departament dAgricultura, Ramaderia i Pesca

ISO17020 - General Criteria for the Operation of Various Types of Bodies Performing Inspection
Quality System
Where a company provides inspection from a number of locations, under central technical and quality control, the following criteria apply:

There shall be a quality manager for the parent company, with local deputies where necessary, responsible for day-to-day implementation of the quality system. This quality manager shall have direct access to top management and the responsibilities of both the quality manager and deputies shall be clearly defined in the quality manual. Each location shall operate to the same technical policy and technical procedures for a given field and type of inspection. Policy on calibration of equipment shall be controlled centrally even though it may be performed locally. Each location shall be audited annually
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ISO17020 - General Criteria for the Operation of Various Types of Bodies Performing Inspection
Internal Audit
The internal audit programme shall include the on-site assessment of inspection personnel carrying out inspections. On-site assessment shall be carried out by personnel with the relevant technical qualifications and experience who have been trained in internal auditing and who are sufficiently independent to carry out the assessment audit objectively. The programme shall also ensure that each of the inspectors engaged in inspection is assessed at least once within a period of 4 years for each of the fields in which they are active. The audit programme shall ensure that where inspections are managed from locations other than a central location, the audit programme encompasses these different locations in a systematic way over the 4 year period.
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ISO17020 - General Criteria for the Operation of Various Types of Bodies Performing Inspection
Personnel
Qualifications and Competence
The Inspection Body shall ensure that only staff who have, as a minimum, the qualifications, training, experience (including knowledge of the inspections to be carried out) Supervise inspectors, resolve technical issues and perform inspections, calibrations and testing. The Inspection Body shall maintain records of qualifications, training and experience of all staff associated with the inspection process, together with records of how and when each member of staff was authorized. These records shall indicate the fields and levels of inspection, calibration and testing considered to be within the competence of the inspector. Including part-time employees or temporary staff
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TRAINING

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ISO17020 - General Criteria for the Operation of Various Types of Bodies Performing Inspection
Equipment
All equipment used for measurements and tests where the results of such measurements and tests have a significant influence on the results of the inspection, ie the conclusion about conformance with requirements, shall be readily identifiable, suitable for the intended purpose and calibrated in accordance with a defined programme so as to ensure that, wherever applicable, measurements made by the Inspection Body are traceable to national standards of measurement. Where the calibrations are performed in-house, traceability to national standards of measurement shall be assured The certificate or equivalent must detail an uncertainty of measurement that is appropriate for the equipment that is to be calibrated from the reference standard.
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External suppliers

ISO17020 - General Criteria for the Operation of Various Types of Bodies Performing Inspection

Reporting requirements Sub-Contracting requirements

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ISO17025 - General requirements for the competence of testing and calibration laboratories
Organization and management Quality system Document control Request, tender and contract review Sub-contracting of tests and calibrations Purchasing services and supplies Service to the client Complaints
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Control of nonconforming testing and/or calibration work Corrective action Preventive action Records Internal audits Management reviews

Management requirements

ISO17025 - General requirements for the competence of testing and calibration laboratories
General Personnel Accommodation and environmental conditions Test and calibration methods including sampling Method validation Equipment Measurement traceability Sampling Handling and transportation of test and calibration items Assuring the quality of test and calibration results Reporting the results

Technical requirements

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Quality system management

Generalitat de Catalunya Departament dAgricultura, Ramaderia i Pesca

The flow of our work

How do I get my work?
How many people involved Chain of custody Time frame for delivery Plan for handling the samples? Priority rules? Communications with the customer?

What do I do with the work when I get it?

What do I do with the work when Its done?

Follow up & communication
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Process map / Flow chart

PURPOSE INPUTS & OUTPUTS INDICATORS DOCUMENTS RECORDS ASSOCIATES PROCESS

SAMPLES

ANALYSIS
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REPORT

Correctness and reliability

Main factors:
human factors accommodation and environmental conditions test and calibration methods method validation equipment measurement traceability sampling handling of test and calibration items

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Quality Management System

Generalitat de Catalunya Departament dAgricultura, Ramaderia i Pesca

About quality...

K. Isikawa:
Quality control is applicable to any company and must be applied to all the company A company that does not practice quality control will not last Quality control fails when nobody understands it Quality control begins and finishes with education and training People show their true capacity when their abilities are used suitably and responsibility is given to them

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About quality...

K. Isikawa:
A company that does the inspection of 100 per 100 is a company that makes defective products Quality is not created by means of the inspection: it is obtained by means of the design and the process If the management get upset, angry, when defective units are produced, then the people will hide it The normalization allows authority to be delegated

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Advantages to work in accordance to a Quality Assurance System - Technical

CORRECTNESS and RELIABILITY

TRACEABILITY

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Advantages to work in accordance to a Quality Assurance System Organization

Generalitat de Catalunya Departament dAgricultura, Ramaderia i Pesca

SAME VISION IN FRONT THE SAME REALITY?

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Advantages of working with accordance to a Quality Assurance System Organization The laboratory shall

have managerial and technical personnel with the authority and resources needed to carry out their duties and to identify the occurrence of departures from the quality system. specify the responsibility, authority and interrelationships of all personnel who manage, perform or verify work affecting the quality of the tests and/or calibrations appoint a member of staff as quality manager (however named) who, irrespective of other duties and responsibilities, shall have defined responsibility and authority for ensuring that the quality system is implemented and followed at all times; the quality manager shall have direct access to the highest level of management at which decisions are taken on laboratory policy or resources
ISO17025 (4.1.4)
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Advantages of working in accordance with a Quality Assurance System Accreditation: Independent recognition that the laboratory is competent Give confidence to the customer Confidence to laboratory staff Fulfillment of legal framework

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Advantages of working in accordance with a Quality Assurance System

Document control:
Think over Unify

Management and technical records:

Traceability

Qualifications and competence:

Training - Deputies

Specifications control:
Cost - Quality

Equipment management:
Planning

Method validation:
Confidence in results

Generalitat de Catalunya Departament dAgricultura, Ramaderia i Pesca

Quality Management System Nonconforming work

Usual items of nonconforming work or problems with the quality system or with testing and/or calibration activities are related to:
customer complaints quality control instrument calibration checking of consumable materials staff observations or supervision test reports management reviews and internal or external audits
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Test final report

The Final Report shall include at least the following information
a title (e.g. "Test Report" ) name and address of laboratory unique identification of the test report (such as serial number), and on each page an identification in order to ensure that the page is recognized as a part of the test report name and address of the client placing the order description and unambiguous identification of the item(s) tested date of receipt of test item(s) and date(s) of performance of the test test results with units of measurement ...
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Test final report

The Final Report shall include at least the following information
reference to sampling procedures used by the laboratory or other bodies where these are relevant to the validity or application of the results the name, function and signature of person authorizing the test report a statement to the effect that the results relate only to the items tested a statement specifying that the test report shall not be reproduced except in full, without written approval of the laboratory.

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Test final report

Where necessary for the interpretation of the test results, include:
description and condition of the test item identification of the standardized test method(s) used, or unambiguous brief description of any non-standardized method used deviations from, additions to or exclusions from the test method, and information on specific test conditions, such as environmental conditions where relevant, a statement of compliance/non compliance with requirements and/or specifications where appropriate and needed, opinions and interpretations where applicable, a statement on the estimated uncertainty of measurement of the test result additional information required by specific branches.
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Equipment information
The records shall include at least the following:
identity of the item of equipment manufacturer's name, type identification, and serial number or other unique identification checks that equipment complies with the specification current location (if it where appropriate) the manufacturer's instructions, if available, or reference to their location dates, results and copies of reports and certificates of all calibrations, adjustments, acceptance criteria, and due date (or criteria) of next calibration maintenance carried out to date and the maintenance plan damage, malfunction, modification or repair to the equipment.
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Quality Management System

Generalitat de Catalunya Departament dAgricultura, Ramaderia i Pesca

How to establish the cause?

Ishikawa diagram
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ISO17025 - General requirements for the competence of testing and calibration laboratories

The laboratory management shall document its policies, systems, programmes, procedures and instructions to the extent necessary to enable the laboratory to assure the quality of the test and/or calibration results it generates.
9 ISO17025 4.2.1

Do what is written and write what you do

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Documentation structure

QM
Process

GP
SP
F F

GP
SP
F

SP
F

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ISO17025 - General requirements for the competence of testing and calibration laboratories

Raw data Recording General Procedures Specific Procedures ...

QUALITY ASSURANCE MANUAL SOP for SOPs

Generalitat de Catalunya Departament dAgricultura, Ramaderia i Pesca

Quality Management System

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Conclusions

The importance of: Working like a team. All the jobs are important. Organization Disciplined work Do what is written and write what you do Follow the Quality Assurance Unit indications Follow the well qualified technicians indications Being a good professional

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