Management System Requirements Part 1

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Management System RequirementsPart 1

• Tracey Noblett
• Quality Management

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Discussion

• History of PT accreditation in UK
• PT providers
• Management System requirements Part 1

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Accreditation of PT Providers

• Due to demand from PT providers and their
  participants
• Carried out by national accreditation body, UKAS
  (United Kingdom Accreditation Service).
• Accreditation to ISO 43-1, through assessment
  against ILAC G13 and incorporating relevant
  elements of ISO 17025 and ISO 9001.

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Accreditation of PT Providers

• UKAS developed PT accreditation mark.
• First accreditations of PT providers were in July
  2002.
• Presentation at London Zoo.

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Types of PT Providers

• Sector
• Size
• Distribution
• Scheme design
• Sample preparation and testing
• Frequency
• Participation

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LGC

• Primary business is analytical testing
• Established 1850s
• Publicly owned until 1996
• 780 Employees (7 in PT)
• 240 sample distributions
• 500 participating laboratories
• 60 Countries
• 9 Separate PT Schemes

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Quality Management

• Primary business is PT
• Established 1991
• Privately owned
• 35 Employees
• 500 sample distributions
• 3000 participating laboratories
• 80 Countries
• 17 Separate PT Schemes

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Management System Requirements Part 1

• Implementing a quality management system
• Establishing an organisational structure
• Controlling documents and records

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Implementing a quality management system

• Provider needs to establish, implement and
• maintain a quality management system
• appropriate to its scope of activities.

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Implementing a quality management system - LGC
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Implementing a quality management system - QM
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Implementing a quality management system

• Provider needs to establish, implement and
  maintain a quality management system appropriate
  to its scope of activities.
• Provider needs to define and document its policy,
  objectives and commitment to quality.

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Quality Policy - LGC
LGC is committed to continual improvement in
quality and efficiency through procedures based
upon quality assurance. This commitment is
demonstrated through LGCs certification to
ISO 90012000 for all its activities
accreditation to ISO 170252005 for the majority
of its analytical testing and all calibration
activities accreditation to ILAC G132000 and
ISO Guide 43 for the operation, management and
design of proficiency testing schemes and
compliance with GLP1999 for those parts of the
Laboratory carrying out registration and
environmental fate studies.
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Quality Policy - QM
In order to demonstrate the Companys confidence
in its systems, its commitment to its customers
and to its people, Quality Management maintains
registration to ISO 9001 2000 and accreditation
to ISO/IEC Guide 43-1 1997 through assessment
against ILAC G13 2000.
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Implementing a quality management system

• Provider needs to establish, implement and
  maintain a quality management system appropriate
  to its scope of activities.
• Provider needs to define and document its policy,
  objectives and commitment to quality.
• Format of the documented quality management
  system shall contain relevant information for
  operation of PT schemes.

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Implementing a quality management system
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Quality Procedures - LGC
QP1113 ORGANISATION MANAGEMENT OF PT
SCHEMES WI 1520 OPERATION OF BAPS WI 1522
OPERATION OF DAPS WI 1523 OPERATION OF
PHARMASSURE WI 1530 HOMOGENEITY TESTING
DISPATCH OF BAPS WI 1532 SAMPLE PREPARATION
DISPATCH OF DAPS WI 1541 LIASON WITH
COLLABORATORS SUB-CONTRACTORS WI 1542
PLANNING DESIGN OF PT SCHEMES WI 1543
PRODUCTION OF REPORTS WI 1544 POLICY FOR REVIEW
OF PT SCHEMES WI 1545 HANDLING OF PT
COMMUNICATIONS WI 1546 HOW TO PERFORM
HOMOGENEITY TESTING WI 1550 USE OF PT MANAGER
SOFTWARE
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Quality Procedures - QM

• SCHEME PLANNING AND DESIGN
• SCHEME ORGANISATION AND REVIEW
• ENQUIRIES, AGREEMENTS AND SCHEDULE
  DISTRIBUTION
• 4 SUPPLIER, SUB-CONTRACTOR AND COLLABORATOR
  APPROVAL
• AND MONITORING
• PURCHASING, RECEIPT OF ITEMS AND INITIAL
  STORAGE
• CALIBRATION AND MAINTENANCE OF EQUIPMENT
• LABORATORY ORGANISATION AND CONTROL
• MICROBIOLOGY LABORATORY OPERATIONS
• CHEMISTRY LABORATORY OPERATIONS

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Implementing a quality management system - QM

• 10 PRODUCT STORAGE, PACKING AND DESPATCH
• CONTROL OF NON-CONFORMING PRODUCT
• CONTROL OF PARTICIPANT DATA, ANALYSIS AND
  REPORTING
• CONTROL OF CONCERNS AND CUSTOMER COMPLAINTS
• BUSINESS REVIEW AND CORRECTIVE ACTIONS
• TRAINING
• CONTROL OF QUALITY SYSTEM MANUALS, DOCUMENTS
  AND DATA
• REFERENCE DOCUMENTS, EXTERNAL DOCUMENTS AND
  DATA CONTROL
• 18 QUALITY AUDIT

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Implementing a quality management system

• Establish, implement and maintain a quality
  management system appropriate to its scope of
  activities.
• Define and document its policy, objectives and
  commitment to quality.
• Format of the documented quality management
  system shall contain relevant information for
  operation of PT schemes.
• Define and control activities of collaborators
• Define roles and responsibilities of Technical
  Manager, Quality Manager and Scheme Co-ordinator
  (s).

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Scheme co-ordinators

• Customer service
• Despatch
• Reports
• Technical

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Use of Advisory Groups

• External or internal
• Selection of members
• Frequency format

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UKAS observations - Quality System

• For LGC, no need to separately assess Quality
  Manual and Corporate Quality Procedures.
• For QM, spend 50 of time assessing contents of
  Quality Manual and Quality Procedures.
• For QM, some overlap between ISO 9001 and ISO 43
  assessments.
• For QM, very high emphasis on ISO 17025 in
  laboratory audit.

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Organisation and Management

• The organisation shall be legally identifiable
• The provider shall define its organisation and
• management structure and responsibilities

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LGC Organisation

PT Group Manager
Scheme Manager
Operations Manager
Scheme Manager
Despatch assistant
Scheme Administrator
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QM organisation

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UKAS observations - Organisation and Management

• There must be clear distinction between roles
  of technical and quality manager, even if
  performed by same person.
• If quality manager covers two areas, e.g. PT
  and testing, there must be clearly differentiated
  roles responsibilities in the two fields.

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Summary