Koch, M.: Quality Manual© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching Quality Manual Michael Koch

Koch, M.: Quality Manual© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching Quality Manual – Why?  ISO/IEC states the necessity for an accredited laboratory to have a quality system with certain requirements as well as procedures to keep documents under control  The quality manual is the keystone of the documentation of a quality system.

Koch, M.: Quality Manual© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching Quality Manual  Contents  Document Control

Koch, M.: Quality Manual© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching Quality Manual – Contents ISO/IEC –  The laboratory shall establish, implement and maintain a quality system appropriate to the scope of its activities.  The laboratory shall document its policies, systems, programmes, procedures and instructions to the extent necessary to assure the quality of the test and/or calibration results.  The system’s documentation shall be communicated to, understood by, available to, and implemented by the appropriate personnel.

Koch, M.: Quality Manual© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching Quality Manual – Contents ISO/IEC –  The laboratory’s quality system policies and objectives shall be defined in a quality manual (however named).  The overall objectives shall be documented in quality policy statement.  The quality policy statement shall be issued under the authority of the chief executive.

Koch, M.: Quality Manual© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching Quality Manual – Contents ISO/IEC – (followed)  It shall include at least the following:  the laboratory management’s commitment to good professional practice and to the quality of its testing and calibration in servicing its clients;  the management’s statement of the laboratory‘s standard of service;  the objectives of the quality system;

Koch, M.: Quality Manual© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching Quality Manual – Contents ISO/IEC – (followed)  a requirement that all personnel concerned with testing and calibration activities within the laboratory familiarize themselves with the quality documentation and implement the policies and procedures in their work; and  the laboratory management’s commitment to compliance with this International Standard.

Koch, M.: Quality Manual© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching Quality Manual – Contents ISO/IEC –  The quality manual shall include or make reference to the supporting procedures including technical procedures.  It shall outline the structure of the documentation used in the quality system.

Koch, M.: Quality Manual© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching Quality Manual – Contents ISO/IEC –  The roles and responsibilities of technical management and the quality manager, including the responsibility for ensuring compliance with this International Standard, shall be defined in the quality manual.

Koch, M.: Quality Manual© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching Quality Policy  The quality policy is one of the essential things in a quality system.  the whole system should only reflect the quality policy in the daily work and put the policy into concrete terms  the policy shall be issued under the authority of the chief executive  It is very important to have a clear statement, how crucial quality is in the work of his/her laboratory

Koch, M.: Quality Manual© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching Quality Policy  Quality policy is very specific for each laboratory in the framework of its tasks, its role in a larger organization and its relationship to its customers.  There is no recipe for the formulation

Koch, M.: Quality Manual© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching Presentation of the Laboratory  Address  Phone, Fax,  Internet-Website  Ownership  Year of foundation  History  Bank account  Memberships in associations and organisations  Statement of independence from influences that may adversely affect the quality of the work  Cooperation with other laboratories and organizations …… This chapter should contain:

Koch, M.: Quality Manual© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching Organization and Management  Names of persons responsible for commercial management  Names of persons responsible for technical management  including a short description of the qualification of the technical manager and his deputy  Organization chart

Koch, M.: Quality Manual© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching Organization Chart

Koch, M.: Quality Manual© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching Quality Manager  The laboratory must have a quality manager (and if possible a deputy)  The name and responsibilities/duties have to be stated here  The quality manager must have direct access to the highest level of management at which decisions are made on laboratory policy or resources

Koch, M.: Quality Manual© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching Staff  number of employees  names of persons responsible for subdivisions  reference, where information for all technical staff is documented concerning  relevant authorizations  competence  educational and professional qualifications  training (in the past and plans for the future)  skills  experience

Koch, M.: Quality Manual© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching Allocation of Responsibilities  For signing contracts  For signing test reports  For acquisition  For procurement

Koch, M.: Quality Manual© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching List of Signatures  For all relevant staff

Koch, M.: Quality Manual© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching Administration, Access and Review of the Quality Manual  All staff must have access to the quality manual.  This access must be managed  All copies must be current versions  The quality manual must be regularly reviewed  All these things are the duties of the quality manager

Koch, M.: Quality Manual© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching Standard Operation Procedures  There have to be standard operation procedures for all relevant procedures  It is useful to have the SOPs in separate documents  The quality manual should contain a list of available SOPs

Koch, M.: Quality Manual© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching Standard Operation Procedure – Content - I  general description of the method  underlying standard  sampling and conservation  range of application  interferences  necessary equipment  chemicals (purity, where to buy)  measurement

Koch, M.: Quality Manual© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching Standard Operation Procedure – Content - II  calibration  evaluation  control charts  other quality assurance measures  use of reference materials  presentation of results  limit of detection, limit of determination  responsibilities

Koch, M.: Quality Manual© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching Standard Operation Procedure – Standardised Methods  A standard can not cover the laboratory specific details  equipment  supplier  trained staff  responsibilities  QA measures  limit of detection,...  These details have to be documented  The extent of the SOP depends on the qualification of the staff

Koch, M.: Quality Manual© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching Other Guidelines  If the laboratory has other guidelines, they should be included or referenced in the quality manual  for calibration  for calculation of detection limits  for calculation and construction of control charts  for...

Koch, M.: Quality Manual© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching Reference Materials  The laboratory should keep a list of reference materials used  This list has to be in the quality manual  or a note where the RM‘s are listed

Koch, M.: Quality Manual© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching Accommodation and Environmental Conditions  ISO/IEC contains requirements for accommodation and environmental conditions  Their fulfilment must be described in the quality manual  Description of the rooms  Floor plan

Koch, M.: Quality Manual© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching Equipment  There must be records on each item of equipment and its software significant to tests and/or calibration performed  Usually on separate documents  List of all records  (Guideline, what has to be recorded)

Koch, M.: Quality Manual© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching Defect and Incorrect Working Test Equipment  Equipment that has been shown to be defective or outside specified limits must be taken out of service  There must be regulations in the quality manual  how the equipment has to be labeled  what must be arranged

Koch, M.: Quality Manual© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching Internal Audits  Internal Audits can show that the operation of the laboratory is in compliance with its quality system and with ISO/IEC  Schedule  Prescribed procedure  Schedule and procedure must be documented in the quality manual

Koch, M.: Quality Manual© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching Management Review  A management review can show the continuing suitability and effectiveness of the quality system and of the testing activities  Schedule  Prescribed procedure  Schedule and procedure must be documented in the quality manual

Koch, M.: Quality Manual© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching Interlaboratory Tests  Participation in interlaboratory test should be a matter of course for each laboratory in its testing field  Planning  Results  Corrective actions

Koch, M.: Quality Manual© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching Complaints  Policy and procedure for the handling of complaints  from clients  from other parties

Koch, M.: Quality Manual© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching Document Control - General ISO/IEC –  The laboratory shall establish and maintain procedures to control all documents that form part of its quality system (internally generated or from external sources), such as  regulations,  standards,  other normative documents,  test and/or calibration methods, as well as  drawings,  software,  specifications,  instructions and  manuals.

Koch, M.: Quality Manual© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching Document Control System  Every document must be clearly identified in the control system  together with its revision status  this can be done e.g. by a numbering system that includes the revision (e.g. SOP-SA ) standard operation procedure soil analysis No 132rev. 3.1

Koch, M.: Quality Manual© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching Document Approval and Issue ISO/IEC –  All documents issued to personnel in the laboratory as part of the quality system shall be reviewed and approved for use by authorized personnel prior to issue.  A master list or an equivalent document control procedure identifying the current revision status and distribution of documents in the quality system shall be established and be readily available to preclude the use of invalid and/or obsolete documents.

Koch, M.: Quality Manual© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching Master List  There can be e.g. a master list of all valid documents together with their revision status in the quality manual (or in a separate document)

Koch, M.: Quality Manual© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching Document Approval and Issue ISO/IEC –  The procedure(s) adopted shall ensure that:  authorized editions of appropriate documents are available at all locations where operations essential to effective functioning of the laboratory are performed;  documents are periodically reviewed and, where necessary, revised to ensure that continuing suitability and compliance with applicable requirements;  invalid or obsolete documents are promptly removed from all points of issue or use, or otherwise assured against unintended use;  obsolete documents retained for either legal or knowledge preservation purposes are suitably marked.

Koch, M.: Quality Manual© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching Availability  Authorized copies of the quality manual should be available  in the quality manager‘s office  in the laboratory manager‘s office  in the laboratory for all staff

Koch, M.: Quality Manual© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching Obsolete Documents  have to be removed immediately  it must be assured, that they are removed in all authorized copies  obsolete documents must be marked  but they have to be retained for  legal purposes  knowledge preservation

Koch, M.: Quality Manual© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching Document Approval and Issue ISO/IEC –  Quality system documents generated by the laboratory shall be uniquely identified.  Such identification shall include  the date of issue and/or  revision identification,  page numbering,  the total number of pages or a mark to signify the end of the document, and  the issuing authority(ies).

Koch, M.: Quality Manual© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching Document Changes ISO/IEC –  Changes to documents shall be reviewed and approved by the same function that performed the original review unless specifically designated otherwise.  The designated personnel shall have access to pertinent background information upon which to base their review and approval.

Koch, M.: Quality Manual© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching Document Changes ISO/IEC –  Where practicable, the altered or new text shall be identified in the document or the appropriate attachments.

Koch, M.: Quality Manual© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching Document Changes ISO/IEC –  If the laboratory’s documentation control system allows for the amendment of documents by hand pending the re-issue of the documents, the procedures and authorities for such amendments shall be defined.  Amendments shall be clearly marked, initialled and dated.  A revised document shall be formally re- issued as soon as practicable.

Koch, M.: Quality Manual© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching Document Changes ISO/IEC –  Procedures shall be established to describe how changes in documents maintained in computerized systems are made and controlled

Koch, M.: Quality Manual© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching Header of the Quality Manual  at least on the first page of each chapter:  identification of the laboratory  a statement that this is a part of the quality manual  number of the chapter  title of the chapter

Koch, M.: Quality Manual© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching Header of the Quality Manual  on each page of each chapter:  date of issue  revision number  name of author  eventually name of person, who checked the content  approval notice  page number  total number of pages of the chapter

Koch, M.: Quality Manual© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching Example – Top and Bottom of a Quality Manual Page Quality Manual Quality Policy chapter: 1 revision: 1 page 1 of 3 author:checked:approved:date of issue: Laboratory Logo

Koch, M.: Quality Manual© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching Structure of the Quality Manual  It is up to the author of the quality manual to decide about the detailed structure of “his” quality manual.  But it is extremely useful to separate it in chapters, which can be revised separately without revising and renumbering the whole manual.