QM0204_Quality System Documentation_Widiastuti Setyaningsih

8/6/2019 QM0204_Quality System Documentation_Widiastuti Setyaningsih

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Widiastuti Setyaningsih and Mohamed Yahia

European Master in Quality Analytical in Laboratory

University of Barcelona

Email [email protected]

[email protected]

1

Deadline : March 02, 2011

Prepared by : Widiastuti Setyaningsih and Mohamed Yahia

Supervised by : Professor Monserrat Llaurado

QM0204QUALITY SYSTEM DOCUMENTATION

TABLE OF CONTENT

1. Introduction-Presentation of the Laboratory ..... 22. Structure of the Documents of the QMS... 33. List of Documents of the Quality System Documentation (QSD) .. 44. Document or Documents Related to the Control of Documentation ... 125. Cover Page for Validation Sheet and Controlling the Document Applied for Any Kind of Documentation .. 136. SOP for the Document or Documents Related to the Control of Documentation 157. Example of Check Sheet for the Document or Forms Related to the Control of Documentation 228. References . 27


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1. INTR

WM Analyti

food matrice

requirements

WM analytical laboratory was estab

approximately 100 samples per week

people and continual improvement of

WM analytical laboratorys general o

authorities along with a detailed organ

Figure 1

The Internal Audit

This report focuses on the elaborati

preparing an accreditation process ac

newly developed and validated met

Residues in Milk Using Ultra High P

Switching. The method was develop

Ad

External

Auditor

Widiastuti Setyanin

European M

Em

DUCTION- PRESENTATION OF THE LABOR

al Laboratory is a premier company specialized in t

. The laboratory works under the Quality First pri

of national and international standards and regulation.

lished in February 2010 in Jakarta, Indonesia. It h

. The laboratory is committed to exceed costumers

its management system.

ganization chart is presented in Figure 1 below. Job d

izational chart are found in the document WM/TR/PE

WM Analytical Laboratorys Organizational Ch

r is subcontracted as stated in the corresponding quali

n of the quality management system (QMS) of an

ording to the requirements of the ISO/IEC 17025 st

hod coded as WM/TR/CV/AM/01 entitled Deter

rformance Liquid ChromatographyTandem Mass S

d and validated by the WM team composed of a very

Director

Quality

anager

inistrator

Technical

Manager

Analysts Technician

sih and Mohamed Yahia

ster in Quality Analytical in Laboratory


il [email protected]

[email protected]

2

ATORY

he analysis of drug residues in

nciple and is sincerely fulfilling

.

as 25 employees and receives

satisfaction, development of its

escriptions, responsibilities and

/S/07.

rt.

ty procedure

analytical laboratory which is

ndard. The accreditation of the

ination of Anthelmintic Drug

ectrometry with Rapid Polarity

competent analyst.

Financial

Manager

Receptionist Accountant


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STRUCTURE OF THE DO

WM have a coding system in place w

five parts and it contains the followin

The first part identifies that t The second part indicates if i The third part is the two or th The fourth part indicates if in The fifth part indicates the ru

Example: Code for the SOP in perfor

Note:

WM Name of the Laboratory

MR Management Requirement

DC Document Control

SOP Standard Operational Procedure

01 Running Number

And below is the Structure of the Doc

Requireme

Missi

Includes Quality Policies

Describes the

Additional Details which are

Evidence of Compliance to The

WM MR DC

Widiastuti Setyanin

European M

Em

CUMENTS OF THE QUALITY SYSTEM DOCU

hich is according to the structure of ISO-17025. Codi

information.

e document belongs to the WM Accredited Analytic

t is Management Requirement or a Technical Require

ree letter abbreviation of the sections of ISO 17025.

dicates if its an SOP, forms, work instruction, etc.

nning series number.

ing document control.

umentation System Applied in WM Accredited Labor

ISO/IEC 17025nts for Competence of Testing and Calibration Labor

Quality Policy and Quality Strategy

n Statement and How the Policies are implemented

Quality Manual

and Strategies of Intent for Meeting Applicable Stan

Testing Procedures

Detail of How Processes Which Affect Quality Are Car

Work Instructions and Forms

escribe How The Specific Jobs are Carried Out and C

Quality Records

equirements of ISO 17025 and WM laboratory Proce

SOP 01

sih and Mohamed Yahia

ster in Quality Analytical in Laboratory


il [email protected]

[email protected]

3

MENTATION (QSM)

ng of documents is broken into

l Laboratory.

ent

atory

tory

ard Requirements

ried Out

eck Sheet for a Process

dures and Test Instruction


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LIST OF DOCUMENTS OF THE QUALITY SYSTEM DOCUMENTATION (QSD)TO OBTAIN THE ACCREDITATION

Presented below is the master list identifying the documents in the management system which are classified according to

the section of ISO/IEC 17025.

Applicable ISO/IEC

17025:2005 clause(s)Document Code

4. Management Requirements

4.2Management

system

Quality policy

Quality strategy

Quality manual

WM/MR/MS/QP/01

WM/MR/MS/QS/01

WM/MR/MS/QM/01

4.3Document

control

SOP: document control

WI: document approval and issue

WI: document changes

Form: document control

WM/MR/DC/SOP/01

WM/MR/DC/WI/01

WM/MR/DC/WI/02

WM/MR/DC/F/01

4.4

Review of

requests, tenders

and contracts

SOP: reviewing the requests, tenders and contracts

WI: reviewing the requests, tenders and contracts

F: recording the review

WM/MR/RE/SOP/01

WM/MR/RE/WI/01

WM/MR/RE/F/01

4.5 SubcontractingProcesses

SOP: subcontracting processes

WI: subcontracting processes

F: recording the subcontracting processes

WM/MR/SP/SOP/01

WM/MR/SP/WI/01

WM/MR/SP/F/01

4.6

Purchasing

services and

supplies

SOP: procurement

SOP: reception and storage of purchased items

SOP: evaluating suppliers of critical supplies and services

WI: procurement, reception and storage the purchased items

Specification: HPLC-Grade Methanol (MeOH)

Specification: HPLC-Grade Acetonitrile (MeCN)

Specification: Deuterated MeOH

Specification: Ammonium Formate (Puriss Pro Analysis)

Specification: DMSO (Analytical Grades)

Specification: Isopropil Alcohol

Specification: Glacial Acetic Acid (HOAc)

Specification: Premix 1 (Anh. MgSO4 and NaCl)

Specification: Premix 2 (Anh. MgSO4 and C18)

Specification: Water Purification System (Millipore)

Specification: Glass Dispenser (Dispensette III, Brand)

Specification: Centrifuge (Mistral 3000i)

WM/MR/PP/SOP/01

WM/MR/PP/SOP/02

WM/MR/PP/SOP/03

WM/MR/PP/WI/01

WM/MR/PP/S/01

WM/MR/PP/S/02

WM/MR/PP/S/03

WM/MR/PP/S/04

WM/MR/PP/S/05

WM/MR/PP/S/06

WM/MR/PP/S/07

WM/MR/PP/S/08

WM/MR/PP/S/09

WM/MR/PP/S/10

WM/MR/PP/S/11

WM/MR/PP/S/12


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Applicable ISO/IEC

17025:2005 clause(s)Document Code


Specification: Multi Vortexer

Specification: Evaporator (Turbolap LV)

Specification: Ultrasonic Bath (Transsonic 780LH)

Specification: UPLC (Waters, Milford)

Specification: Spectrometer

Form: procurement record

WM/MR/PP/S/13

WM/MR/PP/S/14

WM/MR/PP/S/15

WM/MR/PP/S/16

WM/MR/PP/S/17

WM/MR/PP/F/01

4.7Costumer

Service

SOP: customer service

WI: customer service

External Memo

WM/MR/CS/SOP/01

WM/MR/CS/WI/01

WM/MR/CS/EM/01

4.8 Complaints

SOP: complaint

WI: complaint

Notification

WM/MR/CO/SOP/01

WM/MR/CO/WI/01

WM/MR/CO/N/01

4.9

Control of Non-

Conforming test/

calibration work

SOP: Controlling the nonconforming testing and/or calibration work

WI: Controlling the nonconforming testing and/or calibration work

Form: Controlling nonconforming testing and/or calibration work

WM/MR/CN/SOP/01

WM/MR/CN/WI/01

WM/MR/CN/F/01

4.10 Improvement SOP: improving the effectiveness of management system WM/MR/I/SOP/01

4.11 Corrective action

SOP: correction action

SOP: Selection and implementation of corrective actions

SOP: Monitoring of corrective actions

Form: corrective action

WM/MR/CA/SOP/01

WM/MR/CA/SOP/01

WM/MR/CA/SOP/01

WM/MR/CA/F/01

4.12Preventive

Action

SOP: preventive action

WI: preventive action

Form: preventive action

WM/MR/PA/SOP/01

WM/MR/PA/WI/01

WM/MR/PA/F/01

4.13Control of

Records

SOP : control of recordsWI : identification of quality and technical records

WI : collection of quality and technical records

WI : indexing of quality and technical records

WI : access of quality and technical records

WI : filing of quality and technical records

WI : storage of quality and technical records

WI : maintenance of quality and technical records

WI : disposal of quality and technical records

WI : protect and back-up records stored electronically

WI : prevent unauthorized access or change the records.

WM/MR/CR/SOP/01WM/MR/CR/WI/01

WM/MR/CR/WI/02

WM/MR/CR/WI/03

WM/MR/CR/WI/04

WM/MR/CR/WI/05

WM/MR/CR/WI/06

WM/MR/CR/WI/07

WM/MR/CR/WI/08

WM/MR/CR/WI/09

WM/MR/CR/WI/10


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Applicable ISO/IEC17025:2005 clause(s)

Document Code


4.14 Internal audits

SOP: internal audit

WI: internal audit

Form: internal audit check list

WM/MR/IA/SOP/01

WM/MR/IA/WI/02

WM/MR/IA/F/01

4.15Management

Reviews

SOP: management review

WI: management review

Form: management review

WM/MR/MR/SOP/01

WM/MR/MR/WI/01

WM/MR/MR/F/01

5. Technical requirements

5.2 Personnel

SOP: recruitment

Specification: qualifications and training programmes

Specification: managerial duties

Specification: responsibilities to performing tests or calibrations

Specification: responsibilities to the planning of tests and/or

calibrations and evaluation of results

Specification: responsibilities for reporting opinions

and interpretations

Specification: responsibilities to method modification and

development and validation of new methodsStructure of the Laboratory Organization

WM/TR/PE/SOP/01

WM/TR/PE/S/01

WM/TR/PE/S/02

WM/TR/PE/S/03

WM/TR/PE/S/04

WM/TR/PE/S/05

WM/TR/PE/S/06

WM/TR/PE/S/07

5.3

Accommodation

&environmental

Conditions

SOP: monitor, control and record environmental conditions

Specification: accommodation & environmental conditions

Form: conditions monitoring

WM/TR/AE/SOP/01

WM/TR/AE/S/01

WM/TR/AE/F/01

5.4

Test and

calibration

methods and

method

validation

SOP: Determination of anthelmintic drug residues in milk

using UPLC-MS with rapid polarity switching

SOP: selection of methods

SOP: laboratory-developed methods

SOP: non-standard methodsSOP: method validation: determination of anthelmintic drug

residues in milk by UPLC-MS with rapid polarity switching

SOP: estimation of uncertainty of measurement

WM/TR/CV/SOP/01

WM/TR/CV/SOP/02

WM/TR/CV/SOP/03

WM/TR/CV/SOP/04WM/TR/CV/SOP/05

WM/TR/CV/SOP/06

SOP: control of data WM/TR/CV/SOP/07

SOP: equipment calibration of UPLC (Waters, Milford)

SOP: equipment calibration of Volumetric Glass

SOP: equipment calibration of Analytical Balance

SOP: software calibration of UHPC-MS/MS controlling

SOP : software UHPC-MS/MS data processing

WM/TR/CV/SOP/08

WM/TR/CV/SOP/09

WM/TR/CV/SOP/10

WM/TR/CV/SOP/11

WM/TR/CV/SOP/12


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Document Code


5.4

Test,

calibrationmet

hods, and

method

validation

WI: Preparation of Ultrapure Water

WI: Preparation of Primary Stock Standard Solutions

WI: Preparation of Internal Standard

WI: Preparation of Avermectins

WI: Preparation of TCB Metabolites

WI: Preparation of Benzimidazoles

WI: Preparation of Intermediate Working Standard

WI: Preparation of Working Internal Standard Mix Solutions

WI: Preparation of Extracted Matrix Calibrants Solution

WI: Preparation of Matrix Matched Calibrants Solution

WI: Preparation of Blank Matrix Samples

Form: Testing

Form: Calibration

Report: Validation

WM/TR/CV/WI/01

WM/TR/CV/WI/02

WM/TR/CV/WI/03

WM/TR/CV/WI/04

WM/TR/CV/WI/05

WM/TR/CV/WI/06

WM/TR/CV/WI/07

WM/TR/CV/WI/08

WM/TR/CV/WI/09

WM/TR/CV/WI/10

WM/TR/CV/WI/11

WM/TR/CV/F/01

WM/TR/CV/F/02

WM/TR/CV/R/01

5.5 Equipment

SOP: equipment maintenance

SOP: equipment control and inventoryUser Manual: Water Purification System (Millipore)

User Manual: Glass Dispenser (Dispensette III, Brand)

User Manual: Centrifuge (Mistral 3000i)

User Manual: Multi Vortexer

User Manual: Evaporator (Turbolap LV)

User Manual: Ultrasonic Bath (Transsonic 780LH)

User Manual: UPLC (Waters, Milford)

User Manual: Spectrometer

WI: Water Purification System (Millipore)

WI: Glass Dispenser (Dispensette III)

WI: Centrifuge (Mistral 3000i)

WI: Multi Vortexer

WI: Evaporator (Turbolap LV)

WI: Ultrasonic Bath (Transsonic 780LH)

WI: UPLC (Waters, Milford)

WI: Spectrometer

WI: UHPC-MS/MS Controlling (MassLynxTM)

WI: UHPC-MS/MS Data Processing (TargetLynxTM)

WM/TR/E/SOP/01

WM/TR/E/SOP/02WM/TR/E/UM/01

WM/TR/E/UM/02

WM/TR/E/UM/03

WM/TR/E/UM/04

WM/TR/E/UM/05

WM/TR/E/UM/06

WM/TR/E/UM/07

WM/TR/E/UM/08

WM/TR/E/WI/01

WM/TR/E/WI/02

WM/TR/E/WI/03

WM/TR/E/WI/04

WM/TR/E/WI/05

WM/TR/E/WI/06

WM/TR/E/WI/07

WM/TR/E/WI/08

WM/TR/E/WI/09

WM/TR/E/WI/10


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Document Code


5.6Measurement

traceability

SOP: traceability in calibration

SOP: traceability in testing

RMC: Abamectin (ABA)

RMC: Albendazole (ABZ)

RMC: Bithionol (BITH)

RMC: Clorsulon (CLOR)

RMC: Closantel (CLOS)

RMC: Coumaphos (COUM)

RMC: Doramectin (DORA)

RMC: Emamectin (EMA)

RMC: Fenbendazole (FBZ)

RMC: Haloxon (HAL)

RMC: Ivermectin (IVER)

RMC: Levamisole (LEVA)

RMC: Morantel (MOR)

RMC: Niclozamide (NICL)RMC: Nitroxynil (NITR)

RMC: Oxfendazole (OFZ)

RMC: Oxyclozanide (OXY)

RMC: Rafoxanide (RAF)

RMC: Thiabendazole (TBZ)

RMC: Albendazole-2-amino-sulphone (ABZ-NH2 -SO2 )

RMC: Albendazole-sulphone (ABZ-SO2 )

RMC: Albendazole-sulphoxide (ABZ-SO)

RMC: Amino-oxibendazole (OXI-NH2 )RMC: 5-hydroxy-thiabendazole (5-OH-TBZ)

RMC: Fenbendazole-sulphone (FBZ-SO2 )

RMC: Triclabendazole (TCB)

RMC: Triclabendazole-sulphone (TCB-SO2 )

RMC: Triclabendazole-sulphoxide (TCB-SO)

RMC: Coumaphos-oxon (COUM-O)

RMC: Cambendazole (CAM)

RMC: Oxibendazole (OXI)

RMC: Amino-flubendazole (FLU-NH2 )

WM/TR/MT/SOP/01

WM/TR/MT/SOP/02

WM/TR/MT/RMC/01

WM/TR/MT/RMC/02

WM/TR/MT/RMC/03

WM/TR/MT/RMC/04

WM/TR/MT/RMC/05

WM/TR/MT/RMC/06

WM/TR/MT/RMC/07

WM/TR/MT/RMC/08

WM/TR/MT/RMC/09

WM/TR/MT/RMC/10

WM/TR/MT/RMC/11

WM/TR/MT/RMC/12

WM/TR/MT/RMC/13

WM/TR/MT/RMC/14WM/TR/MT/RMC/15

WM/TR/MT/RMC/16

WM/TR/MT/RMC/17

WM/TR/MT/RMC/18

WM/TR/MT/RMC/19

WM/TR/MT/RMC/20

WM/TR/MT/RMC/21

WM/TR/MT/RMC/22


WM/TR/MT/RMC/25

WM/TR/MT/RMC/26

WM/TR/MT/RMC/27

WM/TR/MT/RMC/28

WM/TR/MT/RMC/29

WM/TR/MT/RMC/30

WM/TR/MT/RMC/31

WM/TR/MT/RMC/32


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Document Code


5.6Measurement

traceability

RMC: Hydroxy-flubendazole (FLU-OH)

RMC: Hydroxy-mebendazole (MBZ-OH)

RMC: Flubendazole (FLU)

RMC: Mebendazole (MBZ)

RMC: Eprinomectin (EPR)

RMC: Moxidectin (MOXI)

RMC: Albendazole-D3 (ABZ-D3)

RMC: Albendazole-sulphone-D3 (ABZ-SO2 -D3)

RMC: Albendazole-sulphoxide-D3 (ABZ-SO-D3)

RMC: Fenbendazole-D3 (FBZ-D3)

RMC: Fenbendazole-sulphone-D3 (FBZ-SO2 -D3)

RMC: Levamisole-D5 (LEVA-D5)

RMC: Mebendazole-D3 (MBZ-D3)

RMC: Thiabendazole-D3(TBZ-D3)

RMC: Triclabendazole-D3 (TCB-D3)

RMC: Albendazole-2-amino-sulphone-D2 (ABZ-NH2-SO2 D2RMC: Selamectin (SELA)

RMC: Salicylanilide (SALI)

RMC: 4-Nitro-3-(trifluoromethyl)phenol (TFM)

RMC: Ioxynil (IOX)

RMC: Amino-triclabendazole (TCB-NH2 )

WM/TR/MT/RMC/34

WM/TR/MT/RMC/35

WM/TR/MT/RMC/36

WM/TR/MT/RMC/37

WM/TR/MT/RMC/38

WM/TR/MT/RMC/39

WM/TR/MT/RMC/40

WM/TR/MT/RMC/41

WM/TR/MT/RMC/42

WM/TR/MT/RMC/43

WM/TR/MT/RMC/44

WM/TR/MT/RMC/45

WM/TR/MT/RMC/46

WM/TR/MT/RMC/47

WM/TR/MT/RMC/48


WM/TR/MT/RMC/51

WM/TR/MT/RMC/52

WM/TR/MT/RMC/53

WM/TR/MT/RMC/54

5.7 Sampling

SOP: sampling procedure

WI: sampling scheme, sampling drawing, sampling instruction

Form: sampling

WM/TR/SA/SOP/01

WM/TR/SA/WI/02

WM/TR/SA/F/01

5.8

Handling of

test and

calibration

items

SOP: transportation, receipt, handling, protection, storage,retention and/or disposal of test and/or calibration item

SOP: identifying test and/or calibration items.

SOP: handling of test and calibration items

Form: test and calibration condition recording

WM/TR/TC/SOP/01

WM/TR/TC/SOP/02

WM/TR/TC/SOP/03

WM/TR/TC/F/01

5.9

Assuring the

quality of test

and

calibrationresults

SOP: quality control for calibration

SOP: monitoring the validity of tests

SOP: regular use of CRM and/or internal quality control using

secondary RM

SOP: proficiency-testing programs

WM/TR/AQ/SOP/01

WM/TR/AQ/SOP/02

WM/TR/AQ/SOP/03

WM/TR/AQ/SOP/04


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Document Code


5.10Reporting the

Results

SOP: reporting the test reports and calibration certificates

SOP: reporting the analysis reports

SOP: generating the calibration certificates

SOP: defining the opinions and interpretations

SOP: reporting the testing and calibration results obtained

from subcontractors

SOP: reporting by electronic transmission of results

WM/TR/RR/SOP/01

WM/TR/RR/SOP/02

WM/TR/RR/SOP/03

WM/TR/RR/SOP/04

WM/TR/RR/SOP/05

WM/TR/RR/SOP/06

Note : Raws with light blue shadow are the document or documents related to the control of documentation

4.2 MANAGEMENT SYSTEM

4.2.1 Management System consisting of Quality Manual, test procedures, work instructions, forms, reports etc. as per

requirements of ISO/IEC-17025-2005 and WM Acreedited Laboratory requirements has been established,

implemented and is being maintained at all the levels in the laboratory. Management ensures Management System

documentation of the laboratory is communicated to, understood by, available with and is implemented by thosepersonnel who are responsible for maintaining the quality of test.

4.2.2 (a,b,c,d) To achieve the Quality Policy, Objectives and Quality Planning is evolved. Management will be committed

to ensure that the quality policy is understood, implemented and maintained by the personnel at all levels of the

organization.

The quality policy is displayed prominently at appropriate locations in the laboratory. The employees are educatedabout the quality policy and their role and responsibilities towards achieving it. The quality policy is relevant to the

management organizational goals and needs of the customer. It complies with the international standards of

ISO/IEC 17025-2005.

The effective implementation of the quality policy is monitored by key managerial personnel on day to day basis

and through internal quality audits and periodic management review meetings. All personnel are committed to

implement and maintain the quality policy. Quality Policy can be reviewed for its continuing suitability during

Management Review Meeting, if required.

4.2.2 (e) Management will be committed to comply with ISO/IEC-17025-2005 standard and to continually improve the

effectiveness of the management system

4.2.3 The WM Accredited laboratory has established, documented, implemented and is maintaining a ManagementSystem. Quality Manager maintains the records to provide evidence of conformity to requirements and

effectiveness of the Management System established. Such records comprise of:-

a) Achievement of Quality :-- Inspection Report- Test Data- Supplier Assessment Report- Corrective Action Report- Preventive Action Report- Training Record- Improvement Record

b) System Effectiveness :-- Internal Audit Report- Minutes of Management Review Meeting- Customer Feed Back, Complaints and Suggestions received


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4.2.4 Quality Manager ensures the promotion of awareness of customer requirement in the Organization. The mainconsideration of the laboratory to meet the importance of customer requirement, statutory requirement and

regulatory requirement are :-

- The identification of process and determination of their sequence and interaction needed forManagement System and their application.

- To ensure the availability of resources and information necessary to support the operation andmonitoring to these process.

Laboratory has procured all documents related to statutory and regulatory bodies relevant to scope of work.

4.2.5 The Management System is being implemented with the support of following documents.

Level I Quality Manual Level II Management System Procedure Level III Standard Operating Procedure Level IV Work Instruction ManualResponsibilities related to various documents of the Management System are given below. The actual systems

that are implemented are described in relevant sections.

4.2.6 The roles and responsibilities of Technical Manager and Quality Manager are defined under clause 4.1.4. In case

of absence of Quality Manager, Technical Manager shall take the additional responsibility of Quality Managerand vice-versa. In case of absence of both Lab In-charge shall take the responsibility of the duties of Quality

Manager and Team Manager.

4.2.7 The integrity of the management system is maintained through documents maintained as per MSP/05.

.

DOCUMENT OR DOCUMENTS RELATED TO THE CONTROL OF DOCUMENTATION

Applicable ISO/IEC

17025:2005 clause(s) Document Code

4.3 Document

control

SOP: document control

WI: document approval and issue

WI: document changes

Form: document control

WM/MR/DC/SOP/01

WM/MR/DC/WI/01

WM/MR/DC/WI/02

WM/MR/DC/F/01

4.13 Control of

Records

SOP : control of records

WI : identification of quality and technical records

WI : collection of quality and technical records

WI : indexing of quality and technical records

WI : access of quality and technical recordsWI : filing of quality and technical records

WI : storage of quality and technical records

WI : maintenance of quality and technical records

WI : disposal of quality and technical records

WI : protect and back-up records stored electronically

WI : prevent unauthorized access or change the records.

WM/MR/CR/SOP/01

WM/MR/CR/WI/01

WM/MR/CR/WI/02

WM/MR/CR/WI/03

WM/MR/CR/WI/04WM/MR/CR/WI/05

WM/MR/CR/WI/06

WM/MR/CR/WI/07

WM/MR/CR/WI/08

WM/MR/CR/WI/09

WM/MR/CR/WI/10

5.4Test & calibrationmethods & method

validation

SOP: control of data

WI: control of data

Form: control data

WM/TR/CV/SOP/07

WM/TR/CV/WI/07

WM/TR/CV/F/07


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COVER PAGE FOR VALIDATION SHEET AND CONTROLLING THE DOCUMENTAAPLIED FOR ANY KIND OF DOCUMENTATION

WM ACCREDITED

LABORATORY

Document No.

WM/XX/XX/XX/XX

Copy number: 00XX

Issue number : 00XX

Issued to:

Date: XX.XX.XXXX

Page X of XDoc. Effective Date

XX.XX.XXXX

VALIDATION SHEET AND CONTROLLING

-TYPE OF DOCUMENT-

-DOCUMENTATION-

No. of Copy :Distribute to :Date of Distribution :

Distribution Status : Controlled Document

Uncontrolled DocumentNote. Give mark to the suitable one

This system procedure is published for internal usage of MW Accredited LaboratoryRestricted to copy this document without written permission from MW Accredited Laboratory

Prepared By Checked By Approved By


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WM ACCREDITED

LABORATORY

Document No.

WM/XX/XX/XX/XX

Copy number: 00XX

Issue number : 00XX

Issued to:

Date: XX.XX.XXXX

Page X of XDoc. Effective Date

XX.XX.XXXX

CHECK SHEET FOR DOCUMENTS CHANGES

Section No. Improvement Published Date Improved No. Improved Date Signature


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SOP FOR THE DOCUMENT OR DOCUMENTSRELATED TO THE CONTROL OF DOCUMENTATION

These Standard Operational Procedures (SOPs) are prepared by WM Accredited laboratory to describe the detailed

information about the control of documentation which is complying with ISO/IEC 175025 standard.

Applicable ISO/IEC 17025:2005 clause : (4. 3) Document Control

Title:

DOCUMENT AND RECORD

CONTROL

Document No.

WM/MR/DC/SOP/01

Copy number: 001

Issue number : 001

Issued to:

All Department

Date: 21.07.2010

Page 1 of 2

Doc. Type

SOP

Prepared by:

Administrator

Widiastuti Setyaningsih

Approved by:

Quality Manager

Mohamed Yahia

Effective Date

21.07.2010

Controlled Document

1.PurposeValid documents will be available at all places of usage by appropriate control of documents so that the

Management System can be implemented and maintained.

2.ScopeThe documents used in the operation of the Management System will be controlled and issued after reviewingfor their total adequacy and approved by the authority.

3.References01 WM/MR/DC/WI/01

02 WM/MR/DC/WI/02

03 WM/MR/DC/F/01

4.Procedure PICA. Management System Establishment

01 Management System Quality Manager

The laboratory has established procedures to control all documents that form part of Management

System and existing regulations.

B. Document Approval and Issue

01 Approval and Issue of Controlled Documents Quality Manager

All the controlled documents are periodically reviewed by QM and Approved by Director and

issued by Quality Manager. Records of amendment/revision and obsolete documents are

maintained as defined in WM/MR/DC/WI/01. Issue record of QM, QSP, SOP, WIM and Raw data

notebooks are also maintained and record in WM/MR/DC/F/01.


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Title:DOCUMENT AND RECORD

CONTROL

Document No.WM/MR/DC/SOP/01

Copy number: 001Issue number : 001

Issued to:

All Department

Date: 21.07.2010

Page 2 of 2

Doc. Type

SOP

Prepared by:

Administrator


Approved by:

Quality Manager

Mohamed Yahia

Effective Date

21.07.2010

Controlled Document

02 Identification of the Management System Documents Quality Manager

SOPs, WIM, standard specifications and other operation reference books are available in the

laboratory for effective execution of testing jobs. Management System documents are uniquely

identified and include Title, Copy No., Date of issue, Revision No., Page No. and issuing

authority. Documents are reviewed after six months and revised if necessary and discussed in

management review meeting.

03 Controlling of Management System Documents Quality Manager

Management System documents generated by the laboratory are controlled by cover page and

inside sections indicating Title, Copy No., Revision No., Issue No., Dates, Section No. and Page

Nos. At the time of initial preparation, the document has issue no 00 revision No. 00. Revision of

document is indicated 01 for first revision and 02 for second revision and so on along with date

C. Document Changes

01 Reviewing the Draft Documents Quality Manager

For bringing improvement in the Management System and working of the laboratory sometimes

changes are required in the documents. Before incorporation these changes in the documents,

these are reviewed by Quality Manager and approved by Director.

02 Amendment in the installed Management System Quality Manager

In case it is felt to incorporate changes or amendments in the management system, it is ensured

that changes do not affect the objective, quality policy and requirements of the accreditation body.

All such changes are immediately informed to the certified body

03 Changes/Revision Control Quality Manager

In case the document is to be revised based upon the feedback/suggestions/comments from the

relevant persons/complaint the inputs are reviewed and changes incorporated by Quality Manager

and forwarded to director for approval. Records of amendments and obsolete documents are

maintained. Documents related to Management System which are maintained in computer have

specific password which are known to the Quality Manager/Director. Periodic changes in

password should be brought into effect to prevent misuse of the information in the computer


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Applicable ISO/IEC 17025:2005 clause : (4. 13) Control of Records

Title:

CONTROL OF RECORDS

Document No.

WM/MR/CR/SOP/01

Copy number: 001

Issue number : 001

Issued to:

All Department

Date: 21.07.2010

Page 1 of 2

Doc. Type

SOP

Prepared by:

Administrator


Approved by:

Quality Manager

Mohamed Yahia

Effective Date

21.07.2010

Controlled Document

1. PurposeTo ensure that the technical and quality records are properly maintained.

2.ScopeCovers all technical and quality records, which demonstrate smooth and effective operations of the Laboratory

as per ISO/IEC 17025 Management System Requirements.

3.References01 WM/MR/CR/WI/01

02 WM/MR/CR/WI/02

03 WM/MR/CR/WI/0304 WM/MR/CR/WI/04

05 WM/MR/CR/WI/05

06 WM/MR/CR/WI/06

07 WM/MR/CR/WI/07

08 WM/MR/CR/WI/08

09 WM/MR/CR/WI/09

10 WM/MR/CR/WI/10

4.Procedure PICA. General

01 Defining the Documentations of Records Quality Manager

Technical records are those which include raw data, analysis protocols, analytical reports, graph

sheets. Whereas the quality records are those records which include reports from Internal Quality

Audits, Management Review Meetings, Calibration Records of Equipments, SOPs, Quality

Manual, Management System Procedures and other records of corrective and preventive action.


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Title:CONTROL OF RECORDS

Document No.WM/MR/CR/SOP/01


Issued to:

All Department

Date: 21.07.2010

Page 2 of 2

Doc. Type

SOP

Prepared by:

Administrator


Approved by:

Quality Manager

Mohamed Yahia

Effective Date

21.07.2010

Controlled Document

02 Records Maintaining Quality Manager

The records are maintained in such a way that the identification (WM/MR/CR/WI/01), collection

(WM/MR/CR/WI/02), indexing (WM/MR/CR/WI/03), access (WM/MR/CR/WI/04), filing

(WM/MR/CR/WI/05), storage (WM/MR/CR/WI/06), maintenance (WM/MR/CR/WI/07), disposal

(WM/MR/CR/WI/08) and retrieval (WM/MR/CR/WI/09) are easy.

03 Records Storing Quality Manager

The records are stored and retained in a manner that they are easily retrievable. The records are

stored in a safe place to prevent damage or deterioration. Retention period of the records is

established. The records are generated in the laboratory to maintain the Management System. All

records are held secure and in confidence. All records are kept under the supervision of Quality

Manager/Technical Manager/Lab In Charge and Commercial In Charge

04 Records Security Quality Manager

The laboratory has implemented appropriate procedures for maintaining security of data including

the prevention of unauthorized access and amendments of computer records by using passwords as

explained detail in WM/MR/CR/WI/10.

B. Technical Records

01 Defining the Documentations of Technical Records Quality ManagerThe laboratory maintains records of original operations, derived calibration records, staff records

and test reports for defined period

02 Analysis Records Analyst

Date of start, observations and date of completion are recorded on the raw data note book by the

analyst. Analysts should make corrections when mistake occurs. Each mistake should be crossed

out but not erase or made illegible or deleted and correct value is entered and initialed.


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Applicable ISO/IEC 17025:2005 clause: (5. 4) Test&Calibration Methods and Method Validation : Control of Data

Title:

CONTROL OF DATA

Document No.

WM/TR/CV/SOP/07

Copy number: 001

Issue number : 001

Issued to:

All Department

Date: 21.07.2010

Page 1 of 3

Doc. Type

SOP

Prepared by:

Administrator


Approved by:

Quality Manager

Mohamed Yahia

Effective Date

21.07.2010

Controlled Document

1.PurposeTo describe how data are recorded, controlled, reviewed, and retained to ensure security, confidentiality, and

loss prevention

2.ScopeCovers all technical and quality data, which demonstrate smooth and effective operations of the Laboratory as

per ISO/IEC 17025 Management System Requirements.

3.References01 WM/TR/CV/WI/07

02 WM/TR/CV/F/07

4.Procedure PICA. Hard Copies

01 Records Classification Quality Manager

Paper hard copies are the primary source document for all WM Accredited Laboratory records.

Classifications of WM Accredited Laboratory records are described below.

Customer records: Document actions taken regarding customer products. All customer records

are confidential and privileged, thus are only available to WM Accredited Laboratory staff.

Personnel records: Document qualifications and performance of WM Accredited Laboratory

staff. Personnel records include signed job descriptions, resumes/qualifications, safety training,

and individual proficiency testing results, continuing education, retraining or counseling

documentation, annual evaluations, and competency checklists. Individual staff members records

are not available to other staff, and are stored in the Supervisors secured files and released to staff

members as needed.

Equipment records: Document equipment performance. Equipment records include

documentation of preventative maintenance, calibration, validation, service and repairs.


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Title:

CONTROL OF DATA

Document No.

WM/TR/CV/SOP/07

Copy number: 001

Issue number : 001

Issued to:

All Department

Date: 21.07.2010

Page 2 of 3

Doc. Type

SOP

Prepared by:

Administrator


Approved by:

Quality Manager

Mohamed Yahia

Effective Date

21.07.2010

Controlled Document

Quality control records: Document activities intended to ensure and verify environmental and

process control. Quality control records include equipment and reagent performance verifications,

supply log sheets, facility environmental monitoring, and external proficiency testing results.

Quality assurance records: Document activities intended to ensure continued and improved

quality through detailed examination, reports, and corrective/preventative action. Quality

assurance records include Nonconforming Product and Events Log and reports, Adverse Reaction

Logs, Validation Protocols, quality assessments, and product log sheets.

02 Records Storage Administrator

All WM Accredited Laboratory records are stored in secured file cabinets in an orderly, readily

retrievable manner. Records may be transferred to WM Accredited Laboratory Record Center for

continued storage or scanned into the computer and stored electronically.

03 Records Identification Administrator

Store the records in folders clearly labeled with their contents. If transferred off-site, an inventory

of each storage box must be maintained in the WM Accredited Laboratory secured file cabinets,

including the WM Accredited Laboratory name and the name of the person preparing the

inventory. Place a copy of this inventory in the front of each box. All WM Accredited Laboratory

records must be retained indefinitely, as required by applicable standards and regulations.

B. Soft Copies

01 Authorization AdministratorOnly WM Accredited Laboratory staff and the Quality Manager have read-write access to create

or modify documents and records in the LAB folder of the WM Accredited Laboratory shared

drive. All other WM Accredited Laboratory staff can access the LAB folder as read-only.


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Title:

CONTROL OF DATA

Document No.

WM/TR/CV/SOP/07

Copy number: 001

Issue number : 001

Issued to:

All Department

Date: 21.07.2010

Page 3 of 3

Doc. Type

SOP

Prepared by:

Administrator


Approved by:

Quality Manager

Mohamed Yahia

Effective Date

21.07.2010

Controlled Document

02 Costumer Data Base AdministratorThe databases of all customers are unique alphanumeric identifiers, and processing data is located

on the WM Accredited Laboratory shared drive in the LAB folder. Separate passwords are

required for routine use (i.e., data entry) and for administrative use (i.e., editing and design). These

passwords are changed quarterly.

03 Back Up AdministratorThe WM Accredited Laboratory shared drive is backed-up nightly by Information Systems staff

according to their SOPs. In addition, the patient database and current SOPs and forms are backed

up monthly onto a USB storage device that is kept in the WM Accredited Laboratory Supervisors

office.

C. Error Correction of Records

01 Handwritten Records AdministratorIf errors are detected, records may be modified using appropriate error correction technique. If the

error is detected on a handwritten record, a single horizontal line is drawn (in indelible black ink)

through the incorrect portion of the record without obscuring the original entry. The correct word

or result is written as close to the error as possible. The person correcting the error must initial and

date next to the error.

02 Computer Generated Records AdministratorIf errors are detected on a computer-generated record that has already been released, reprint the

record, clearly indicating both the originally reported result and the changed result with the

statement Corrected Report. If copies of the record were distributed to other files or

departments, re-distribute a copy of the corrected record.


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EXAMPLE OF CHECK SHEET FOR THE DOCUMENT OR FORMSRELATED TO THE CONTROL OF DOCUMENTATION

Title:

DOCUMENT DISTRIBUTION

LIST

Document No.

WM/MR/DC/F/01-01

Copy number: 001

Issue number : 001

Issued to:

All Department

Date: 21.07.2010

Page 1 of 1

Doc. Type

SOP

Prepared by:

Administrator


Approved by:

Quality Manager

Mohamed Yahia

Effective Date

21.07.2010

Controlled Document

Document Number Name of DocumentList of Document Recipient

1 2 3 4 5 6 7 8*

Note.

1. Master Document2. Director3. Quality Manager4. Technical Manager5. Financial Manager6. Analyst7. Administrator8. Technician


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Title:COPIED DOCUMENT

DISTRIBUTION LIST

Document No.WM/MR/DC/F/01-02


Issued to:

All Department

Date: 21.07.2010

Page 1 of 1

Doc. Type

SOP

Prepared by:

Administrator


Approved by:

Quality Manager

Mohamed Yahia

Effective Date

21.07.2010

Controlled Document

Number of Copy Name Function Department Note


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Title:BORROWING DOCUMENT

HISTORY LIST



Issued to:

All Department

Date: 21.07.2010

Page 1 of 1

Doc. Type

SOP

Prepared by:

Administrator


Approved by:

Quality Manager

Mohamed Yahia

Effective Date

21.07.2010

Controlled Document

No. Name of Document Date Number of Letter Recipient Name Returned Date


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Title:RECEIVING DOCUMENT

PROOF



Issued to:

All Department

Date: 21.07.2010

Page 1 of 1

Doc. Type

SOP

Prepared by:

Administrator


Approved by:

Quality Manager

Mohamed Yahia

Effective Date

21.07.2010

Controlled Document

Received From :

Destination :

Execution Date :

Amount Detail

Received By : Sign :

Execution Date :

Note : Please CC the signed paper to QA department


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Title:RECEIVING DOCUMENT

HISTORY



Issued to:

All Department

Date: 21.07.2010

Page 1 of 1

Doc. Type

SOP

Prepared by:

Administrator


Approved by:

Quality Manager

Mohamed Yahia

Effective Date

21.07.2010

Controlled Document

No Department Publication Date Receiving Date Name Signature


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REFERENCES

EMQAL QM0104 Laboratory Quality Systems: ISO_17025 study materials (power point presentation) by Professor

Ramon Campanyo

EMQAL QM0204 Quality Systems Documentation study materials (power point presentation) by Professor Montse

Llaurado

International Standard: ISO/IEC_17025, 2nd edition, 2005.

P. Konieczka, J. Namienik, Quality Assurance and Quality Control in the Analytical Chemistry Laboratory. A Practical

Approach, CRC Press/Francis and Taylor, Boca Raton, FL, 2009