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BUREAU OF FISHERIES AND AQUATIC RESOURCES

FISH HEALTH MANAGEMENT AND QUALITY ASSURANCE LABORATORY (FHMQAL) Ground Floor, Arcadia Bldg., 860 Quezon Avenue, Quezon City

Document No.

QAM-01 Revision No

1 Effectivity Date

30/01/2012

Introduction

Page No.:

1 of 56

SECTION: 0

Sub-section:

0.1 SUB-TITLE:

Table of Contents

Prepared by:

SGD SONIA S. SOMGA

Quality Assurance Manager

Approved by:

SGD SIMEONA E. REGIDOR

Laboratory Manager

Section

No.

Sub

Section

No. Title Page

0.0

Introduction

0.1 Table of Contents 1 of 3

0.2 Approvals 3 of 3

1.0

General

1.1 Scope and Purpose 1 of 3

1.2 Distribution List and Amendment History 2 of 3

2.0

Overview of the Organization

2.1 FHMQAL Laboratory Profile 1 of 8

2.2 Fig. 1 BFAR Organizational Chart 4 of 8

2.3 Fig. 2 FHMQAL’s Organizational Chart 5 of 8

2.4 Fig. 3 FHMQAL’s Residue Laboratory 6 of 8

2.5 Fig. 4 FHMQAL Business Process 7 of 8

2.6 Quality Policy Statement 8 of 8

3.0

Terms and Definitions

4.0

Management Requirements

4.1 Organization 1 of 7

4.2 Management System 1 of 1

4.3 Control of Documents 1 of 2

4.4 Review of Requests and Contracts 1 of 1

4.5 Subcontracting of Tests and Calibrations 1 of 1

4.6 Purchasing Services and Supplies 1 of 2



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4.7 Service to the Customer 1 of 1

4.8 Complaints 1 of 1

4.9 Control of Nonconforming Testing 1 of 2

4.10 Improvement 1 of 1

4.11 Corrective Action 1 of 2

4.12 Preventive Action 1 of 1

4.13 Control of Records 1 of 1

4.14 Internal Audit 1 of 1

4.15 Management Reviews 1 of 1

5.0

Technical Requirements

5.1 General 1 of 1

5.2 Personnel 1 of 1

5.3 Accommodation and Environmental Conditions 1 of 1

5.4 Test Method Verification 1 of 2

5.5 Equipment 1 of 2

5.6 Measurement Traceability 1 of 1

5.7 Sampling NA

5.8 Handling of Test and Calibration Items 1 of 1

5.9 Assuring the Quality of Test and Calibration Results 1 of 1

5.10 Reporting the Results 1 of 1

6.0

Appendices

6.1 Master List of QMS Procedures 1 of 5

6.2 Master List of Technical Procedures 1 of 5

6.3 Master List of Test Methods 2 of 5

6.4 Master List of Work Instructions 2 of 5

6.5 Master List of Job Descriptions 3 of 5

6.6 Master List of Support Documents 4 of 5



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Introduction

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Approvals

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Laboratory Manager

0.2.1 The FHMQAL QMS complies with all requirements of PNS ISO/IEC 17025:2005 including

government and other relevant rules and regulations relevant to its laboratory service operations.

0.2.2 This document describes how the requirements of PNS ISO/IEC 17025:2005 are being addressed by

the FHMQAL and making reference to the associated QMS documentation. All personnel is required

to receive training in regard to established procedures, work instructions and the quality manual.

0.2.3 The Laboratory Manager of FHMQAS has the overall responsibility for the established QMS.

Management and control of the QMS has been delegation to the FHMQAL QMS.

0.2.4 This manual will be revised and amended as necessary to reflect changes in quality management

system requirements.

BUREAU OF FISHERIES AND AQUATIC RESOURCES FISH HEALTH MANAGEMENT AND

QUALITY ASSURANCE LABORATORY (FHMQAL) Ground Floor, Arcadia Bldg., 860 Quezon Avenue, Quezon City

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GENERAL Page No.:

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Sub-section:

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Scope and Purpose

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Laboratory Manager

1.1.1 SCOPE

1.1.1.1 This Quality Manual describes the Quality Management System (QMS) of the FHMQAL for

its method of conducting business practices. All quality related activities at all levels of

organization are thoroughly discussed and presented in this manual.

1.1.1.2 This Quality Manual outlines the FHMQAL laboratory services and related activities, and as

such covers all actions associated with and having an effect on the outcomes of those

activities.

1.1.1.3 The FHMQAL QMS embodies all processes, materials, skills and professional expertise

required to the provision of testing services that meets the stated needs of its customers.

The quality manual sets out the FHMQAL policy and directions for meeting the requirements

of the International Standard PNS ISO/IEC 17025 (hereafter termed as Standard) and

provides an important documentary guide to the system as a whole.

1.1.2 PURPOSE

1.1.2.1 The FHMQAL established its quality management system to guarantee that the FHMQAL is

technically competent and is able to generate technically valid results. It is aimed to meet

the minimum requirements of the Standard. The basic policies, objectives and guidelines of

the organization related to the various elements of the international standards are also

mentioned and discussed.

1.1.2.2 This Quality Manual has been designed to be a living, working document to all employees of

FHMQAL. This can be used in providing high quality, valuable service to all customers by

covering all the applicable elements of the requirements of the international standards.

1.1.2.3 Details of the QMS processes carried out by all FHMQAL staff are documented separately

in Quality Procedures (QPs), Technical Procedures (TPs), Work Instructions (WIs) and

Support Documents (SDs) which include Test Methods (TMs), Quality Forms (QFs),

References and Standards (REs) including Externally Generated Documents (EXs). The

QPs are referenced within this manual and each QP, WI, TMs, TPs and QF contains

references to the quality documentation, where appropriate.



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1.2.1 Distribution List

1.2.1.1 Distribution list of QMS documents is indicated in Masterlist of QMS documents (SD-QA-

ML01).

1.2.2 Amendment History

Reference No.

Revision

No. Effectivity Date Description

All Sections

0

15/10/2007

Initial issue

All Sections

1

30/01/2012

Revision



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OVERVIEW OF THE ORGANIZATION

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FHMQAL Laboratory Profile

Prepared by:

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SONIA S. SOMGA Quality Assurance Manager

Approved by:

SGD

SIMEONA E. REGIDOR Laboratory Manager

Historical Background

The Fish Health Management and Quality Assurance Section (FHMQAS) which is under the

Bureau of Fisheries and Aquatic Resources started as a Fish Disease Project with funding

from the Canadian government through the International Research and Development Centre

in 1986. It eventually became a section (Fish Health Section) during the 1988 rationalization

under the Aquaculture Division.

When the Philippine Fisheries Code of 1998 was ratified, the Aquaculture Division became the

Inland Fisheries and Aquaculture Division. Because of the involvement of the section in food

safety and quality program of the Bureau through the coordination and implementation of

inspection audit and registration of aquafarms, technical support to quarantine, the Fish Health

Section was placed directly under the control of Director’s Office through the FAO 220, 220-1,

Memorandum Circular No. 1 Series of 2005 and renamed as Fish health Management and

Quality Assurance Section through FOO 181, Series of 2007.

2.1.2 The Bureau of Fisheries and Aquatic Resources

The BFAR is the government agency responsible for the development, improvement, management, and conservation of the country's fisheries and aquatic resources. It was reconstituted as a line bureau by virtue of Republic Act No. 8550 (Philippine Fisheries Code of 1998). The bureau is under the Department of Agriculture (DA).

The FHMQAS operates with the support of the Fish Health Management and Quality Assurance Laboratory to carry out the mandate given by Fisheries Office Order No. 247, Series of 2006.

2.1.3 The Fish Health Management and Quality Assurance Section (FHMQAS)

The FHMQAS of the BFAR is mainly responsible for matters relating to aquatic animal health and residue monitoring and veterinary drug control in fish and fishery products in the Philippines. It operates the Fish Health Management and Quality Assurance Laboratory and provides technical supervision over the Regional Fish Health Laboratories. Specifically, it is mandated to do the following:

2.1.3.1 Assist in the implementation of the national diagnostic and quarantine system for the

movement of living aquatic animals; 2.1.3.2 Formulate guidelines to strengthen the national program on aquatic animal health certification

and quarantine procedures;



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2.1.3.3 Recommend to the Fisheries Regulatory and Quarantine Division (FRQD) policies and

procedures in coordination with the concerned divisions, regulations on aquatic animal health certifications and quarantine procedures;

2.1.3.4 Render emergency diagnostic and technical assistance on fish disease diagnoses and

recommend prevention control and treatment measures; 2.1.3.5 Monitor/assess the health status of stocks in selected fish and other aquatic resource farms in

the Philippines; 2.1.3.6 Provide standards and set directions for different regional fish health satellite laboratories; 2.1.3.7 Serve as a repository of information on fish disease; 2.1.3.8 Establish centralized quarantine facilities for imported live aquatic animals; 2.1.3.9 Develop expertise in the field of fish disease diagnosis, specifically on parasitology,

bacteriology, histopathology, and immunology in support of diagnostic undertakings; 2.1.3.10 Conduct national specialized training programs such as fish health management for

government fishery biologists, extension workers, fish farmers, and other interested individuals;

2.1.3.11 Develop linkages with international and national organizations working on fish health for

information exchange and human resource development purposes; and 2.1.3.12 Represent the Philippine government in international meetings, conferences, seminars,

and workshops on matters pertaining to fish health and live fish quarantine, as directed by management.

2.1.4 The Residue Laboratory

The FHMQAL operates the Residue Laboratory. The Residue Laboratory has been

designated as the National Reference Laboratory (NRL) for residues as per DA Special Order

No. 310, Series of 2005, which states that:

In the interest of service and for continuous delivery of aquatic animal feeds and

drugs quality control services, the Fish Health Laboratory is hereby designated as

the National Reference Laboratory for Veterinary Residues in fish and fishery

Products.



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As National Reference Laboratory, the Fish Health Laboratory shall be

responsible for:

a) coordinating the work of other national laboratories responsible for residue

analysis in fish and fishery products, in particular by coordinating the

standards and methods of analysis for each residues or residue group

concerned;

b) organizing the plan for monitoring residues;

c) periodically organizing comparative tests for each residue or residue group

assigned to them;

d) ensuring that national laboratories observe the limits laid down;

e) Confirmed results for the substance or residue in question if challenged on

the basis of contradictory analysis with the assistance of a third party

laboratory.

2.1.5 Services rendered

A. The Residue Laboratory, under the Fish Health Section, is committed to providing

analytical services for the following pharmaceuticals in fish and fishery products, and

aquatic feeds:

a) Chloramphenicol

b) Furazolidone and its metabolite, AOZ

c) Furaltadone and its metabolite, AMOZ

d) Aflatoxin

B. The laboratory also accepts samples which are subcontracted to other recognized

laboratory.

C. Surveys and Residue Monitoring of fish and aquatic samples from regions nationwide.

D. Technical Assistance.

2.1.6 Stakeholders served

A. Fish Farmers

B. BFAR (Central & Regional Offices)

C. Other Government Sectors

D. Academe

E. Private Sectors



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Fig 1 – BFAR Organizational Chart

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*Section that operates the laboratory

BFAR Director

Administrative Services

Technical Services

Inland Fisheries and Aquaculture Division

Fish Health and

Diagnostic Section*

Administrative Division

Finance Division

Fisheries Post Harvest Technology Division

Fish Inspection Section

Personnel

Property Section

Cashier

Regional Fisheries Office

BFAR Director

Administrative Services

Technical Services

Inland Fisheries and Aquaculture Division

Fish Health and

Diagnostic Section*

Administrative Division

Finance Division

Fisheries Post Harvest Technology Division

Fish Inspection Section

Personnel

Property Section

Cashier

Regional Fisheries Office

Noted by:


15 October 2007

Rev. 0



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Fig 2 – FHMQAS Organizational Chart

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*Unit that will be accredited

Lab Manager

Fish Kill Investigation

Shrimp Health

Finfish Health Molluscan Health

Seaweed Health Veterinary Drugs & Products, Aquatic

Molecular Diagnostic Lab

Residue Lab*

Microbiological Laboratory

Other Non Routine Tests

Administrative Support

Noted by:


15 October 2007

Rev. 0



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Fig 3 – Residue Laboratory Organizational Chart

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Lab Manager

QAM

Administrative

Document and Record

Custodian

Technical Manager

Internal AuditTeam

Lab Analyst

Customer Service

Supply Coordinator

Management Review Team

Purchase Coordinator

EquipmentMaintenance

Team

Review andImprovement

Team

Lab Manager

QAM

Administrative

Document and Record

Custodian

Technical Manager

Internal AuditTeam

Lab Analyst

Customer Service

Supply Coordinator

Management Review Team

Purchase Coordinator

EquipmentMaintenance

Team

Review andImprovement

Team

Approved by:

SIMEONA E. REGIDOR

Laboratory Manager

15 October 2007 Rev. 0



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Quality Policy Statement

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Customer

Laboratory Services Request Handling

Laboratory Analyses

Releasing

( Customer Service)

Customer

Purchasing

( Administrative)

Test Method Validation

Maintenance (Equipment

Maintenance)

Materials Handling and Storage

(Administrative)

Quality Assurance

Human Resource

Financial Management

Management Review

Document and Record Control

Internal Audit

Review and Improvement Team

Customer Satisfaction

Str

ate

gic

Pla

nn

ing

Vision

Mission

Regulation

Policy

Objectives

Supply Control

( Administrative)

Customer

Laboratory Services Request Handling

Laboratory Analyses

Releasing

( Customer Service)

Customer

Purchasing

( Administrative)

Test Method Validation

Maintenance (Equipment

Maintenance)

Materials Handling and Storage

(Administrative)

Quality Assurance

Human Resource

Financial Management

Management Review

Document and Record Control

Internal Audit

Review and Improvement Team

Customer Satisfaction

Str

ate

gic

Pla

nn

ing

Vision

Mission

Regulation

Policy

Objectives

Supply Control

( Administrative)



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Organization and Management

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3.1.1 The following terms are used in the manual and other Quality Management System documentation.

Terms/Acronyms Definition

AMOZ 3-amino-5-morpholino-methyl2-oxazolidinone, a tissue bound

metabolite of furaltadone

AOZ 3-amino-2-oxazolidinone, is a tissue bound metabolite of

furazolidone

AFLATOXIN Carcinogenic, highly toxic metabolites of the mould fungi

Aspergillus flavus and Aspergillus parasiticus

Aquaculture and fishery

products

Harvest from fishery operations involving all forms of raising and

culturing fish and other fishery species in fresh, brackish and

marine waters and other aquatic living resources.

BFAR Bureau of Fisheries and Aquatic Resources, a government agency

responsible for the country’s protection, conservation, improvement

and management of fisheries and aquatic resources

Bias

Also referred to as accuracy or trueness. A measure of the

difference between a measured value to the accepted value.

CAP Chloramphenicol, banned antibiotic for all food producing animals.

Control Chart A graphical method for displaying control results and evaluating

whether a measurement procedure satisfactorily operates within the

pre-determined limits, i.e., in-control or out-of-control. Results are

plotted against time or sequential run number and lines are drawn

from point to point to emphasize trends.

Control Limits Lines drawn on a control chart to provide graphical criteria for

assessing whether measurement procedure is in-control or out-of-

control.

CSO Customer Service Officer



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Customer Fish business operators such as farmers, exporters/importers;

Fisheries regulatory officers such fish inspectors, fish health

officers, quarantine, research institutions, academe and other

concerned stakeholders

DAO Department Administrative Order

DRC Document and Record Custodian

DRO Document and Record Officer

ELISA Enzyme-linked Immunosorbent Assay, enzymatic bioaasay based

on antibody-antigen interaction. This is the method used for

antibiotic residue analysis

Eurachem Reference guide in implementing quality assurance in laboratory

FAO Fisheries Administrative Order

FHMQAS Fish Health Management and Quality Assurance Laboratory, under

the BFAR that provides diagnostics and veterinary drug residues

analysis services

FOO Fisheries Office Order

IQA Internal Quality Audit

ISO Organization for International Standards

Limit of Detection (LOD) The lowest concentration of the analyte that can be conclusively

detected by the method with de defined statistical probability.

Limit of Quantification

(LOQ)

The lowest concentration of analyte that can be accurately

determined quantitatively.

LM Laboratory Manager

Management system Refers to the quality, administrative and technical system that

govern the operations of the laboratory



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MARIS Material Request and Issuance Slip

MSDS Material Safety Data Sheet

NGAS New Government Accounting System

Precision A measure of the closeness between independent test results

under predetermined conditions

Proficiency Test Assessment of performance of the testing method and analysts by

participating in inter-laboratory comparison

QAM Quality Assurance Manager

Reagent blank A solution that contains all the reagents added and which is put

through the entire analytical process but which contains no trace of

the analyte or matrix.

Recovery Rate The recovered concentration of a substance compared to the

expected value, expressed in percentage. A measurement of bias

when no certified reference material is available

Repeatability The precision of the method under conditions where independent

test results are obtained with the same method on the identical

samples, in the same laboratory, with the same analysts and

equipment.

Replicates Test portions of about the same size taken from the same test

sample and carried through the analysis in exactly the same way.

Reproducibility The precision of the method under conditions where independent

test results are obtained with the same method on identical

samples, in different or the same laboratories with different analysts

and equipment

Request for Laboratory

Analysis (RLA)

A form that serves as the contract between the customer and the

laboratory, that the customer agrees on laboratory requirements,

analysis, and other conditions stated



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Residue Chemical retained in animal tissue after metabolic processes

Residue Laboratory Unit at the FHMQAL where antibiotic residue analysis is conducted

RIDASCREEN® Kits used for the analysis of antibiotic residues, a competitive

enzyme immunoassay for the quantitative analysis of antibiotic

residues in shrimp, fish and feeds

Spike A solution of the analyte of known concentration added to the

sample or blank.

Spike Level The theoretical or expected concentration of analyte in a spiked

sample.

Spiked Sample Sample wherein a known concentration of the analyte is added.

Standard Deviation A measure of how spread out the values in a data are set

Subcontracted

Laboratory

Recognized private or government laboratories that conduct

antibiotic residue analysis for FHMQAL

TM Technical Manager

Uncertainty of

Measurement

Parameter associated with the result of measurement that

characterizes the dispersion of the values that could reasonably be

attributed to the measurand.

USP Standards United States Pharmacopeia standards, used in the internal

quality control of the laboratory

Verification The process in which a pre-existing, validated procedure is verified

for its suitability to a specific application and available resources.



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4.1.1 The top management of the Laboratory is ultimately responsible for carrying out its testing

while meeting the requirements of the international standard ISO/IEC 17025:2005 and to

satisfy the needs of the customer, regulatory authorities, or organizations providing

recognition. The organization and management of the FHMQAL is detailed in section 2 of this

quality manual. FHMQAL follows the management structure illustrated in section 2.

4.1.2 The Laboratory has its own permanent facilities and has neither sites away from its

permanent facilities nor temporary /mobile facilities.

4.1.3 The responsibilities and authorities of all personnel who manage, perform, or verify work

affecting the quality of the tests are defined and made known to all employees. The following

provides a summary of the principal responsibilities and authorities of key personnel of

FHMQAL.

a) Laboratory Manager

Responsible for the overall implementation of the QMS;

Formulates Quality Policies and sets the overall directions of the laboratory;

Acts as the overall Technical Manager of the FHMQAS in collaboration with the different

laboratory heads;

Assigns authorities and responsibilities for the implementation of the QMS.

Approves all FHMQAL QMS documentation;

Reviews and approves the Quality Manual, and authorizes its review, addition, revision

and abolition;

Approves the internal quality audit plan;

Makes sure that the necessary resources and personnel are available;

Presides as Chair of the Management Reviews;

Member of the Review and Improvement Team;

Approves objectives, targets and quality improvement programs and allocates resources

required to maintain and ensure the effective and efficient performance of the business

processes;

Approves and signs Test Reports.



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b) Quality Assurance Manager (QAM)

Ensures that the Quality Management System (QMS) of the FHMQAL is established,

implemented, maintained, and approved in accordance with the requirements of ISO/IEC

17025:2005 and its future revisions;

Ensures that the policies set out in this manual are understood, implemented and

maintained at all levels of the organization, and works towards the achievement of the

quality policy, objectives and targets;

Controls the QMS documents;

Handles internal communication, and reports to the Laboratory Manager the performance

of the established QMS, and results of customer feedback;

Ensures that corrective and preventive actions for actual and potential non conformances

are implemented;

Monitors, evaluates and communicates the performance of established QMS to the

employees and top management;

Member of the Management Review Team;

Member of the Review and Improvement Team and responsible for the planning and

conduct of internal audit of QMS;

Conducts awareness and training of all personnel;

Signs and approves test reports in the absence of the Laboratory Manager; and

Performs other duties assigned by the Laboratory Manager.

c) Technical Manager

Prepares procedures covering the technical requirements of the ISO/IEC 17025:2005

standard;

Reviews and approves requested services and supplies in area of responsibility;

Reviews the customer’s requirements and ensures that the laboratory has the capability

and resources to meet the requirements;

Signs the test reports;

Verifies data integrity during recording and transfer of test results;

Validates, evaluates and reviews test methods/test procedures;

Plans, organizes, coordinates and supervises all the activities and equipment of the

assigned laboratory and monitors the effective implementation of the QMS;

Ensures that the QMS is effectively implemented and maintained in area of responsibility;

Ensures that corrective and preventive actions for actual and potential non-conformances

are implemented in the area of responsibility;



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Member of Review and Improvement Team and involved in Management Review Team;

and


d) Document and Record Officer (DRO)

Responsible for document and records management;

Controls the distribution of new or revised documents;

Maintains the template/ format which all documents must follow;

Ensures that all changes in controlled documents are authorized;



are implemented in area of responsibility; and


e) Document and Record Custodian

Assists the Document and Record Officer in the implementation of Document and Data

Control procedure;

Distributes documents and records in accordance with the masterlists and registry of

records determined by the DRO;

Ensures that the set of signatures are complete prior to issuance of controlled documents;

Ensures that all changes in controlled documents are authorized;




Performs other related duties as may be assigned by the Laboratory Manager.

f) Equipment Maintenance Coordinator

Plans, organizes and coordinates the calibration activities of the testing laboratory;

Performs periodic monitoring of the status of test equipment in the laboratory;

Formulates, monitors, reviews and evaluates the calibration methods and procedures;

Facilitates external calibration of laboratory equipment and standard;

Coordinates with the Supply Coordinator and Purchasing Coordinator for the acquisition

of new equipment subject to the evaluation of Laboratory Manager for the

recommendation to the BFAR management;



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are implemented in area of responsibility;


and


g) Pollution Control Officer:

Is familiar with the Pollution Control Laws such as P.D. 1586, P.D. 984, R.A. 6969, R.A.

9003 and the other relevant laws pertaining to Pollution Control;

Prepares, reviews and processes important documents and reports for compliance with

DENR Accreditation for Waste Generator ID permit;

Maintains the safety, proper labeling, and disposal of the existing laboratory chemical

wastes in FHMQAS;

Documents, monitors and manages existing laboratory chemical wastes in FHMQAS;


are implemented in area of responsibility;


and


h) Laboratory Analyst

Conducts laboratory analyses;

Maintains all data and records pertaining to the analysis and related activities;

Performs actions as instructed by Technical Manager;

Develops and documents test methods;

Conducts environmental monitoring of temperature and humidity;

Signs laboratory results.




Performs other duties assigned by the Laboratory Manager

j) Laboratory Aide

Conducts sample preparation for residue analysis;



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Prepares and submits samples to recognized laboratories for subcontracted tests;

Cleans and maintains sample storage area and glasswares used in residue analysis;

Conducts environmental monitoring of temperature and humidity;

Maintains all data and records pertaining to the activities conducted;

Performs actions as instructed by Technical Manager;





k) Administrative Officer

Maintains records of evaluation on the performance of suppliers of critical consumables,

supplies and services which affect the quality of testing and calibration; Maintains the master list of approved suppliers and service providers; Summarizes the customer feedback survey;

Member of the Review and Improvement Team, and Management Review Team;




Performs other related duties as may be assigned by the Laboratory Manager.

.

l) Customer Service Officer

Receives, codes, and distributes samples for laboratory analysis; Entertains walk-in clients, phone inquiries, and customer complaints and refers them to

the staff concerned; Assesses samples and reviews contracts with the clients; Prepares all forms needed for receiving of samples; Prepares job routing slip and brings coded samples to the concerned laboratory for

testing; Prepares and releases laboratory analysis reports and records the date of release; Collects customer feedback surveys and submits them to the Administrative Officer; Ensures that the QMS is effectively implemented and maintained in area of responsibility; Ensures that corrective and preventive actions for actual and potential non-conformances

are implemented in area of responsibility; and Performs other duties assigned by the Laboratory Manager.



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m) Supply Coordinator

Conducts inventory of supplies and materials needed in the laboratory; Ensures that all chemicals/ supplies and materials needed are available on stock all the

time; Maintains master list of chemicals/ supplies and materials with the corresponding

specifications; Checks and receives all deliveries of chemicals/ supplies and materials from Property

Unit; Evaluates performance of suppliers of critical consumables, supplies and services which

affect the quality of testing and calibration; Records/updates masterlist/stock cards for every delivery accepted; Ensures that all supplies are properly labeled; Implements First-In, First-Out system; Ensures that the QMS is effectively implemented and maintained in area of

responsibility; Ensures that corrective and preventive actions for actual and potential non-

conformances are implemented in area of responsibility; and performs other related duties as may be assigned by the Laboratory Manager.

n) Purchase Coordinator

Coordinates the purchase requirements of the Residue Laboratory subject to the

evaluation of Laboratory Manager for recommendation to BFAR management; Prepares Purchase Request as per Material Request Issuance Slip; Process and follow-up purchases of the laboratory; Prepares registry of all subcontractors the laboratory uses for tests and / or calibrations; Ensures that the QMS is effectively implemented and maintained in area of responsibility; Ensures that corrective and preventive actions for actual and potential non-conformances

are implemented in area of responsibility; Performs other related duties as may be assigned by the Laboratory Manager.

o) Internal Auditor

Prepares audit schedule;

Prepares and review audit checklist;

Conducts QMS audit in accordance with the yearly IQA plan;

Records evidence of conformance, non- conformance and observation of audit; and

Prepares QMS audit report for presentation during management review.



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p) Review and Improvement Team

Monitors and keeps track of the implementation of quality objectives, targets and

improvement programs related to area of responsibility;

Participates in setting up of objectives and targets in area of responsibility;

Prepares a report on results of data analysis of all data gathered regarding results of

monitoring, measurement of quality objectives and targets for consolidation, and reports

these during the management review meeting;

Monitors the implementation of corrective and preventive actions taken for any reported

QMS deviations.

Conducts management review of the performance of the QMS with respect to its

suitability, adequacy and effectiveness;

Identifies opportunities for continuous improvement of the FHMQAL based on results of

corrective and preventive actions;

Reviews the quality policy of the objectives bease on relevance and appropriateness; and

Reviews and recommends changes in the policies and procedures as needed;

4.1.4 The Laboratory identifies and provides resources and requirements, including the assignment

of trained and qualified personnel for management, to perform work verification activities, to

identify the occurrence of departures from the quality system, and to initiate actions to

prevent or minimize such departures.

4.1.5 The Laboratory has arrangements to ensure that its management and personnel are free

from any undue internal, external, commercial, financial or other pressures and influences

that may adversely affect the quality of their work.

4.1.6 The Laboratory assigns code numbers for samples, as laid down in QP-AD-01 Review of

Request for Laboratory Analyses to protect customers’ confidentiality and proprietary

rights. The Laboratory has formulated its own house rules to avoid involvement in any

activities that would diminish confidence in its competence, impartiality, judgment or

operational integrity.

4.1.7 To ensure protection of its customer’s confidential information, FHMQAS , has established

the following policies:



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Samples received for testing are uniquely identified through coding. See QP-AD-01

Review of Request for Lab Analyses

Test results/reports shall be transmitted through mail or fax except on cases agreed upon

and approved by the Laboratory Manager. See WI-AD-04, Releasing of Test Reports.

Access to FHMQAS files of Test Reports are controlled such that only FHMQAS Staff can

have the authority to enter as stated in SD-QA-RE06, House Rules.

Visitors and staff are compelled to sign the Statement of Confidentiality, Doc. No. SD-

QA-QF08, prior to entry to the FHMQAS premises.

Access to test witnessing area inside FHMQAS is controlled as stated in the FHMQAS

House Rules, Doc. No. SD-QA-RE06, House Rules

4.1.8 To maintain a high degree of professionalism at the FHMQAS Laboratory, all FHMQAS staff

are expected to abide by the FHMQAS Code of Ethics, SD-QA-RE05.

4.1.9 To control and maintain its competence, standards of performance, and continuity of service,

the FHMQAS has established a special arrangement as shown in Doc No. SD-QA-RE03,

Succession Plan that addresses cases of unavailability of key staff members. The

responsibility is assigned to designated trained staff on a temporary basis until the key person

responsible returns to work.

.



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Management System

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4.2.1 The management system of the FHMQAS Laboratory in line with the requirements of

PNS ISO/IEC 17025:2005 is documented into five (5) levels and is organized as follows:

a) Quality Manual - describes how the requirements of the Standard are being

addressed by the FHMQAS, Residue Laboratory. It provides an overview of the

FHMQAS laboratory business processes. It contains the residue laboratory’s quality

policies, objectives and responsibilities, and makes reference to the associated

documents. This manual may be made available to FHMQAS clients and interested

parties to demonstrate the management's total commitment to quality.

b) Procedure - refers to quality, technical, and administrative procedures that describe

the activities common to all sections of the Laboratory that support the policy

statements in the Quality Assurance Manual.

c) Work Instructions - describes in detail how to accomplish a specific job, task or

assignment, where absence of such may adversely affect the quality of services of the

organization. These include job descriptions of all personnel in all levels of the

laboratory organization, test methods, test procedures, calibration procedures, etc

d) Supporting Documents - documents that define the established key performance

quality parameters, work standards, customers’ requirements, quality plan, quality

objectives, targets and programs.

e) Records – serve as evidence of compliance in the implementation of any and all

quality activities that form part of the established QMS.



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Control of Documents

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4.3.1 POLICY STATEMENTS

4.3.1.1 FHMQAL’s quality management system documents, whether in hardcopy or electronic

form, are uniquely identified. Only authorized copies and current versions are circulated

and used. These include documents generated by the laboratory, and those generated

from external sources such as regulations, standards, test methods, instructions, manuals,

and other relevant references. QP-QA-01, Document Control describes the process for

controlling documents.

4.3.1.2 Master lists of documents are prepared and maintained for both internal (SD-QA-ML01)

and external (SD-AD-ML04) documents. Documents intended for external distribution are

subject to the approval of the Laboratory Manager and marked as “INFORMATION

COPY”. Documents are reviewed once a year during management review for

appropriateness and conformity with the management, technical, or customer

requirements, unless an immediate need for document revision is necessary. All copies of

obsolete documents are removed from all locations to prevent unintended use and are

shredded, except for the original or Master Copy. Obsolete Master Copies are filed in SD-

QA-QR20 and stamped with “OBSOLETE”.

4.3.1.3 New documents and any changes to existing documents proposed by the Process

Owner are reviewed by the Quality Assurance Manager and approved by the

Laboratory Manager. The sections of altered or new text are identified. FHMQAL allows

amendment of documents by hand. Amendments, either by hand or by formal revision,

follow the procedure laid out in Document Control.

4.3.1.4 For electronically stored documents, the amended versions are saved and currently

used and the obsolete versions are deleted from the active files stored on the computer.

Amendments are recorded by the Process Owner in the same manner as other

document types and maintained by the DRC for reference. The computers used to store

documents and records have software installed to protect against hazards such as

malicious and harmful software and to prevent against accidental loss of files.

4.3.2 Responsibilities

4.3.2.1 The Document and Record Custodian (DRC) under the close supervision of the

Document and Record Officer (DRO) is responsible for the management and control of all

documents relevant to each section of the laboratory.



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4.3.2.2 The Master copies of all documents are kept by the (?) Quality Assurance Manager (or in

the document and record storage room?) while the DRC is in charge of the distribution of

controlled copies to authorized holders as detailed in the Distribution List.

4.3.2.3 All documents are maintained by the DRO who ensures that the appropriate documents,

at the correct revision levels, are issued to all who need them within each section of the

laboratory.

4.3.3 References

4.3.3.1 QP-QA-01. Document Control

4.3.3.3 SD-QA-ML01. Master List of QMS Documents

4.3.3.4 SD-QA-QR20. Obsolete Documents (Master Copy)



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Review of Requests and Contracts

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4.4.1.1 The FHMQAS Laboratory carefully reviews and assesses all the requests of customers

for laboratory tests if they are within the laboratory’s capability and requirements. The laboratory

only enters into a contract with a customer when both parties agree on the terms and conditions

set into the contract. The Request for Laboratory Analysis (RLA) serves as the contract between

the laboratory and the customer. The procedure for this is defined in QP-AD-01, Review of

Request for Laboratory Analyses.

4.4.1.2 Samples are assessed by the Customer Service Officer (CSO) following the procedure

WI-AD-01. After assessment, the sample is accepted by filling up the RLA (SD-AD-QF01), and

signed by the customer and the laboratory representative (QP-AD-01). The RLA indicates the

laboratory’s capability, test method, approximate days of testing work, and conditions, in case of

subcontracting the analysis and sample retention.

4.4.1.3 Records of reviews and pertinent discussions with the customer relating to the

customer’s requirements including any significant changes to the request, are documented in the

Job Routing Slip (SD-AD-QFO7) along with the corresponding evaluation of FHMQAL capability.

4.4.1.4 If a request needs to be amended after work has commenced, the same request review

process shall be repeated and any amendments shall be communicated to all concerned

personnel.


4.4.2.1 The Customer Service Officer assesses and reviews the request of the customers for

laboratory test, and processes the contract.

4.4.2.2 The DRC maintains the records of the contract.

4.4.3 References

4.4.3.1 QP-AD-01. Review of Request for Laboratory Analyses

4.5.3.2 WI-AD-01. Sample Assessment



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Subcontracting of Tests and Calibrations

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4.5.1.1 The FHMQAS subcontracts testing and calibration on both a temporary and on a continuing

basis to one of the bureau’s recognized laboratories, preferably to a competent laboratory that complies

with the requirements of PNS ISO/IEC 17025:2005 for the work in question. SD-AD-ML02, Master list

of Approved Suppliers, Service Providers and Subcontractors indicate the names of recognized

laboratories being engaged by the FHMQAL to do the test on its behalf.

4.5.1.2 Subcontracting takes place when the laboratory has positive results in the analysis, as well as

for equipment calibration. The procedure for subcontracting is described in QP-AD-09 (Selection,

Recognition and Evaluation of Supplier and Service Providers).

4.5.1.3 In the event that the work in question is subcontracted, FHMQAL advises the customer of the

arrangement agreed upon prior to acceptance of the Request for Laboratory Analyses, SD-AD-QF01.


4.5.2.1 The Customer Service Officer informs the customer that the test is subcontracted and processes the contract. 4.5.2.2 FHMQAL shall be responsible to the customer for the subcontractor’s work, except in the case where the customer or a regulatory authority specifies which subcontractor is to be used. 4.5.2.3 The Purchase Coordinator shall maintain a register of all subcontractors that it uses for tests and a record of the evidence that the laboratory is PNS ISO/IEC 17025:2005- accredited for the work in question. 4.5.2.4 The Equipment and Maintenance Officer organizes and coordinates external calibrations of equipment.

4.5.3 References

4.5.3.1 TP-RL-05. Equipment Calibration and Maintenance

4.5.3.2 WI-AD-02. Subcontracting of Test

4.5.3.3 SD-AD-ML02. Master list of Approved Suppliers, Service Providers and Subcontractors

4.5.3.4 SD-AD-ML03. Master List of Analyses, Subcontractors, and Fees


QUALITY ASSURANCE LABORATORY (FHMQAL) Ground Floor, Arcadia Bldg., 860 Quezon Avenue, Quezon City.

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Purchasing Services and Supplies

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4.6.1.1 The FHMQAL purchase of equipment, services, laboratory supplies and reagents are

inspected, evaluated and verified for conformance on specifications required before acceptance and

use. The laboratory purchasing procedure (QP-AD-03) follows the government’s regulations and

procedures set in the Manual for the New Government Accounting System (NGAS) for National

Government Agencies.

4.6.1.2 Purchases are made when the critical supplies reach the minimum stock requirement as

indicated in SD-AD-ML01, Master list of Critical Supplies and Consumable Materials. Critical supplies

include among others, the kits, supplies and consumables used in testing which affects the operation

and quality of tests results. Technical specifications for purchases are indicated in the Purchase

Request. The process of requisition is described in QP-AD-03, Purchasing. A master list of suppliers is

maintained and evaluated periodically. Records of evaluations of purchases are filed accordingly.

4.6.1.3 FHMQAL maintains technically approved purchasing documents that contain descriptions of

the essential services and supplies, according to QP-AD-04, Inspection and Receiving of Critical

Supplies and Consumables.

4.6.1.4 The laboratory policy is to evaluate the suppliers of critical consumables, and services which

affect the quality of testing before they are put to use and maintain the suppliers evaluation records and

a list of those approved (SD-AD-ML02, Master list of Approved Suppliers/Service Providers, and

Subcontractors).


4.6.2.1 The Property Section of the BFAR is responsible for ensuring that procurement of materials

and supplies used by FHMQAL is made using only approved suppliers.

4.6.2.2 The Purchase Coordinator takes charge in the preparation, coordination and follow-up of

purchases to the other Administrative Support Units of the bureau. The list of suppliers and records of

evaluation of purchases are maintained.

4.6.2.3 The Administrative Officer maintains a master list of approved suppliers and a record of the

evidence that the names in the master list are evaluated with respect to its performance in accordance

with QP-AD-09 Selection, Recognition and Evaluation of Suppliers /Service Providers


QUALITY ASSURANCE LABORATORY (FHMQAL) Ground Floor, Arcadia Bldg., 860 Quezon Avenue, Quezon City.

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Purchasing Services and Supplies

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4.6.2.4 The Supply Coordinator takes charge in ensuring the technical validity of the purchased

supplies and materials prior to usage.

4.6.2.5 The Supply Coordinator monitors laboratory supplies and initiates request for purchases and

ensures that the laboratory has available stocks of critical supplies at all times.

4.6.3 References

4.6.3.1 QP-AD-03. Purchasing

4.6.3.2 QP-AD-04. Inspection and Receiving of Critical Supplies and Consumables

4.6.3.3 QP-AD-09. Selection, Recognition and Evaluation of Suppliers /Service Providers

4.6.3.4 SD-AD-ML02. Master list of Approved Suppliers/Service Providers, and Subcontractors



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Service to the Customer

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4.7.1 Policy Statement

4.7.1.1 The FHMQAL informs the customer or any interested party about the laboratory’s testing

services, policies and requirements. The laboratory may provide its customers various types of

cooperations such as:

4.7.1.2 Reasonable but controlled access to relevant areas of the FHMQAS for the witnessing of

tests performed as approved by the Laboratory Manager.

4.7.1.3 Communicate particularly regarding information of any delays or major deviations in the

performance of the tests.

4.7.1.4 Obtain customer feedback for the improvement of the FHMQAL’ QMS, its testing activities and

service following QP-AD-02 Customer Satisfaction Survey. Records of comments are maintained and

taken up during the Management Review.

4.7.1.5 The laboratory provides technical assistance to customer inquiries regarding laboratory results

and their interpretation, and other concerns within the bounds of the contract.

4.7.1.6 As the laboratory allows the witnessing of testing activity, confidentiality is maintained by

designating a place outside the testing area for witnessing. All visitors must sign a SD-QA-QF08

(Confidentiality Statement) before they are permitted through.


4.7.2.1 The Customer Service Officer (CSO) directly deals with the customer and is responsible for

informing customers in cases of unexpected deviations from the contract.

4.7.2.2 The Customer Service Officer is responsible for ensuring that service to customers is

maintained in order to ensure a long lasting relationship

4.7.2.3 Any FHMQAS staff is encouraged to obtain feedback from its customers, both positive and

negative.

Customer Feedback Records are maintained by the DRO/DRC.

4.7.2.4 The Quality Assurance Manager ensures that this policy is implemented and make sure that

feedback from customers are evaluated and used for improvement of the quality management system.



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4.7.3 References

4.7.3.1 QP-AD-02. Customer Satisfaction Survey

4.7.3.2 SD-QA-QF08 Confidentiality Statement



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Complaints

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4.8.1.1 The FHMQAL takes care and resolves all complaints whether written, verbal or through

telephone, received from customer or any party. Complaints are recorded and evaluated following QP-

AD-08, Handling of Complaints. Appropriate corrective and preventive actions are implemented using

QP-QA-05.

4.8.1.2 All complaints received are immediately evaluated by the Review and Improvement Team and

corrective and preventive actions are taken when necessary.

4.8.1.3 Records of all complaints received, investigations, and corrective action are maintained.

These are discussed during the management review.

4.8.1.4 Internal audits (QP-QA-06) may be conducted apart from the scheduled audit when

complaints raise doubts about the Laboratory’s compliance with its own policies and procedures.


4.8.2.1 Any FHMQAL personnel can receive complaints. Investigation, internal audit and corrective

actions are conducted by designated staff as stated in the procedure for Handling of Complaints.

4.8.2.2 The QAM in coordination with the Customer Service Officer is responsible for handling and

resolving complaints received from customers and other interested parties

4.8.2.3 The Review and Improvement Team conducts evaluation and investigation of complaints and

recommends appropriate corrective and preventive actions.

4.8.2.4 Records of investigations and corrective actions are maintained by the DRC.

4.8.3 References

4.8.3.1 QP-AD-08 Handling of Complaints

4.8.3.2 QP-QA-05 Corrective and Preventive Action

4.8.3.3 QP-QA-06 Internal Audit

1 BUREAU OF FISHERIES AND AQUATIC RESOURCES FISH HEALTH MANAGEMENT AND


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4.9 SUB-TITLE:

Control of Non Conforming Work

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SGD



4.9.1.1 FHMQAL implements QP-QA-03, Control of Non-Conforming Work (as defined in QP-QA-

03, Control of Non-Conforming Work) when tests do not conform to certain criteria or the

agreed requirements of the customer, and ensures that

a) actions are taken when non-conforming work is identified;

b) evaluation of the significance of the non-conforming work is made;

c) where necessary, the customer is notified and work is recalled or repeated.

4.9.1.2 Any non-conformance identified are documented then evaluated and corrected immediately

following QP-QA-05, Corrective and Preventive Actions.

4.9.1.3 Non-conforming testing are investigated and evaluated by the Technical Manager.

Corrective actions are implemented as soon as the non-conforming test is confirmed. If non-

conformance necessitates tentative suspension of testing and withholding of test reports,

the customers that have on-going contracts are notified immediately. In case results have

already been issued, the customer is notified and the results are recalled. Resumption of

work is decided by the Laboratory Manager once the corrective and preventive actions have

been undertaken. Records of non-conformities are maintained and used as basis for

improvement during management review.

4.9.1.4 Non conformances may also arise during the control of samples and customer-supplied

products.


4.9.2.1 The Laboratory Manager designates the Review and Improvement Team (RIT), to investigate

and take the necessary appropriate action when non-conforming work is identified.

4.9.2.2 The Laboratory Manager, in coordination with the Quality Assurance Manager and/or the

Technical Manager, is responsible for the appropriate disposition of nonconforming work. The

disposition decision can be any of the following:

a) Retest

b) Re-sampling

c) Scrapping / regarded for alternative application for chemical materials

d) Adjustment, calibration, maintenance of equipment

1 BUREAU OF FISHERIES AND AQUATIC RESOURCES FISH HEALTH MANAGEMENT AND


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Control of Non Conforming Work

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4.9.2.3 Records of non-conformities, evaluation and corrective actions taken are maintained by the

DRC.

4.9.2.4 The Customer Service Officer (CSO) notifies the customer of the non conforming testing and

informs them of their sample’s status.

4.9.3 References

4.9.3.1 QP-QA-03. Control of Non-Conforming Work

4.9.3.2 QP-QA-05 Corrective and Preventive Actions



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4.10 SUB-TITLE:

Improvement

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SGD



4.10.1.1 The FHMQAL continuously improves the suitability and effectiveness of its Quality

Management System through constant monitoring and evaluation of the policies, objectives,

audit results, data, corrective and preventive actions and the results of management review.

4.10.1.2 Quality objectives are established in all relevant functions of the laboratory to support and

implement the quality policy, to meet requirements for services and processes, and to

improve the QMS and performance. Quality Objectives and Targets, define the FHMQAL’s

direction and priorities for which are reviewed and evaluated at least once a year.

4.10.1.3 The review is undertaken on a regular basis and records of discussions during the

management review process are documented. Possible opportunities for improvements in

the existing QMS are decided by the management and implemented by the personnel

where areas of activities affected.


4.10.2.1 The MRT is responsible for conducting and recording the management review at least once

a year.

4.10.2.2 The Heads of the different functions are responsible for the implementation of corrective and

preventive actions for continual improvement.

4.10.2.3 Any personnel can identify and propose the necessary improvements to the management

team.

4.10.2.4 The Quality Assurance Manager ensures that improvements are implemented

4.10.3 References

4.10.3.1 QP-QA-03 Control of Non-Conforming Work



4.10.3.4 QP-AD-02 Customer Satisfaction Survey


4.10.3.6 QAM 01-2.6 Quality Policy Statement



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4.11 SUB-TITLE:

Corrective Action

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SGD



4.11.1.1 The FHMQAL formulates and implements QP-QA-05, Corrective and Preventive Actions,

when any non-conformances or deviations from the policies and procedures have been

identified. The procedure starts with a thorough investigation of the problem to identify the

possible root cause of the non-conformance.

4.11.1.2 Corrective actions are identified as necessary during any of the following situations:

a) Non-conformities arise

b) Internal or external audits

c) Complaints and feedback are received

d) Management reviews

4.11.1.3 Corrective actions are approved by the Laboratory Manager and implemented by the

designated personnel responsible in the area where non-conformance occurred.

4.1.1.2 When the non-conformances or deviations cast doubts on the Residue laboratory’s

compliance with its own policies and procedures, FHMQAL shall ensure that the concerned

areas of activity are audited in accordance with QP-QA-06, Internal Audit, as soon as

possible.


4.11.2.1 The Management Review and Improvement Team identify and select potential corrective

actions to address non-conformities to prevent recurrence.

4.11.2.2 The designated personnel in the area where non-conformance occurred is responsible for

the implementation of the corresponding corrective actions.

4.11.2.3 The Quality Assurance Manager, in collaboration with the concerned section and/or

personnel, is responsible for ensuring that corrective and preventive actions are

implemented in a timely manner.

4.11.2.4 The Quality Assurance Manager facilitates the review process of non-conformities identified.

4.11.2.5 The DRC maintains records of corrective actions and related documents.



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Corrective Action

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4.11.3 References


4.11.3.2 QP-QA-03 Control of Non-conforming Work



4.11.3.5 QP-AD-02 Customer Satisfaction Survey



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4.12 SUB-TITLE:

Preventive Actions

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SGD



4.12.1.1 The FHMQAL develops and implements preventive actions when potential sources of non-

conformities on the management system and technical operations are identified, to reduce

the risk of occurrence. The procedure, QP-QA-05 (Corrective and Preventive Actions)

explains the initiation and application of preventive actions.

4.1.1.3 Preventive action is initiated by the Process Owner where opportunities for improvement

are found upon review of the operational procedures and analysis of data. Preventive

actions are approved by the Laboratory Manager before application. Any preventive

actions are monitored for effectiveness and suitability. These are evaluated during the

management review.


4.12.2.1 Process Owner proposes preventive actions on areas of work where potential sources of

non-conformities are identified.

4.12.2.2 The Quality Assurance Manager takes charge of preventive actions in the management

system procedures

4.12.2.3 The Technical Manager takes charge of preventive actions concerning technical

operations.

4.12.3 References

4.12.3.1 QP-QA-05. Corrective and Preventive Actions



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4.13 SUB-TITLE:

Control of Records

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SGD



4.13.1.1 The FHMQAL quality management system records whether in hard copy or electronic

form are controlled, stored properly and secured to prevent damage/ loss, and only

authorized personnel have access. The procedure for controlling records (QP-QA-02)

describes the process of filing, maintaining, retrieving and disposing of quality and

technical records.

4.1.1.4 All quality and technical records are filed and stored at the designated record file cabinet.

The records are retained for three years prior to storage in a separate archival facility for

two more years, after which they shall be appropriately disposed of. Quality records

include reports from audits, management reviews and corrective and preventive actions.

Technical records include the laboratory results, original data obtained in testing process

and information related to traceability of samples. Amendments to records may be done

in full or in part, formally or by hand, following QP-QA-08, Amendments to Records and

Reports.

4.1.1.5 Electronically stored records have back-up files and are protected from loss due to virus or

hazards.


4.13.2.1 The Document and Record Custodian (DRC) under the close supervision of the Document

and Record Officer (DRO) is responsible in the management, control and disposal of all

records.

4.13.2.2 All records are available with the Quality Assurance Manager for retrieval.

4.13.3 References

4.13.3.1 QP-QA-02 Control of Data and Records

4.13.3.2 QP-QA-08 Amendments to Records and Reports



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4.14 SUB-TITLE:

Internal Audit

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SGD


Approved by:

SGD



4.14.1.1 The FHMQAL conducts an internal audit of the laboratory operation and testing activities

once a year to verify conformance with the management system. Internal audits are also conducted

when necessary, in the case of a complaint on the reliability of test results, or a non-conformance in

testing is detected.

4.14.1.2 An internal audit is organized and carried out by a team composed of personnel independent

of the activities being audited. When audit results cast doubt upon the effectiveness of the operations

or on the accuracy or reliability of the laboratory’s test, the corresponding actions are implemented

following QP-QA-05, Corrective and Preventive Actions. Follow-up audits are conducted to verify the

implementation and effectiveness of the actions. Whenever necessary, the customer will be notified if

laboratory results have been affected. Records of audits, findings and corrective actions are

maintained and are discussed during the management review.


4.14.2.1 The Quality Assurance Manager is responsible for planning, organizing and scheduling of

audits, and notifies the personnel in the area of activities that will be audited.

4.14.2.2 The DRC maintains the records of audit activities.

4.14.3 References





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4.15 SUB-TITLE:

Management Review

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SGD



4.15.1.1 The FHMQAL conducts an internal audit of the laboratory operation and testing activities

once a year to verify conformance with the management system. Internal audits are also

conducted when necessary, in the case of a complaint on the reliability of test results, or a

non-conformance in testing is detected.

4.1.1.6 An internal audit is organized and carried out by a team composed of personnel

independent of the activities being audited. When audit results cast doubt upon the

effectiveness of the operations or on the accuracy or reliability of the laboratory’s test, the

corresponding actions are implemented following QP-QA-05, Corrective and Preventive

Actions. Follow-up audits are conducted to verify the implementation and effectiveness of

the actions. Whenever necessary, the customer will be notified if laboratory results have

been affected. Records of audits, findings and corrective actions are maintained and are

discussed during the management review.


4.15.2.1 The Quality Assurance Manager is responsible for planning, organizing and scheduling of

audits, and notifies the personnel in the area of activities that will be audited.

4.15.2.2 The DRC maintains the records of audit activities.

4.15.3 References





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Management Review

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POLICY STATEMENTS

4.15.3.3 The FHMQAL administers a management review of the laboratory’s management system,

operation and testing activities once a year to ensure continuously suitable and effective

services and to introduce changes or improvements in the management system.

4.1.1.7 The management review is led by the Laboratory Manager. It is a yearly assessment of

the policies and procedures, findings of audits conducted and corrective actions,

complaints, results of tests, results of customer feedback, trainings and other concerns of

the staff. The records of the result of the management review are maintained and are

included in planning the activities of the laboratory for the following year to improve the

system.


4.15.4.1 The Laboratory Manager determines the schedule and leads the management review

process.

4.15.4.2 The Quality Assurance Manager consolidates the result of the management review.

4.15.4.3 The DRO/DRC maintains the records on the result of management activities.

4.15.5 References

4.15.5.1 SD-QA-QF03 Notice of Meeting

4.15.5.2 SD-QA-QF04 Attendance Sheet

4.15.5.3 SD-QA-QF11 Minutes of Meeting



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Sub-section:

5.1 SUB-TITLE:

General

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SGD



5.1.1.1 The FHMQAL identifies all factors that contribute to the reliability of test results and these are

considered in the development and validation of test method, in training and qualifying of

personnel, and selection and calibration of equipment, sampling and handling of test item

and accommodation and environmental conditions.


5.1.2.1 The Laboratory Manager approves all policies and procedures for ensuring correct and

reliable test result.

5.1.2.2 The Quality Assurance Manager ensures that all policies and procedures are implemented

and followed.

5.1.2.3 The Technical Manager takes charge on the technical operations of the laboratory.



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Personnel

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SGD



5.2.1.1 The FHMQAL ensures that all personnel performing specific tasks such as operating

equipment, performing tests, evaluating results and signing the test reports are competent

and are qualified based on education, training and experience. Newly-hired personnel

undergo the appropriate training, as decided through an analysis of the training needs of a

function or position and work under supervision until they are found sufficiently skilled.

5.2.1.2 The laboratory maintains current job descriptions for managerial, technical and key support

personnel. The management authorizes certain personnel to perform particular tasks such as

sampling, testing, issuing of test reports, giving opinions and interpretations, and operating

particular equipment.

5.2.1.3 The management system provides training program for personnel. Training needs relevant to

their tasks are identified by the Laboratory Manager and the effectiveness of these trainings is

evaluated during the management review. Records of authorization, competence, educational

and professional qualifications, training, skills and experience of all technical personnel

including contracted personnel are maintained and are readily available.


5.2.2.1 The Laboratory Manager determines qualifications of laboratory personnel

5.2.2.2 The Quality Assurance Manager ensures that personnel are qualified to perform their

assigned tasks.

5.2.2.3 The DRC maintains the records of all personnel.

5.2.3 References

5.2.3.1 QP-QA-04 Training Needs

5.2.3.2 WI-JD-01 to 15 Job Descriptions



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5.3 SUB-TITLE:

Accomodation and Environmental Conditions

Prepared by:

SGD SONIA S. SOMGA


Approved by:


Laboratory Manager


5.3.1.1 The FHMQAL monitors environmental conditions such as temperature, humidity and

vibrations in facilities of testing that may influence the quality of any measurements.

5.3.1.2 The laboratory identifies environmental conditions required by methods and procedures, and

quality test results. These include temperature, humidity, vibrations, dust, contaminants,

etc. The facilities for testing is separated from other tests conducted in the laboratory to

prevent cross contamination, and only authorized personnel have access and can use the

areas for testing. General housekeeping and maintenance procedures are being

implemented by personnel in the laboratory. Records of monitoring are maintained and

being reviewed by the Technical Manager regularly


5.3.2.1 The Technical Manager oversees the monitoring of accommodations and environmental

conditions in the testing facility

5.3.2.2 The Analyst monitors the environmental conditions relevant to their activities.

5.3.3 References

5.3.3.1 WI-RL-09 Monitoring Accommodation and Environmental Conditions

5.3.3.2 SD-QA-RE06 House Rules



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5.4 SUB-TITLE:

Test Method Verification

Prepared by:

SGD SONIA S. SOMGA


Approved by:


Laboratory Manager


5.4.1.1 The FHMQAL uses appropriate and validated methods and procedures for testing residues in

fish and fishery products within its scope. These include sampling, handling, storage, and

preparation of items for testing and, where appropriate, estimation of the measurement uncertainty

for analysis of test.

5.4.1.2 Procedures for the development, modification and selection of methods and method

verification are established.

5.4.1.3 The laboratory uses non-standard method for residues with modifications. They are validated

by the method developers and verified by the FHMQAL to ensure its fitness for the intended

purpose. The results of verification are recorded. Verification is carried out prior to the

method’s first use and when major changes in the method are adopted.

5.4.1.4 The method’s performance is evaluated through the use of reference standards, control charts

and scheduled inter-laboratory comparisons.

5.4.1.5 The laboratory identifies all the components of uncertainty and makes a reasonable

estimation of uncertainty of measurement.

5.4.1.6 The laboratory has instructions for all relevant methods and procedures from handling and

preparation of items for testing and use of equipment. Deviations are documented,

technically justified, authorized and accepted by the customer.

5.4.1.7 The laboratory uses computer software for generating testing results. Data are stored and

protected for its integrity and confidentiality, as in the control of records. All instructions,

standards, manuals and reference data relevant to the work of the laboratory are kept up

to date and are readily available to personnel.


5.4.2.3 The Technical Manager takes charge of the technical operations of the laboratory such as test

method selection, verification, estimation of measurement of uncertainty.

5.4.2.4 The analyst is responsible for carrying out verification activities according to the plan and

reporting the results to the Technical Manager.



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Test Method Verification

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Laboratory Manager

5.4.3 References

5.4.3.3 TP-RL-01 Estimation of Measurement Uncertainty

5.4.3.4 TP-RL-02 Development, Modification and Selection of Test Methods

5.4.3.5 TP-RL-03 Test Method Verification



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Sub-section:

5.5 SUB-TITLE:

Equipment

Prepared by:

SGD SONIA S. SOMGA


Approved by:


Laboratory Manager


5.5.1.1 The FHMQAL equipment is checked for the specified standard specification requirement and

is calibrated before use. All equipment which have significant effect on the results are

calibrated yearly.

5.5.1.2 All equipment are operated by authorized personnel. Up-to-date instructions on the use and

maintenance of each equipment is readily available for use by laboratory personnel. Each

equipment is uniquely identified.

5.5.1.3 Records are maintained for each equipment and its software significant to the test performed.

Records include the identity, location, condition, status of calibration, etc.

5.5.1.4 Procedure for safe handling, use and planned maintenance of equipment is followed to

ensure proper functioning of equipment. All equipment requiring calibration are labeled

indicating the status of calibration, date when last calibrated and when the next calibration

is. Intermediate checks on some equipment are done to maintain confidence in the

calibration status of equipment. Where calibrations give rise to a set of correction factors,

the laboratory has a procedure to ensure that copies are correctly updated.

5.5.1.5 Equipment that are mishandled, defective or outside the specified limits are isolated, labeled

as out of service until repair is done and perform correctly.

5.5.1.6 All equipment that needs to be taken out of the laboratory either for calibration or repair are

controlled. The laboratory examines the effect of the defect or departure from specified

limits on previous tests and institutes the control of non conforming work procedure.

5.5.1.7 The Equipment Maintenance Officer gives notice to the laboratory two weeks before a piece

of equipment is scheduled for maintenance or calibration. The users may submit their

request for a delay in the temporary removal of the equipment and the Laboratory

Manager decides if the request may be approved or denied.


5.5.2.1 The Equipment Calibration and Maintenance Coordinator takes charge of preventive

maintenance of equipment in the laboratory.



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Equipment

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Approved by:


Laboratory Manager

5.5.2.2 The Equipment Calibration and Maintenance Coordinator takes charge of monitoring the

status of the equipment in the laboratory.

5.5.2.3 The Process Owner reports to Equipment Calibration and Maintenance Coordinator any

defects in the performance of the equipment.

5.5.3 References

5.5.3.1 QP-AD-03 Purchasing

5.5.3.2 TP-RL-05 Equipment Calibration and Maintenance



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5.6 SUB-TITLE:

Measurement Traceability

Prepared by:

SGD SONIA S. SOMGA


Approved by:


Laboratory Manager


5.6.1.1 The FHMQAL ensures that all equipment for testing that affect the accuracy of the test result

are calibrated before use. The laboratory follows the procedure for selecting, using,

calibrating, checking controlling and maintaining equipment used to perform test.

5.6.1.2 Equipment are calibrated externally once a year in a government metrological institute or its

accredited calibration service provider. The calibration measurements are traceable to SI

units of measurements. Calibration certificates issued contain the measurement results,

including measurement of uncertainty and a statement of compliance with an identified

metrological specification. Intermediate checks are conducted on equipment if the

laboratory has capability.


5.6.2.1 The Equipment Calibration and Maintenance Coordinator takes charge of equipment

calibration.

5.6.2.2 The Process Owner conducts intermediate checks.

5.6.3 Reference

5.6.3.1 TP-RL-05 Equipment Calibration and Maintenance



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Sub-section:

5.8 SUB-TITLE:

Handling of Test and Calibration Items

Prepared by:

SGD SONIA S. SOMGA


Approved by:

SIMEONA E. REGIDOR

Laboratory Manager


5.8.1.1 FHMQAL provides a system of handling of the test item to protect its integrity, and the interest

of the laboratory and the customer. Handling of test items includes the transportation, receipt,

handling, storage, retention and disposal.

5.8.1.2 The laboratory assigns identification to all test items received and this identification is retained

with the item throughout the testing process. This will ensure that items are traceable. It includes

laboratory sampling, and the transfer of items for analysis or calibration within and from the

laboratory. Handling instructions provided with the items are followed to avoid deterioration, loss and

damage to the test item during storage, handling and preparation. Test items stored are maintained,

monitored and recorded. When the item does not conform with the requirement for the test, or there

is doubt on its suitability for the analysis, the item may be rejected depending on the non-

conformance and the customer is informed of the requirements.


5.8.2.1 The Analyst implements the laboratory sampling plan and procedures and maintains all the

records.

5.8.2.2 The Customer Service Officer ensures that procedures from sample reception up to the

delivery to the laboratory are followed and maintains all the records.

5.8.2.3 The Technical Manager monitors and makes sure that procedures are implemented and

followed properly.

5.8.3 References

5.8.3.1 QP-QA-07 Handling and Transport of Samples for Laboratory Analyses

5.8.3.2 QP-AD-10 Handling and Delivery of Samples to Subcontractors

5.8.3.3 WI-RL-02 Sample Storage and Disposal

5.8.3.4 WI-AD-01 Sample Assessment



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5.9 SUB-TITLE:

Assuring the Quality of Test and Calibration Items

Prepared by:

SGD SONIA S. SOMGA


Approved by:

SIMEONA E. REGIDOR

Laboratory Manager


5.9.1.1 FHMQAL implements quality control for monitoring validity of tests performed. The

resulting data records and the trends are evaluated, and where practicable, statistical techniques

are applied in reviewing the results.

5.9.1.2 As internal quality control, the laboratory uses secondary reference materials such as USP

standards, participates in inter-laboratory comparison, and replicates tests. If a test result is found

outside pre-defined criteria, it is not reported. Instead, evaluated and corrective actions taken when

necessary. Data obtained are maintained and included in the management review.


5.9.2.1 The Analyst implements the sampling plan and procedures and maintains all the records.

5.9.2.2 The Technical Manager ensures that the procedures are implemented and followed properly

and monitors quality control in the testing process.

5.9.3 References

5.9.3.1 TP-RL-04 Quality Control Procedures

5.9.3.2 TP-RL-03 Test Method Verification

5.9.3.2 QP-QA-03 Control of Non-conforming Work



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5.10 SUB-TITLE:

Reporting the Results

Prepared by:

SGD SONIA S. SOMGA


Approved by:


Laboratory Manager


5.10.1.1 The format of report is standardized. It accommodates each type of test carried out

and is presented for easy understanding by the customer or reader. Each test report

includes the :

a) title,

b) name and address of the laboratory,

c) unique identification of the sample,

d) pagination,

e) name and address of customer,

f) method used,

g) the date of receipt of sample and the dates of performance of the test, and

h) the name, function and signature of the person authorizing the test report.

i) Other information are readily available in the laboratory, upon request of customer.

5.10.1.1.1 For subcontracted tests, the report of results are clearly identified and reported in writing.

5.10.1.2 Test reports are not allowed to be reproduced except in full, without written approval of

the Laboratory Manager. The laboratory provides interpretation of the results by direct

dialogue with the customers, when necessary.

5.10.1.3 When an amendment to test report is necessary after it has been released, the

original/incorrect document must be recalled and surrendered, and the procedure for

amending test reports followed.


5.10.2.1 The Laboratory Manager reviews and approves the test report

5.10.2.2 The Technical Manager reviews results and signs the report.

5.10.2.3 The Customer Service Officer releases test results to customers.

5.10.3 References

5.10.3.1 QP-AD-07 Reporting the Results

5.10.3.2 QP-QA-08 Amendments to Records and Reports