Third-Party Laboratory Data Quality Management

Download as pdf or txt
Download as pdf or txt
You are on page 1of 12

PETRONAS TECHNICAL STANDARDS

Third-party Laboratory Data Quality Management

PTS 16.63.01
March 2017

Internal
© 2017 PETROLIAM NASIONAL BERHAD (PETRONAS)
All rights reserved. No part of this document may be reproduced, stored in a retrieval system or transmitted in any form
or by any means (electronic, mechanical, photocopying, recording or otherwise) without the permission of the copyright
owner. PETRONAS Technical Standards are Company’s internal standards and meant for authorized users only.
PTS 16.63.01
THIRD-PARTY LABORATORY DATA QUALITY MANAGEMENT March 2017
Page 2 of 12

FOREWORD

PETRONAS Technical Standards (PTS) have been developed based on the accumulated knowledge,
experience and best practices of the PETRONAS group supplementing National and International
standards where appropriate. The key objective of PTS is to ensure standard technical practice across
the PETRONAS group.

Compliance to PTS is compulsory for PETRONAS-operated facilities and Joint Ventures (JVs) where
PETRONAS has more than fifty percent (50%) shareholding and/or operational control, and includes
all phases of work activities.

Contractors/manufacturers/suppliers who use PTS are solely responsible in ensuring the quality of
work, goods and services meet the required design and engineering standards. In the case where
specific requirements are not covered in the PTS, it is the responsibility of the
contractors/manufacturers/suppliers to propose other proven or internationally established
standards or practices of the same level of quality and integrity as reflected in the PTS.

In issuing and making the PTS available, PETRONAS is not making any warranty on the accuracy or
completeness of the information contained in PTS. The contractors/manufacturers/suppliers shall
ensure accuracy and completeness of the PTS used for the intended design and engineering
requirement and shall inform the Owner for any conflicting requirement with other international
codes and technical standards before start of any work.

PETRONAS is the sole copyright holder of PTS. No part of this document may be reproduced, stored
in a retrieval system or transmitted in any form or by any means (electronic, mechanical, recording or
otherwise) or be disclosed by users to any company or person whomsoever, without the prior written
consent of PETRONAS.

The PTS shall be used exclusively for the authorised purpose. The users shall arrange for PTS to be
kept in safe custody and shall ensure its secrecy is maintained and provide satisfactory information to
PETRONAS that this requirement is met.

Internal
PTS 16.63.01
THIRD-PARTY LABORATORY DATA QUALITY MANAGEMENT March 2017
Page 3 of 12

ANNOUNCEMENT

As part of the recent transformation exercise, the PTS numbering system has been revised to 6-digit
numbers and drawings, forms and requisition to 7-digit numbers. All newly revised PTS will adopt this
new numbering system, and where required make reference to other PTS in its revised numbering to
ensure consistency. Users are requested to refer to PTS 00.01.01 (PTS Index) for mapping between
old and revised PTS numbers for clarity. For further inquiries, contact PTS administrator at
ptshelpdesk@petronas.com.my

Internal
PTS 16.63.01
THIRD-PARTY LABORATORY DATA QUALITY MANAGEMENT March 2017
Page 4 of 12

Table of Contents
1.0 INTRODUCTION ..................................................................................................... 5
1.1 SCOPE .............................................................................................................................. 6
1.2 GLOSSARY OF TERMs ...................................................................................................... 6
1.3 SUMMARY OF CHANGES ................................................................................................. 7
2.0 DATA MANAGEMENT PROCESS.............................................................................. 8
3.0 BIBLIOGRAPHY .................................................................................................... 11

Internal
PTS 16.63.01
THIRD-PARTY LABORATORY DATA QUALITY MANAGEMENT March 2017
Page 5 of 12

1.0 INTRODUCTION

This PTS establishes a simplified process to ensure that all sampling and analysis data
generated by third-party laboratories (TPLs) commissioned by a PETRONAS Holding Company
Unit, Business Unit, Operational Unit, Joint Venture and Project (HCU/BU/OPU/JV/Project),
meet acceptable standards of traceability and quality.

Sampling and analysis of chemicals, environmental samples and any other matrices amenable
for laboratory-related processes carried out as part of due diligence, compliance and/or
production requirements are regularly outsourced across PETRONAS
HCU/BU/OPU/JV/Projects. Examples of the use of laboratory test results include, but are not
limited to:

I. Regulatory compliance against quality criteria for discharged effluents/emissions

II. Product stewardship purposes, specifically in the hazard classification of


PETRONAS products

III. Monitoring worker health

IV. Incident investigations

The process for data management for TPLs laid out in this PTS is expected to address
transparency and quality assurance issues, by impacting on the sampling and analysis aspects
of the following focus areas and their requirements within the Health, Safety & Environment
Mandatory Control Framework:

I. Health
a) Health risk assessment
b) Chemical management
c) Substance misuse
d) Food and water safety (related to incident investigation)

II. Environment
a) Air emission management
b) Hazardous waste management
c) Soil and groundwater management
d) Wastewater management

III. Contractor HSE management

IV. Incident Management & Emergency Response


a) Incident investigation and reporting

Due to the value of generated analytical data as well as other associated documentation such
as quality reports and traceability forms i.e. chain of custody (CoC), which is the sole property
of PETRONAS, it is necessary to establish a transparent process aiming to ensure the validity,
integrity and reliability of TPL analytical data.

Internal
PTS 16.63.01
THIRD-PARTY LABORATORY DATA QUALITY MANAGEMENT March 2017
Page 6 of 12

1.1 SCOPE

This PTS covers all sampling and analysis work carried out by TPLs throughout any PETRONAS
HCU/BU/OPU/JV/Project. Adherence to this PTS is nevertheless highly recommended to in-
house sampling and analysis programs and projects.

1.2 GLOSSARY OF TERMS

1.2.1 General Definition of Terms & Abbreviations

Refer to PTS 00.01.03 for PTS Requirements, General Definition Of Terms, Abbreviations &
Reading Guide.

1.2.2 Specific Definition of Terms

No Term Definition

1 Chain of custody A protocol (document) developed to provide a


legal record of the persons having contact with
a sample from the moment of collection to
final disposal.

2 Competent personnel PETRONAS staff with sufficient relevant


technical knowledge.

3 Quality assurance (QA) A set of processes implemented in a formalised


system for the purposes of evaluating the
technical adequacy of sample collection and
laboratory analysis activities.

QA activities start before samples are collected


and continue after laboratory analysis are
completed.

4 Quality control (QC) The process for obtaining data that are
accurate (precise and unbiased),
representative, comparable and complete. It
includes activities such as identification of
sampling and analytical methods, calibration
and standardisation, and sample custody and
record keeping. Audits, reviews, and complete
and thorough documentation are used to verify
compliance with predefined QC procedures.

QC is an aspect of QA.
Table 1.1: Specific Definition of Terms

Internal
PTS 16.63.01
THIRD-PARTY LABORATORY DATA QUALITY MANAGEMENT March 2017
Page 7 of 12

1.2.3 Specific Abbreviations

No General Abbreviation Description

1 CoA Certificate of analysis

2 CoC Chain of custody

3 HCU/BU/OPU/JV Holding Company Unit/Operational Unit/


Business Unit/Joint Venture

4 PTS PETRONAS Technical Standard

5 QA/QC Quality assurance/quality control

6 SOP Standard operating procedure

7 TPL Third-party laboratory


Table 1.2: Specific Acronyms

1.3 SUMMARY OF CHANGES

This is a new PTS.

Internal
PTS 16.63.01
THIRD-PARTY LABORATORY DATA QUALITY MANAGEMENT March 2017
Page 8 of 12

2.0 DATA MANAGEMENT PROCESS

The data management process can be divided into: Contractual Phase, Sampling &
Transportation, Analysis & Reporting, and Record Keeping. Further details of the four parts
are provided in the subsequent subsections and outlined in Figure 1 below.

Figure 1. Data management process outline

2.0.1 CONTRACTUAL PHASE

The following requirements will be mandatory for a TPL to be awarded a contract by a


PETRONAS HCU/BU/OPU/JV/Project for a sampling and/or analysis activity:

i. The TPL shall establish the methodologies and protocols, which may be in the
form of standard operating procedures (SOPs) and shall be pre-approved by
competent personnel (see definition) at the PETRONAS HCU/BU/OPU/JV/Project.
If the HCU/BU/OPU/JV/Project requires technical clarification/consultation, any
member of a relevant Skill Group and/or Community of Practice shall be consulted
for advice;

ii. The TPL will outline the Quality Assurance/Quality Control (QA/QC)
protocols/procedures in place for the relevant analysis, which shall also be pre-
approved by competent personnel at the PETRONAS HCU/BU/OPU/JV/Project;
and,

iii. In order to ensure transparency, no part of the analytical process is confidential


to PETRONAS and any stage of the process can be subject to audits.

2.0.2 SAMPLING & TRANSPORTATION

Unless the sampling and transportation events are carried out by the TPL personnel, the
implementation of the following requirements during the sampling and transportation phase

Internal
PTS 16.63.01
THIRD-PARTY LABORATORY DATA QUALITY MANAGEMENT March 2017
Page 9 of 12

shall be the responsibility of the respective PETRONAS HCU/BU/OPU/JV/Project competent


personnel following instructions from the TPL:

i. Health, safety and environmental aspects of sampling and analysis;

ii. Adequate collection, bottling and preservation of sample(s);

iii. Inclusion of QC samples where relevant e.g. field blank, field duplicate, trip blank,
etc. for environmental sampling; and,

iv. Storage and transportation.

The advice from the TPL on Items i through iv shall be sought by the PETRONAS
HCU/BU/OPU/JV/Project prior to the sampling event and a copy of the written advice shall be
stored as part of the testing documentation.

Additionally, a copy of a CoC form shall be signed by every person handling the sample for any
period of time e.g. sampler (from HCU/BU/OPU/JV/Project or TPL personnel), courier
(delivery), receptionist (TPL). All CoC copies representing the ‘change of hands’ of the
sample/s shall be kept by the respective PETRONAS HCU/BU/OPU/JV/Project. An example of
a CoC is provided in the Appendix 1, although similar formats shall also be accepted.

2.0.3 ANALYSIS & REPORTING

The analysis and reporting phase covers the execution of the assessment and the generation
of the report. Responsibilities are assigned as per the following:

i. The TPL shall perform the analysis of the sample/s strictly as per technical
documentation assessed and agreed during the contractual phase.

ii. The generated test report/certificate of analysis (CoA) shall be always dated and
– physically or electronically – signed, and shall include all QC data related to the
day-to-day activities carried out within the scope of the overall QA program of the
TPL e.g. laboratory blank, laboratory duplicate, surrogate, matrix spike, laboratory
control sample, etc.

iii. The test report/CoA, along with the final signed CoC form, shall be sent by the TPL
to the HCU/BU/OPU/JV/Project, which shall ultimately ensure with the help of
competent personnel that all conditions pre-arranged at the contractual stage
have been met. If no repetition is deemed necessary, the report/CoA along with
all copies of the signed CoC forms, shall be stored and digitalised whenever
possible by the HCU/BU/OPU/JV/Project.

2.0.4 RECORD KEEPING

The document retention period by the TPL should be at least 5 years and document
elimination shall be carried out only prior PETRONAS HCU/BU/OPU/JV/Project approval.

Internal
PTS 16.63.01
THIRD-PARTY LABORATORY DATA QUALITY MANAGEMENT March 2017
Page 10 of 12

Unless required by regulation or internal requirements, the retention period for documents
by the HCU/BU/OPU/JV/Project shall be 7 years.

Internal
PTS 16.63.01
THIRD-PARTY LABORATORY DATA QUALITY MANAGEMENT March 2017
Page 11 of 12

3.0 BIBLIOGRAPHY

In this PTS, reference is made to the following Standards/Publications. Unless specifically


designated by date, the latest edition of each publication shall be used, together with any
supplements/revisions thereto:

PETRONAS TECHNICAL STANDARDS & GUIDELINES

Index to PTS PTS 00.01.01


Requirements, General Definition of Terms, Abbreviations PTS 00.01.03
& Reading Guide

Internal
APPENDIX 1: CHAIN OF CUSTODY FORM TEMPLATE
CHAIN OF CUSTODY FORM
Project Name (Description): Project/Protocol Number (If applicable):
Sampling Date: Sampling Time:
Name of Sampling Personnel: Signature of Sampling Personnel:

(S) Soil/ (L) Liquid/ (G)


Analysis Required (Please write)

If yes, add details in


Filtered/Unfiltered

Preservation (Y/N)
Or Other (specify)

comments
Matrix

(F/U)
Gas
Sample ID COMMENTS

Preservation
Number of
containers
S/L/G/other
Matrix
Hand Over by Received by COMMENTS / REASON FOR
Time/Date: Time/Date:
(Name/Signature/Position/Company): (Name/Signature/Position/Company): TAKING SAMPLE

NOTE(S): This template is provided as part of the PTS 16.63.01 for guidance purposes.
Each person involved in the sampling/transport chain must retain a signed copy. As there may be more than one hand over, additional printouts of this form should be made.
Add any further details as required. If field is not applicable, please write N/A.
Internal

You might also like