Professional Documents
Culture Documents
Quality Assurance Process Plant Projects
Quality Assurance Process Plant Projects
Second Edition
Distributed by
GULF PUBLISHING COMPANY
P.O. BOX 2608
Houston, T X 77252-2608 USA
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Printed in the UK by Henry Ling Limited, The Dorset Press, Dorchester DTI IHD.
ii
Acknowledgements
The first edition of the guide was prsduced in 1992 under the direction of the
Institutionof ChemicalEngineersby a Working Party comprised of the following
company representatives:
Dr G.G. Cutts
Mr M.J.P. Garrett
Mr D.W. Maidment
Mr A.T. Markham
Mr F.J. Owen
Dr J.S. Parkinson
Mr A.W.J. Petherbridge
Mr R.P. Willis
They would also like to thank Mr A. G. Simrnonds of John Brown Engineers &
Constructors Ltd for his contribution on the quality assurance of software.
The Institution expresses its thanks to these members for their individual
contribution.
In this second edition, the authors have not only updated the guide but have also
addressed the increasing demands, requirements and controls of information
transfer, which is today having a much greater impact on the success of engineering projects.
Personally, one of the most rewarding aspects of this publication is that two of
its contributors were students of mine when I was a young lecturer at the
Borough Polytechnic, London in the early 1960s.
It therefore gives me great pleasure to support and recommend this second
edition of the guide which continues to promote the Institution of Chemical
Engineers in the pursuance of total quality.
Professor John Garside
Contents
Page
Introduction
How to use the guide
1. Scope
2. Normative references
3. Definitions
4. Quality system requirements
4.1
4.2
4.3
4.4
4.5
4.6
4.7
4.8
4.9
4.10
4.11
4.12
4.13
4.14
4.15
4.16
4.17
4.18
4.19
4.20
4
5
Management responsibility
Quality system
Contract review
Design control
Document and data control
Purchasing
Control of customer-supplied product
Product identification and traceability
Process control
Inspection and testing
Control of inspection, measuring and test equipment
Inspection and test status
Control of nonconforming product
Corrective and preventive action
Handling, storage, packaging and delivery
Control of quality records
Internal qualifyaudits
Training
Servicing
Statistical techniques
Text references
vii
Introduction
Quality Assurance and Total Quality Management have become recognized as
the modern techniques for improving company competitiveness and profitability. In the UK, the initiative for improving the performance of manufacturing
industry was taken by the government in the early 1980s when it launched its
National Quality Campaign. The vehicle used for this campaign by the DTI was
BS 5750: 1979: Quality systems1. Emphasis was given to its use by government
departments insisting that their suppliers became registered to this Standard if
they were to continue to receive their business. In the early years most of the
emphasis on its implementationwas in the mechanicaland electricalcomponent
sectors serving the car industry.
In the mid 1980s chemical manufacturing companies started to receive
demands from customers using products destined for the motor industry to
apply the Quality Assurance system BS 5750: 1979 to their production procedures. These companies found difficulty in interpreting the Standard for chemical manufacture to such an extent that BSI and the Chemical Industries
Association set up a working party in 1986 to prepare guidance on its consistent
interpretation. This was issued in 1987 as BS 5750: Guidelines for Use by the
Chemical Industry 2. It was published to coincide with the re-issue of the Standard
as BS 5750:1987 and IS0 9000,1987, to emphasize that theupdated Standard had
received international recognition. This was an important step for the UK to
achieve, given its historically poor reputation for quality. Since that time many
other countries have accepted the Standard. Of particular sighcance was its
recognition in Europe as EN 29000 and the publication b CEFIC in 1991 of EN
29001, ISO9001:Guidelinesfor Use by the Chemical Industry which superseded the
1987 document previously mentioned.
The 1987 standard, like the 1979 original, was in three parts:
BS 5750: Part 1, IS0 9001, Specification for Design/Development, Production,
Installation and servicing4;
5
BS 5750: Part 2, IS0 9002, Specification for Production and Installation ;
BS 5750: Part 3, IS0 9003, Specification for Final Inspection and ~ e s t ~ .
In 1994 the International Standards Organisation published a revision of
IS0 9001 designated:
IS0 9001: 1994, Quality Systems - Model for Quality Assurance in Design,
Development, Production, Installation and ~ e r v i c i n ~ ~ .
This has superseded BS 5750: Part 1:1987 (whichhas been withdrawn) and
has been recognized in Europe (by CEN, the European Committee for Standardisation) as EN IS0 9001: 1994. In the UK, the British Standard isnow known
as BS EN IS0 9001: 1994. BSI stated the revision did not include any major
changes, but believed the wording needed to be improved and simplified to
make the Standard more relevant due to its increased application and scale of
usage. Details are given in BSI Quality Assurance Guide to the 1994 Revision of BS
5750, IS0 9000~.The IChemE guide has been revised to take account of the
changes made to IS0 9001: 1987 in the new IS0 9001: 1994.
All references in the guide to IS0 9001 mean IS0 9001: 1994; BS EN IS0
9001 1994 and EN IS0 9001.
The guide sets out to show how IS0 9001 may be applied effectively to a
process plant project from design to commissioning, when it would then be
operated for chemical manufacturing to IS0 9002, for which the most recent
guidance is given by CEFIC as mentioned previously.
In essence, the IS0 9000 series is a formalized quality assurance management system designed to ensure that quality is built into every stage of the
activity in hand. It moves away from the concept of quality control by inspection
and test at the end of the project. Implemented successfully, the Standard seeks
to improve performance continuously by learning from experience and exarnining reasons for complaints, discrepancies and failures and by building corrective
actions into the revised system to avoid their recurrence. In this way costs of
waste, rework, modification, blending and poor plant utilization are reduced
and customers' needs and expectations can be satisfied first time, every time by
constant improvement. An additional benefit, of particular importance to the
process industries, is that such a system strongly reinforces health, safety and
environment standards and procedures, like Hazop, by formally checking,
auditing and improving them on a regular, defined basis. The Institution places
great emphasis on these aspects of all systems relating to project management
and this is reflected throughout this guide.
Because the Standard relates to a quality system and not a product, it can
be applied to any activity, whether researching, designing, manufacturing,
servicing,consulting, building or constructing.Thus, many companies who have
seen the benefits of such a formalized system in manufacturing are applying the
same techniques to every aspect of a company's operation from personnel to
accounts and from telecommunications to marketing. This is a natural progression to Total Quality Management, TQM. Some large multinationalshave started
with a TQM policy and implemented the Standard as a step on the way.
EssentiallyTQM recognizes that every activity in a company can be regarded as
a 'process' with inputs and outputs which can be given a specification. Equally
important is that each activity or 'process' has a supplier-for example, of design
information- and a customer, both of whose needs and expectations must be
met if the process is to be specified with quality built-in to produce the required
output first time. The same procedures are applied to each process as defined in
the Standard.
Following on from the above, it is believed that the procedures involved
in the design, construction, commissioning and servicing of chemical plant lend
themselves to a Quality Assurance system that has the potential to achieve
substantial savings by reducing costly errors - that is, by building quality into
the design process itself. To this end, in 1989 the IChemE Engineering Practice
Committee (EPC)set up a working party to give guidance on how to implement
IS0 9001 in design offices.The purpose of the guide was to assist companies who
provide such services in interpreting the Standard for all phases of chemical plant
design through to its commissioning, when, hopefully, the company will be
registered to IS0 9002 for chemical manufacture. Many major contracting companies now have registration to IS0 9001. The guidance given here is intended
not only to help both contracting and operating companies in the chemical
process industry, which have their own in-house project design functions, to
achieve the benefits which a formalized Quality Assurance system provides, but
also those in the food, drink, pharmaceutical and building service industries.
There is no doubt that the benefits of Quality Assurance and TQM are real and
the techniques are here to stay. The guide will also prove beneficial to undergraduates during their design project and to graduates in small to medium sized
companies who have no special or dedicated expertise in Quality Assurance.
It is hoped that this guide will complement the long-standing IChemE
Model Forms of Conditions of Contract for Process Plants Suitable for Lum Sum
Contracfs (the Red ~ o o kand
) ~ Reimbursable Contracts (the Green Book)It', thus
advancing the confidence clients have in suppliers who use them.
Note: In the first edition of this guide the purchaser received a current copy
of IS0 9001 for direct reference. This enabled the publisher to reproduce Section
4 of the Standard in the margin of the guide under the title 'Abstract'. In response
to readers' suggestions, and since most now have access to the revised standard,
this practice has ceased.
1.
Scope
IS0 9001: 1994 Quality Systems relates to all the design, manufacture, supply,
installation, commissioning and servicing activities that determine the quality
and reliability of a process plant, as created by a multidisciplined engineering
project team to a specification agreed with a customer.
The design of each project has to identify and take account of the requirements of current legislation, International and National Standards and other
specifications that may be referred to in the design and by agreement with the
customer.
2.
Normativereferences
The references given in IS0 9001 are self-explanatory. Additional text references
are listed on page 70 of this guide.
3.
Definitions
Project manager
The person employed by the supplier, having the authority to direct the contract
and meet the obligations of the supplier to the customer, to fulfil the project
requirements. Within an organization, this person may have varying titles from
Chief Engineer to Managing Director or Chief Executive.
Quality
The totality of featuresand characteristicsof a product (process plant) or service,
that bear on its ability to satisfy the specified need.
Quality Assurance
All those planned and systematic actions necessary to provide adequate confidence that a product (processplant) or service will satisfy specified requirements
first time.
Quality Plan
A document setting out the specific quality practices, resources and sequence of
activities relevant to a particular product, service, contract or project. In the
context of this guide it comprises the project co-ordination procedure and
departmental work instructions.
Quality Policy
The overall quality intentionsand direction of an organization as regards quality
as formally expressed by top management.
Reliability
Ability of an item (plant)to perform a required function under stated conditions
for a stated period of time.
Sub-Confractor
The organization from which the supplier procures goods or services.
Supplier
The company - for example, contractor or engineering department - implementing the quality system and providing the goods or service to the customer.
Tender
Offer made by a supplier responding to an invitation to satisfy a contract award
to provide goods/services.
4.
4.1
Management responsibility
4.1.1
Quality policy
Guidance
The quality policy for any organization must have the total commitment of its
management to establish and maintain the quality system, which will ensure the
requirements of the customer are consistently achieved.
Once a clear commitment to a quality policy has been established, the Chief
Executive must delegate the responsibility and give authority to competent
persons who will ensure that the policy is fully understood, implemented and
maintained through its quality system.
The quality objectives for a process plant project should be that it is: 'fit for the
purpose' for which it is designed; it is completed within cost estimate; on
schedule and is reliable. It is also paramount that the plant is safe in operation
and that all potential hazards and risks have been identified and properly
controlled. It must be engineered to protect the health of the employees and the
public and not damage the environment.
Advisory procedures
For any organization supplying process equipment or services to IS0 9001 there
must be dedication to quality. This commitment must be total. It will emanate
from the Chief Executive and be transmitted through all levels of management,
engineeringdepartments and include the craftsmen and fitters. The responsibility for achieving it must be defined clearly within the company's Quality
Manuals. It is normal practice for a policy statement on quality assurance to be
issued by the Chief Executive and placed at the forefront of these manuals.
4.1.2
Organization
Adviso y procedures
Projects will always vary in size and complexity, so companies have to decide
whether they have sufficient engineering resources to undertake a particular
project or whether they should employ the services of an engineeringcontractor.
Equally, engineering contractors may wish to engage sub-contractors.In either
of these situations the Quality Assurance department must have the responsibility and authority to ensure that the requirements of the company's quality
system are achieved.
4.1.2.2 Resources
Guidance
Once a project has been sanctioned and the requirements specified, a detailed
engineering design will have to be undertaken. This will ensure that the process
plant is engineered into an efficient and safe operating unit. The resource needs
of any project will be dependent on the value, the complexity, location and time
schedule. Therefore the project manager must ensure that the manpower
resource is qualified and trained. In addition, craftsmen must be competent and
skilled.
To assist the project manager he may require the services of a planning engineer
for resourceallocation. He willidentlfyany shortfall inmanpower for thevarious
engineeringdisciplinesfor support in both the design office and on site. On major
projects, failure to idenbfy reasonably accurately- the resources required can
lead to delays which may impact on quality. It is essential that systems and
procedures are in operation during all phases of the project to ensure it is
completed on time within budget, and operates to its technical specification
within the overall project scope.
Adviso y procedures
Project management will provide adequate resourcesand trained personnel (see
Section 4.18 Training, page 67) to undertake the detailed engineering and maintain the integrity of the installation. This may include qualified and trained
engineers, technicians and craftsmen to undertake the following:
heat and mass balances;
design calculations of a mechanical or process nature;
software applications;
Hazop and Hazan studies;
environmental impact assessments;
integrated pollution control (PC) authorization;
detailed drawings for construction;
inspection during installation and erection;
commissioning and validation procedures;
quality and safety audits.
4.1.3
Management review
Guidance
A management review is a systematic reappraisal of the quality system procedures and objectives and will identlfy where they can be improved, based on
experience, or if they require any amendments or minor changes. The latter may
arise for reasons such as staff changes, new legislation and new computer
techniques. The review should not be confused with a quality audit, which sets
out to establish that the organization as a whole is operating to the demands of
the company's quality system and procedures. The review will, however, consider the results of audits. The composition of the group formed to undertake
the review will depend upon the organization.
The frequencyof the reviews must be established based on how critical they are
to the product (process plant) quality. In addition to the quality system review,
an engineering contractor would probably examine each project on completion
and implement any changes as highlighted by deficiencies which arose during
the life of the project. An engineering department may consider the suppliers'
performance, with special regard to their compliance with the Quality Plan,
company standards and safety procedures. An example of this would be to
ensure that a supplier of process plant had complied with a customer's numbering system for items of equipment, valves and pipework. They may also wish to
consider any standards and procedures, and review these documents, together
with any others which are issued to suppliers, to ensure that plant installations
conform to company engineering policy, not only during construction but also
on completion, to minimize maintenance.
Adviso y procedures
The quality system has to be reviewed at defined intervals. It is wise to review
its key elements on a 3-6 month basis and other sections at least annually, with
a supplementary review at the completionof each project. Project team members
involved in reviews could be selected from:
project manager;
quality manager;
planning engineer;
process engineer;
systems engineer;
civil and structural engineer;
mechanical engineer;
electrical engineer;
building services engineer;
instrumentationengineer;
health, safety and environment advisor;
purchasing manager.
Management review must include an appraisal of the quality system currently
in operation, so the agenda would include topics such as:
quality policy and objectives;
improvements to the quality system;
documentationand software control;
changes in working practices;
customer complaints and correctiveactions;
audit reports;
corporate and future plans.
When a project management review is undertaken, items of discussion could
include:
project planning and organization;
variations to contract and cost control;
engineering rework;
customer complaints (where the customer may be either internal or external
to the company).
The review must be recorded and recommend to the Quality Assurancemanager
any action needed to amend the procedures in the Quality Manual or to improve
the quality of the engineering activities. Actions should be monitored to ensure
they are implemented and effective. Care should always be exercised in making
amendments so as to ensure that the instructions are clear and concise and that
ambiguities are avoided. Any obsolete documentation must also be removed.
Changes must be approved and authorized by nominated responsible persons
in accordance with document and data control and change procedures defined
in Section 4.5.3.
4.2
Quality system
4.2.1
General
Guidance
The quality system must be based on the principle of 'do it once, do it right',
which will ensure the efficiency and safety of any process plant project. To
achieve this the company will have its own approved standards and procedures
which reference other Internationalor British Standards and/or statutory regulations and act as reference documents against which the system can be tested
for compliance.For each project a Quality Plan should be produced which would
be based on the standards and procedures given in the Quality Manual. The
distinction between these is shown by the following descriptions and their
relationship within the quality system by Figure1, page 17.
4.2.2
Guidance
The Quality Manual covers the quality system procedures within the whole
operation of the organization with regard to Quality Assurance. This is often
written against the corresponding paragraphs of IS0 9001 Sections 4.1 to 4.20,
augmented as required by work instructions for the department.
The Quality Manual will be unique for each company and will recognize the
business environment in which the organization operates (being either a large
process engineering contractor or an engineering department - see Chapter 3
Definitions, pages 6-7).
A d v i s o y procedures
The Quality Manual should set out the quality policies, procedures and practices
within the organization. It may be found convenient merely to indicate the
existence and contents of the more detailed procedures which operate in other
departments. Each department may have its own proceduresand practices, and
specific parts of the overall quality system could be arranged as follows:
process and design engineering procedures;
procurement;
sub-contractor control.
4.2.3
Quality planning
Guidance
Quality planning sets out the specific quality practices, resources available and
sequence of activities relevant to a particular process plant project (see BS 4778:
Part 1 1987: 3.9"). Standards will be agreed prior to contract or detailed engineering design. Any standards having a subjective element would initially be
approved by a procedure acceptable to both the customer and the supplier. An
example of this would be the quality of surface finish for an item of process
equipment-for example, satin or mirror finish for stainless steel plate.
For each project the Quality Plan would normally make reference to the Quality
Manual and only describe in detail the exceptions to the quality procedures. The
Quality Plan will include, or refer to, Inspectionand Test Plans (ITPs)(seeSection
4.10 Inspection and testing, page 45).
When the process plant is commissioned and is handed over for production, the
Quality Plan should have established the plant 'pedigree', and could be used as
the basis for all future maintenance and plant inspections.
Adviso y procedures
The Quality Plan is specific for the total project and it is the compilation of all the
individual quality plans required for all plant items and equipment which are
specific to the project. Typical individual Quality Plans include:
plant fabrication;
building construction;
environmentalservices;
pipework fabrications;
equipment testing;
commissioning;
validation;
plant optimization (if applicable).
4.3
4.3.1
Contract review
General
Guidance
Contract review is the beginning of the design validation span of a project as
defined in Figure3,Section4.4.8, page 26. It is essential for the customer to specify
the project requirements and extent of supply as accurately as possible, because
it is on this information that the contract is based and the order accepted.
The intention of contract review is to ensure that the requirementsof the contract
are fully understood, that deliverables are identified, variances between tender
and contract are resolved and that the supplier has the technical, managerialand
manpower resources to complete the contract.
4.3.2
Review
Guidance
The review should consider:
The review procedure should ensure that clear agreement is obtained on the
precise terms ahd conditions which pertain to the contract, particularly for
export, where it is essential to establish which national legal system applies.
Legal advice for the preparation of such a procedure should be sought.
It is recommended that representativesfrom the project team should be involved
as early as possible in the project, preferably at the pre-contract stage, to ensure
they have a good understanding of the customer needs.
4.3.3
Amendments to contract
Guidance
Amendments to the contract must be reviewed promptly, with variation orders
issued and acknowledged.
All contract changes and additional work instructions raised during the contract
period must be strictly recorded and the customer advised promptly of the
impact of these variations on price, delivery and other factors affecting quality
- for example, reliability.
4.3.4
Records
Guidance
Contract reviews must be documented to ensure proper accountability is maintained. The records could be administered by a check-list procedure which
would assist proper accountability. They will be specific to equipment suppliers
and used to compare their performance with the original project programme to
monitor key completion and delivery dates.
Such records will provide objective evidence that the Quality Assurance procedures have been followed (seeSection 4.16 Control of quality records, page 64).
4.4
Design control
4.4.1
General
Guidance
This section of the Standard covers the design verification span referred to in
Figure 3, Section 4.4.8, page 26. Procedures for design control should recognize
that, in executing the design of a process plant, a supplier will need to draw on
the expertise of a number of engineering and other disciplines, whose activities
are co-ordinated by a project manager or project engineer. These disciplines
include all or some of the following, depending on the size and scope of the
project.
Technical functions:
chemical;
mechanical (including vessel, machinery, piping and plant layout specialists);
electrical;
instrument;
systems software;
civil and structural;
risk analysis and safety;
environmentalimpact;
building services;
quality assurance;
construction;
commissioning.
Other functions or departments:
purchasing;
non-destructive testing and inspection;
planning;
shipping - dimension constraints imposed by transportation routes and
regulations;
legallinsurance.
Quality Assurance depends not only on the quality of work produced by the
different disciplines, but also on the efficient co-ordination and interfacing of
their activities. Company procedures should address this requirement.
Adviso y procedures
In order to cover the whole range of activities it is recommended that the quality
system (seeSection4.2 Quality system, page 12) will require two levelsof written
procedures.These are:
standard procedures which apply to all projects and are referred to in the
Quality Manual;
supplementary procedures which are specific to a particular project and
written in the Quality Plan.
The Quality Manual and Quality Plan together form the quality system as shown
in Figure1.
The Quality Manual comprises:
Standard procedures which are not project-specific including:
QA System
4.2
Quality manual
4.2.3
Company
procedures
4.4.1
Quality plan
4.2.3
Departmental
procedures
4.4.1
Project co-ordination
procedure
4.4.1
Figure 1
Departmental work
instructions
4.4.1
- maintenance of registers;
design standards and codes;
checking and approval;
reporting;
maintenance of records;
and any other special requirements of the project not covered by these.
4.4.2
Guidance
This requires the supplier to set up an organization to give fu.1managerialeffect
to multi-discipline co-ordination and planning referred to in Sections 4.1.2.2 and
4.4.1, pages 9 and 16. In particular, the responsibilities across interdepartmental
functions need to be clearly defined. In practice this is equivalent to a project
manager (contractor or engineering department) setting up the project team for
a particular project within the overall organization of the company.
The supplier needs to ensure that within both the company organization, and
the project team, adequately trained and experienced staff are appointed for
specific projects to execute the level of responsibility assigned to them.
Adviso y procedures
A detailed plan should be drawn up at the commencement of every project,
identifying in a logical sequence the activities necessary to achieve the overall
project schedule. They are classified by department with responsibilities for the
activities indicated. These plans cover all relevant aspects of design, procurement, construction and commissioning, depending upon the company's contractual arrangement with the customer. The timing of key design reviews is shown
on the detailed plan. The project schedule may be presented in the form of a bar
chart or a planning network, consistent with the size and type of the project. For
major projects this activity will require the involvement of a specialist planner.
AU project plans should be approved by the project manager.
The project co-ordination procedure (part of the Quality Plan) should identlfy
those personnel with s u p e ~ s o r responsibiIities
y
for the project, plus any other
key personnel.
The departmental work instructions should assign other personnel to design
verification activities. They should be demonstrably qualified and experienced
for the assignment and level of responsibility undertaken.
The progress of the work should be reviewed regularly. Following these reviews
the overall project schedule should be updated to show the current situation and
the progress achieved on the plan to date. Actions resulting from these reviews
should be recorded.
4.4.3
Guidance
This recognizes the distinction between people and technical interfaces within
an organization. It requires the supplier to identify where these interfaces occur
and to have documented procedures to cover them. A typical, and generally
difficult, example is the interface between those responsible for piping and plant
layout and all other disciplines. There is frequent interplay between location of
equipment and its size or specification, which depends on detailed information
from manufacturers of proprietary equipment.
Aduiso y procedures
The organizational and reporting relationships of personnel assigned to a project
should be shown on an organization chart contained in the project co-ordination
procedure. Technical interfaces between each engineering discipline and the
method of review of design documents should be defined in a company procedure, with detailed implementation contained in departmental procedures.
These procedures should describe the scope and purpose of every design document produced, the originating department, the source of input data and the
departments to whom the document is issued. The number of review stages and
the method of review should also be defined.
4.4.4
Design input
Guidance
The availability of design data, and its state of development at the commencement of a project, can vary considerably. Typically, design data will originate
from the customer, technology licensor, pilot plant trials, laboratoryexperiments
or from the supplier's knowledge and experience.
Procedures should exist to ensure that designers are kept up to date with
regulatory requirementsand to ensure conformity with these. At project concep
tion, there should be liaison with the appropriate authorities to confirm that the
regulatory requirements have been correctly interpreted. It is recommended that
a database enquiry is made to ensure that the latest regulatory documents,
standards and codes of practice are applied.
It is important that the starting data and source are documented, and that
suitably qualified staff review its content, iden* where essential data is missing
or ambiguous, and resolve shortcomings with its originator.
Adviso y procedures
The customer will define plant capacity and product quality, mandatory standards and other essential documentation.Such requirements, where the supplier
is a contractor, should form part of the contract reviews as described in Section
4.3 Contract review, page 13.
As the design progresses, additional input data will be received from the
customer, licensor, vendors, consultants and other bodies, and this data should
be similarly documented and reviewed for accuracy and completeness.
4.4.5
Design output
Guidance
Company and departmental procedures define the types of documents (see
Section 4.2 Quality system, phge 12) that should be produced in order to meet
Identify those characteristics of the design that are crucial to the safe and proper
functioning of the product
Safety reviews should be performed routinely to identify potential hazards and
the measures taken to safeguard plant, personnel, the general public, the environment and the integrity of the manufactured product. Responsibility will
normally extend to the provision of operating and maintenance manuals both of
which should contain instructions on safe working practices.
(c)
4.4.6
Design review
Guidance
For any major project the design review is one of the most important stages to
ensure its successful completion. At the contract review stage the project is in
embryonic form and the design requires to be developed and controlled continually to ensure it meets the demands of the specification.Unlike mass production
processes, which manufacture product on a repetitive basis, a process plant
project is often a 'one-OW. Sometimes the project may be similar to an earlier
installation but even then the location, climatic conditions or available utilities
may differ. Therefore, the supplier has to ensure that the detailed engineering
design, as issued for construction and installation, is suitable for purpose. This
requires to be monitored by careful reviews.
Input data (see Section 4.4.4 Design input, page 21) may be incomplete prior to
the commencement of design, as it is often not technically necessary nor commerciallyviable, to gather all design information prior to contract. This generates
the need to gather additional technical information for the design to proceed.
Changes which take place must be checked for their impact on the total design
which must be managed and dove-tailed together. If this is not co-ordinated by
the project manager then the individual discipline engineers will work in isolation of each other and this will result in 'clashes of interest'. A simple example
of this is if design reviews are not regularly undertaken, the space occupied
within a service duct could be allocated by both the electrical design section for
cable trays and the services engineer for ductwork, resulting in a clash of
hardware. These are relatively easy to amend at the design review but can be
expensive and time consuming to correct at the installation stage. The project
manager must ensure that the design is co-ordinated and misunderstandings
between disciplines are avoided. This will require continual vigilance as the
design progresses and good communications must exist between all the interested parties.
The design review should be seen as formulated stage inspection. During the
design phase it is extremely important that all representatives with any interest
in the design take an active and constructive part in the design review, such that
the right decisions are made as early as possible. Figure 2 on page 24 illustrates
typical input groups.
The role of the project manager is strategic for the whole project and would not
normally involve detailed engineering decisions. Decisions should be made at
the lowest possible levels providing that the basis of the information on which
the decisions are made is sound. Particular points of issue should be relayed to
the next tier of project management until they are resolved by the project
manager.
Figure 2
Design documentation must be checked and approved (see Section 4.4.1, page
16) but in addition and most importantly revisions and amendments must be
documented. The information arising from these changes must be quickly and
clearly communicatedto other engineering disciplinesand involved individuals.
The documentation should also clearly state who authorized the change and the
reason for it. Equally, any impact a change may have on capital cost and time
must be quickly estimated and forwarded to the project manager.
It is important that only valid documentsare used for design purposes; therefore
if changes are made and issued it is essential to withdraw the previousdocument
issue from circulation.When superseded documentsare retained they should be
clearly identified.
Adviso y procedures
The organization of a project team will consist of a group of experienced
engineers from various disciplines reporting to the project manager. He in turn
will report to an organization structure representing the customer. At the preliminary design stage when schematics are being prepared and developed -for
4.4.7
Design verification
Guidance
Written procedures should be used to ensure that the design is verified at
predetermined specific stages during the project, and that these stages are
defined in the project co-ordination procedure in the Quality Plan.
Adviso y procedures
All design verification activities should be documented. This requirement imposes the need for all significant design documents to bear 'drawn by', 'checked
by' and 'approved by' entries, and for review meetings to be minuted. Such
review meetings require actions by named individuals or departments and a
follow-up procedure should ensure that action is taken.
The design verification measures should include:
checking in accordance with the departmental procedures and departmental
work instructions;
design reviews by engineering management, project management and construction management;
planned and regular project and company internal quality audits;
checking of calculations by alternative means, if appropriate;
verification of software, for in-house use;
review of past experience with similar projects;
pilot plant trials/small-scalelaboratory tests;
hazard evaluation tests.
Design validation
4.4.8
Guidance
This is a new clause in the 1994 revision of IS0 9001. A diagram illustrating the
differences and connections between verification and validation is given in
Annex A of the BSI Quality Assurance Guide to the 1994 Revision of BS 5750, I S 0
9000~.
It is reproduced here as Figure 3.
review
Design
input
4-* I
Design
output
Design
plan
Responsibilities
1
I
~nterfaces
Verification
Validation
in use
Figure 3
A diagram illustrating the revised design control model. (Annex A from
the BSI Quality Assurance Guide to the 1994 Revision of BS5750, IS0 9000~is
reproduced with the permission of BSI.)
Design validation covers the need to establish that the finished process plant
meets all the requirements of the contract. This means that the Quality Plan must
include procedures for testing all equipment to ensure that design parameters,
specificationsand outputs have been complied with. It will include, for example,
the criteria for acceptance of guarantee runs by the customer.
Briefly, validation encompasses the design verification procedures by extending
them to cover commissioning and handover criteria of the finished plant to the
customer. It covers Sections 4.3 to 4.15 of the Standard.
Design verification compares the design input with the design output at each
stage of design control - see Section 4.4, page 16.
Design validation and verification together defirie how quality is built into the
product throughout the project so that the product is right first time to customer
requirements- the essence of Quality Assurance.
Part of design validation is to identify the critical components and functions.
Certain projects may require a lesser degree of design validation than others.
Validation is extremely critical within, for example, the nuclear and phannaceutical industries where the products of processes are life threatening, but takes a
much lower profile on projects such as mineral treatment (for example, gravel
extraction).
Advisoy procedures
The completed plant design will be validated on completion of the following
stages which will be encompassed within the Quality Plan.
(iii) Pre-commissioning
1
Pre-commissioningis the period when the installation is checked for completeness and the equipment is test run and prepared for operation as far as practicable to ensure it is safe to receive and process feedstock.
Such test running and preparation of individual items of equipment or systems,
referred to as functional testing, is normally performed using clean water, air or
inert gas as substitutesfor process materials.
At the conclusion of this phase, which may partly overlap the mechanical
completion period, the plant is said to be 'ready for ccomrnissioning'. At this
point the plant is ready to receive normal feedstock.
fiv) Commissioning
Commissioning begins when normal feed is admitted for the first time to the
plant. During commissioning, the plant throughput is adjusted to design operating conditions to give a period of full production prior to the demonstration
of performance tests.
(v) PelfOrmance Tests
Known also as guarantee or warranty tests. These are technicallysupervised and
recorded tests which verify that plant, systems or equipment within a plant meet
the performance guarantees in accordance with the contract. Once mutually accepted they conclude the design validation span referred to in Figure 3, page 26.
4.4.9
Design changes
Guidance
Written procedures should be established and maintained for the identification,
documentation and appropriate review and authorization of all design and
software changes and modifications. Proceduresshould ensure that the implications of change in tenns of safety, design effort required, cost and time are
considered, documented and authorized.
Advisoy procedures
There is considerable potential for change to affwt adversely the quality of the
design, unless it is effectively managed. Adverse effects can be created by
additional work causing a dilution of resources, or by inadequatedissemination
of change information throughout the design team. Even with adequate distribution of change documentation, effective action following the change cannot
be assured unless there is a systematic review procedure to follow up all actions
to completion. Changes to documentsis discussed in Section 4.5.3 Document and
data changes, page 31.
Related written procedures:
change control;
safety review;
softwarecontrol.
4.5
IS0 9001 accepts that documents, data and records may be in any media - for
example, hard copy, electronic and microfiche - but does not deal with the
inter-relationship between Quality Assurance and information technology (IT).
Software plays a critical part in most quality systems and close attention must
be paid to ensuring its suitability and quality. Quality Assurance of software is
~
best practice for a
described in IS0 9000-3'~,but the 'Tickll" ~ u i d e 'describes
quality management standard for development and validation of software. It is
a standard devised by IT professionals with DTI and British Computer Society
support. IS09000-3is included in part 2of the 'TickIT' Guide. Readers are advised
to refer to this publication for more detail.
4.5.1
General
Note: In the 1994 revision7, 'data' has been added to the title of this section. For
any process plant project, the flow of accurate and relevant information must be
quickly distributed to maintain the completion schedule. Controls should encompass documents and drawings from external origins such as the customer
and statutory bodies and those generated within the project. The data may be
received in any form such as hard copy or electronic media.
The Standard demands procedures for the contrbl of all documents and data
relating to the requirements of the Standard itself, as well as for the project. It
includes the quality system documents as described in Section 42, page 12.
4.5.2
Guidance
It is important that an effective system of document numbering and control is in
place from the early stages of a project. This is when many of the documents are
initiated, yet it may be a time of rapid change as the design concepts are
developed. The controls also apply to software.
For many design organizations there are sufficient dissimilarities between projects or types of projects that it is impractical to develop an all-embracing single
system for document control. To overcome this difficulty a two-tier system of
document control is recommended:
(a) they are issued appropriately and to locations (for example, onsite) where
the functions are being performed;
(b) obsolete documents are promptly removed from use and are stamped or
otherwise identified as 'obsolete' if retained for record purposes;
important documents which are retained for future reference-for exam(c)
ple, soil reports - should be identified and archived. This data could then be
placed on an electronic database for retrieval.
Adviso y procedures
Documents should be initiated, prepared, approved and issued in accordance
with written procedures. Not all documents are prepared 'in-house' under such
control, and documents from external sources - for example, vendors' or
4.5.3
Guidance
It is ideal if changes to documents and software are reviewed and approved by
the same functions that performed the original review and approval. Where
practicable, the nature of the change should be identified in the documents or on
attachments. For example, changes to drawings may be highlighted by drawing
a cloud or bubble around the change, and changes to text may be highlighted by
the use of a revision number or letter in the margin. Alternatively, change lists
can be prepared as an attachment.
Adviso y procedures
I
Registers of documents and software should be maintained, i d e n w n g the
current revision (or issue)and date. Company and departmental procedures are
not project-specific and will normally be expected to change infrequently. However, drawings and specifications in use on a particular project will be subject to
frequent updates. Such documents are often initiated at a 'preliminary' status,
and ultimately be raised to 'for purchase' or 'for construction' status. Registers
of project documentation should contain entries defining the status of each
document.
The project schedule (seeSection 4.4.2 Design and development planning, page
19) details the timing of the issue, updating and re-issue of design documents.
In addition to the planned re-issue, documents should be re-issued after a
practical number of changes have been made or if even a single, but significant
change has been made. Minor changes to the design maybe found to be necessary
during the constructionand commissioning phases of the project.It is important
that neither health, safety, environment nor design intent should be compromised through unauthorized changes. Written procedures should address the
feedback of information from site, the authorization of any changes found to be
necessary, and the production of as-built drawings for record purposes.
Related written procedures should cover:
initiation, preparation, approval and issue of company and departmental
procedures;
change control;
production of project co-ordination procedures;
site feedback of engineering matters;
software change reviews.
4.6
Purchasing
4.6.1
General
Guidance
The term 'purchased product' as used in IS0 9001 refers to the procurement of
materials or services for inclusion in the supplier's own product or senices.
Technical interfaces with sub-contractors of equipment should be managed by
specialist engineers preparing detailed specificationsand monitoring the resulting design output to ensure compliance. This point is amplified in Section 4.4.3,
page 20 and Sections 4.6.2 to 4.6.4, pages 33-39. The ultimate customer or user
might himself regard the term 'purchased product' as being the process plant or
senices provided by the supplier. The customer need not, however, regard
himself as lacking a framework for ensuring the adequacy of what to him is
'purchased product'. A suitable contract could be taken from the Institution of
Chemical EngineersModel Forms of Conditions of Contractfor Process Plants Suitable
for Lump Sum Contracts (Red ~ o o kor
) ~Reimbursable Contracts (Green ~ook)".
Frequently the contract is not a stand-alone document, and the final agreement
may incorporateaspects of the invitationto bid and the supplier's tender. Where
the possibility of conflict between documents exists, the contract should clearly
state an order of precedence.
Advisory procedures
Procedures should be applied both to individual items of equipment, serving
mechanical, electrical, control or other functions, and also to materials which are
usually referred to in the industry as 'bulk materials' - that is, material which
does not normally have to be installed in a unique location. Examplesare piping,
pipe fittings, cable, cable trays and reinforcing bar.
The first step is to iden* suitable vendors and sub-contractors (see Section
4.6.2 Evaluation of sub-contractors).The next step is to analyse the bids, both
4.6.2
Evaluation of sub-contractors
Guidance
The term dsub-contractors~
should be regarded as a general term embracing
anyone who provides goods or services to the supplier (see also Chapter 3
Definitions, pages 6-7). Companies with a high level of activity in design and
Advisory procedures
(i)
Categorization
It is recommended that sub-contractors should be suitably categorized within
their own areas of technical and commercial activity.
For example, a four category system could be employed:
8
3
Critical purchases
(a)
(a) or (b)
Cb)
Non-critical purchases
(c)
(a) or (c)
(a)
It should additionally be noted that there may beg requirement for third party
inspection - for example, a statutory requiremeAt for steam raising plant, or a
requirement imposed by the customer or an insurer. In locations outside the UK
there may be additional mandatory requirements.
4.6.3
Purchasing data
~~
Guidance
Purchasing documents will normally consist of a technical specification s u p
ported by general specifications (if applicable)and a commercial section relating
to validity of tender, cost, delivery, guarantees, scbpe of supply, the company's
and the customer's right to access for inspection purposes and other agreed
conditions of purchase. Specifications will sometimes unavoidably contain information of a confidentialnature, in which case there may be a need for a secrecy
agreement to be included.
Purchasingdocumentsshould state clearly the data and drawings to be provided
to and by the supplier or sub-contractor, and the time schedulefor the provision
of this data.
Adviso y proceduws
It is customary that, in order to minimize the chance of ambiguity or the omission
of important information, a company should develop standard forms for the
specification of all classes of equipment and materials normally encountered on
process plant or specific to the company's line of business.Such forms may exist
as pre-printed paper or, as is increasingly the case, on computer.
All equipment should be provided with a unique title and/or reference number.
Bulk material components should be specifically identified. It will frequently be
appropriate to append to the equipment specification, information and specifications of a more general nature which are applicable across the project. Such
information and specificationsshould describe, for example:
climatic conditions;
availability of utilities and services;
standards for design construction quality and the environment (effluents,
emissions, noise);
painting;
insulation;
inspection and test requirements;
delivery instructions.
Each specification, whether specific to a particular item of equipment or of a
generalnature,should be annotated withanissue (or revision)letter (or number),
dated and paginated.
Each specification should be signed as 'prepared by', 'checked by' and 'approved
by' in accordance with company procedures, in order to ensure that documents
are reviewed and approved at an appropriate level before being released for
purchasing.
Related written procedures should cover:
numbering of equipment and materials;
preparation of technical specifications;
standard conditions of purchase;
the issue of purchase orders.
4.6.4
Guidance
I
Whilst brief definitions are given in Chapter 3, it is appropriate to define and
explain here some of the t e r n used in more detail to avoid confusion. In the
supply chain, many elements of that chain have a customersupplier relationship, but two of these relationships can be highlighted as being of particular
relevance. They are shown diagrammatically in Figure 4. For example:
(i) The ABC Chemical Company is the customer of the DEF Contracting
Company (the supplier), to whom equipment is provided by the GHI Pump
Manufacturing Company (the sub-contractor). Similarly the supplier could be
an internal engkeering department within the ABC Chemical Company.
Customer
ABC Chemical Co
Contractor
DEF Contracting Co
Sub-contractor
GHI Pump Manufacturing Co
Sub-contractor
JKL Seal Manufacturing Co
Figure 4
~ustomer/contractor/sub-contractor/supplh
matrix of relationships.
37
Alternatively:
For critical items an individual Quality Plan is prepared and acceptance criteria
agreed prior to manufacture. A stage inspection procedure identifies the 'hold'
points and the acceptance authority will venfy that the equipment has been
produced in accordance with its specifications.
For a process plant project, the sub-contractor's premises could be either a
specific manufacturing unit or an on-site, temporary construction facility. In
either situation, the supplier must satisfy himself that the sub-contractor's facilities are adequate and systems are in place which venfy the quality and ensure
that the product produced is in accordance with the purchasing document.
Particular attention must be paid to project-specific, onsite, temporary premises.
Since these are not permanent establishments, channels of communicationmust
be clear and acceptance levels defined.Strict adherence to safety proceduressuch
as hot work permit and permit-to-work must be enforced.
For specific items of equipment, it may be necessary for not only the customer
to inspect, but also his representative. An example of this would be the stage
inspection of a pressure vessel by an independent insurance inspector to venfy
that the equipment has been constructed in accordance with the design and
fabrication code.
Any customer inspection would not absolve the supplier of his overall responsibility for the supply of individual items of equipment or the plant installation.
Adviso y procedures
The Standard is very clear with regard to the verification of components such as
pumps, but Sections 4.6.4.1 and 4.6.4.2 also apply to on-site construction and
equipment servicing. Figure 4, page 37, gives a graphic interpretation of the
relationship between customer, supplier and sub-contractor, to help the reader
clearly understand the supply trails which exist in the execution of a process
plant project.
4.7
Guidance
The use of 'customer-supplied product' (often referred to as 'free issue material')
is a common practice within an engineering project and frequently affords
benefits. For example, the customer might provide electric motors to all of his
sub-contractors who are supplying pumps or other items of equipment. Alternatively the customer might supply components such as valves from his own
stores to ensure uniformity across his production site.The supplier will normally
of customer-supplied
be responsible for the control, safe-keeping
product after receipt.
II
If equipment, such as valves or motors, is supplied
by the customer to a
contractor then care should be exercised regarding the warranty covering the
items supplied.
I
the impact of failure of such items after commissioning and during the process
plant warranty period.
A d v i s o y procedures
The relationshipsbetween 'supplier' and 'customer' are defined in Section 4.6.4
and Figure 4, page 37. The customer should provide documentation to the
supplier for the identification of material, whether provided to a sub-contractor
for incorporation in plant or equipment, or provided directly to site. It should
include data to enable the recipient to verify that material is to specification and
instructions on storage and installation, which will ensure that the quality of the
process plant is maintained.
Related written procedures should cover the following (see also Section 4.15
Handling, storage, packaging and delivery, page 60):
stores stock control;
equipment handling on-siteloff-site;
packaging;
nonconfonnances.
4.8
Guidance
In the context of the design and supply of process plant, 'product' should be
regarded in very broad terms as comprising the design (that is, drawings,
calculationsand specifications),procuring equipmentand materials required for
the whole project and eventually installing and commissioning the complete
plant.
Requirements for traceability are determined by the operating conditions, reliability demands, the nature of the equipment and the materials of construction.
These will be defined by the design, specified by procurement, confirmed by
inspection, and registered by documentation, and are an integral part of the
Quality Plan.
Adviso y procedures
(i)
Design
All items of equipment should be provided with a unique title and/or reference
number (see Section 4.6.3 Purchasing data, page 35). This can be done by
allocating identification numbers to items of equipment, instruments and pipelines. Schedules should be maintained and regularly updated.
Bulk materials (described in Section 4.6.1 Purchasing, page 32) should also be
adequately identified, specified and quantified, which is customarily referred to
4.9
Process control
Guidance
Note: The term 'process' within the text of IS0 9001 refers to the stages in the
design, manufacture, construction, installation and commissioning of either a
part, component or assembly of the plant. In this context it does not refer to the
control of the chemical process for which the plant has been designed and
constructed.
Construction, installation and commissioning of a process plant is very different
from operating a repetitive production process where operating conditions and
acceptance parameters are well known. Process plants are often either 'one-off
or improvements to existing plant and technology, possibly involving novel
design techniques.By their very nature they are oken required to function under
arduous conditions of temperature and pressure and in corrosive environments,
sometimes working at the boundaries of technology. The materials, technology,
and service conditions used may not, therefore, be fully understood by other
than a few experts or specialists. Such plant is also inherently costly and consequential loss arising from malfunction can be high, both in direct cost and in
health, safety and environmental terms.
It would, however, be wrong to assume that all items of plant require the same
detailed level of control. Whilst all items of the plant must function correctly, not
all will be highly stressed, operate in harsh environments, require high levels of
integrity or undergo complex manufacturing processes. Project planning is
essential but the degree of detail to be specified during the construction and
installation stages will depend on the complexity of tasks, operating needs,
potential hazards, safety and the skill and knowledge of personnel available for
carrying out the work. When these factors could result in failure to meet the
specified quality, the performance and safety of the plant could be jeopardized.
The activities should be conducted in accordance with written procedures by
competent personnel against which progress can be monitored. It is this provision of written instruction for the management of design, manufacture, installation and monitoring that is generally referred to as controlled conditions.
The supplier must review the design, manufacture and installation schedule to
identify and plan the controls required for the critical stages and supply of key
items of plant, either in part or as a whole, which demand controlled conditions.
The review should include maintenance procedures.
It may not always be possible to show by testing that the completed plant item
or installation of components meet the required quality level. Vessel parts may
be inaccessible, and not amenable to testing without destroying its integrity.
Similarly, bulk items for which100%testing may not be practical will still require
a high degree of planned inspection to ensure material quality (see Section 4.20
Statistical techniques, page 69).
For example, the Quality Plan for closed vessels must include the stage inspection
for internal welds which cannot be verified after closure. Final inspection may
establish the coating thickness and colour of paint but will not confirm that
pre-treatment, surface preparation and inter-coat time were to specification. A
similar situation will hold true for rubber and glass lining. Heat treatment plants
produce timeltemperature graphs, but these do not show the location of materials within furnaces, the siting of thermocouples or record furnace atmosphere
conditions for critical treatments. Calibration and maintenance records must be
available to ensure the reliability of the process.
Procedures must be established to speclfy fully: the way in which the activity is
to be carried out; when and how verification of quality is to be assured and
approved; and how the material is released before further work is undertaken.
Proceduresshould include not only the manner in which manufacture, installation and testing are conducted but also how manufacturing, test materials and
equipment are to be controlled. In addition procedures may speclfy the qualifications required of operators and Quality Control personnel, together with the
record of test results and certification that must be established to prove that
quality aims were achieved.
Advisoy procedures
Written schedules, method statements and departmentalwork instructions form
part of the Quality Plan (see Figure1, page 17) and will specify how, and in what
sequence, tasks will be carried out. They will define practices and processes; state
standards of workmanship, skill and knowledge levels; speafy final quality
levels, acceptance parameters for mitical characteristics, and the authority
needed to validatelaccept the finished product. Again particular emphasis
should be given to health and safety working practices and to environmental
protection in the documentation. Control of such documentation is defined in
Sections4.4.1, page16 and 4.5, page 29. Activitieswhich require control are listed
below and require procedures for identification, filing and retrieval.
Training of personnel:
-skills (for example, welding);
- knowledge (technical education);
-qualification;
Special projects-these will include:
-installation;
-handling and storage;
-inspection and test plans;
-testing procedures/sampling;
Manufacturing processes;
Software application/development;
Control of test and inspection equipment;
Acceptancelrejection criteria;
ScrapIreworWrepair practices;
Certification requirementslcertifying authorities;
Records to be generated;
Equipment maintenance records.
Any special process associated with a project should be specified in the Quality
Plan. Special processes fall generally into two categories; those related to either
manufactureand installation, or verification activities like inspectionand testing.
Both these categories will be covered in the Quality Plan - that is, in the project
4.10
4.10.1 General
Documented procedures will be in place for the inspection and testing activities
of the supplier.
These procedures will be referred to in the Quality Plan even though they will
be part of the company procedures (for example, calibration methods)applying
to all projects and contained within the Quality Manual (see Section 4.2, page
12). When a new procedure is identified which is specific to the project in hand
it needs to be written into the Quality Plan.
Inspection procedures are written according to the level of inspection required.
Certain componentslparts may require higher levels of inspection than others
due to their critical nature. Procedures have a hierarchy of precedence gradually
increasing in detail as the risk of component failure rises. A simple example of
this could be the inspection of cooling water pipework. Normally this does not
require any detailed inspection procedures.However, if the cooling water duty
was associated with a nuclear facility then it would immediately be identified as
a critical component and strict inspection procedures enforced.
Inspection and Test Plans (ITPs) are included in the Quality Plan and are an
important part of commissioning. Testing procedures which define all levels of
acceptance criteria for all functions involved in the project must be available.
They should clearly identify instruments to be used during testing and calibration and define when the procedure requires review.
Records must be maintained of the date and results of inspection and tests, the
levels of acceptance and the accepting authority.
Adviso y procedures
Inspection and Test Plans, and procedures for their control, must be available
within the Quality Manual for ensuring that components and their installation
meet the product specifications. These apply to the test procedures of various
engineering functions involved in the project:
mechanical testing;
electrical testing;
instrumentation testing;
software testing.
Guidance
The extent of inspection and testing is dependent on various factors including
the material or equipment itself, the specification,safety, operating conditions,
supplier capability. The type of inspection may vary from stage inspection
during manufacture, through functional testing, physical checks of material or
it may be a document review. The full extent of the inspection and testing
required for a particular process plant by the customer is normally specified in
the Quality Plan. If any of the inspection or test results are not in compliance with
it then Sections 4.13 and 4.14 apply and the necessary action must be taken.
It is worth noting that leak testing can be a valuable part of the equipment
inspection procedures. This may be a simple hydrostatic head test or a defined
pressure test to identify small cracks which may not be shown u p by
non-destructive techniques (NDT). This is particularly appropriate for heat
exchangers where the temperature used for the test should also be considered.
Adviso y procedures
Material and equipment inspection may be undertaken either at the supplier's
or manufacturer's premises, or after delivery to site.
(i)
Predelivery inspecfion
the responsibilities for inspection and testing b i the supplier (contractorlsubcontractor)or customer should be defined.
(ii)
Post-delivery inspection
Guidance
The level of receiving inspection and testing will be determined by reference to
the subcontractor's quality performance. If a single product is to be obtained
from two separate subcontractors then, depending on their quality system, it is
acceptable to apply different degrees of inspection. Table 1 (see Section 4.6.2
Evaluation of sub-contractors, page 34) offers guidance as to the required level
of inspection for critical and noncritical purchases.This approach of categorization of subcontractors may also be applied to companies supplying a similar
produd.
Guidance
Where overriding production or installation schedules require the use or incorporation of materials or components for which the quality level has not yet been
established, their use is permitted provided that procedures are implemented
which ensure that the components may readily be located and removed or
rectified should they subsequently prove to be deficient.
Process plants are becoming more complex with the use of exotic materials and
sophisticated control systems. It is therefore essential to check at the earliest
opportunity that the component, material or system for control is 'fit for the
purpose' for which it has been designed. Perhaps the most simple and common
example of the need for positive identification is in the manufacture of vessels.
Today, there exists a very wide selection of chromelnickel alloys for many
different corrosive applications, so the selection of the correct alloy for an
appropriate duty is critical. It is imperative to ensure that any plate or tube
purchased is proved to be what was recommended and subsequently ordered,
prior to fabrication. Once fabrication commences, failure to identlfy correct
materials of construction can lead to increased costs or, at worst, equipmet
failure.
Adviso y procedures
Any material not tested or verified as in Section 4.10.2.1 must not be processed,
manufactured or installed. Any equipment failing tests as specified in Section
4.10.2.1 must not be used if it does not comply with Codes, Standards or
insurance requirements. If plant or material fails to comply for other reasons (for
example, dimensions)it may be installed if agreed on concession with the design
authority at the appropriate level. A signed record of the deficiency and the
concession should be appended to the appropriate documentation -for example, drawing or specification.
A concession procedure (see Section 4.13 Control of nonconforming product,
page 55) should allow for the urgent release of material prior to verification
provided the relevant design and procurement authorities are contacted, risk
assessments carried out and suitable identification and audit trails established
to enable immediate recall.
The essence of Quality Assurance is to build quality into the whole project from
inception to completion. The Quality Plan will include Inspection and Test
Plans (ITPs) stating inspection and testing requirements during construction,
installation and pre-commissioning with reference to relevant International,
British and company Standards and Codes. Functional checks on plant operation should use non-process fluids (for example, water or air) where possible.
Prior to commissioning with non-process fluid the plant should be cleaned.
Chemicalsshould not be introduced to the plant until all inspection and testing
is completed in accordance with the written procedures. The IChemE's book
Process Plant ~ o r n r n i s s i o n i is
n ~a~useful
~
reference.
Adviso y procedures
Due to the complexityof in-process inspection and testing, it is usual to establish
a small group of engineersand other specialists (for example, chemists, insurance
inspectors) who write the Inspection and Test Plans and commissioning procedures. Components common to a number of items of equipment should have
test and record sheets readily available. For example, an electric motor could be
tested for:
explosion protection;
direction and freedom of rotation (hand and power);
stoplstarts;
alarms;
lubrication;
speed of rotation, rpm.
Similarly, test plans should be available for items of equipment such as pumps,
filters, agitators and any other individual item of process equipment. In addition
to testing the installed component and sub-assemblies,other inspection and test
records should include:
verification that the installationis in accordance with drawings and specifications, especially flowsheets, general arrangement drawings and isometrics;
pressure andlor vacuum testing of systems is in accordance with an agreed
pressure testing specification;
recording of service availability, steam, water, compressed air together with
the operating conditions, temperature, pressure, flow, etc.
equipment function - for example, control and safety systems, noise and
vibration;
recording of all results, identifying deficiencies and taking action in accordance with company procedures;
intermediate certification and documentation.
After in-process inspection and testing of the plant, the intermediate certification
and documentation will have been completed.Suitable chemicals may then be
introduced in accordance with the commissioning plan which includes start-up
and operating instructions, prepared as part of the project Quality Plan. It may
be necessary to clean the plant with chemicals compatible with those to be used
in the manufacturing process prior to the introduction of raw materials and/or
feedstock.
Final checks must be carried out on, for example, interlock systems, alarms and
any previously untested flanged connections such as those spaded during
The document which gives evidence that the process plant (product) has passed
all inspection stages satisfactorily and complies with the customer's specification, is generally referred to as the 'handover certificate'.
Inspection and test records are most important for design validation, especially
where it is necessary to demonstrate that the process remains in a validated state,
and this will also assist with future routine maintenance schedules. Records and
documentation required for regulatory bodies must be archived to be available
for future retrieval (seeSection 4.16 Control of quality records, page 64).
With complex process plant installations it is good practice to institute a handover procedure which can be phased to include the different stages of plant
handover. This would not only ensure satisfactory completion of the various
engineering functions, mechanical, chemical, electrical and control, but would
ensure total plant compliance with safety procedures and meet the needs of the
engineering maintenance department.
Handover documentation is frequentlycentred around the original contract (see
Section 4.3 Contract review, page 13) and can sometimes become quite contentious on points of contract detail. If a performance guarantee has been specified
in the original contract then procedures must be written to substantiate that the
terms and conditionsof the process guarantee have been achieved and this must
be verified by representativesfrom the supplier (contractor) and the customer.
Adviso y procedures
Handover procedures should ensure the requirements of the contractor specification have been fully met. Phased handover procedureswill enable the various
stages of commissioning and handover to be agreed systematically and a p
proved by all the nominated departments, engineering, Quality Assurance and
safety. Certain important facets of the project, such as safety as identified during
the Hazop, may require particular examination by safety audit at project completion prior to handover.
Records for compliance with specification, which will include water commissioning and trial batches, will be signed off by the appropriate persons with
authority to release the plant for production.
4.11
The Standard requires not only the control of quantitative measuring devicesbut
also covers test software.
Advisory procedures
Assuming that the suitability of equipment has to be established prior to p r e
curement or issue, the basis of controlis theunique identificationand calibration
(metrological confirmation) of equipment and maintenance of appropriate records. Calibration must be traceable to InternationalStandards.Where this is not
possible the basis for confirmation has to be documented. Items requiring
calibration before use must state that requirement. Provision must be made for
jigslfixtures to be set and checked before use and establish that change has not
occurred during use that would invalidate the settings. Controls for the issue of
4.12
Guidance
Process plant projects are usually 'one-off' installations and need to meet the
requirements of the contract (see Section 4.3 Contract review, page 13).Regular
project reports should be issued during testing and commissioning, highlighting
the current progress and indicating what action is being taken. This should
continue until such time as the plant is fully operational and any action taken
under Section 4.13.1 should be recorded.
Adviso y procedures
Documentation is required to chart the progress of manufacture, installation,
testing and commissioning activities and should show all results including
failures and corrective actions taken. The physical identification of material and
components should also be defined.
Part of the design documentation should include a schedule for future routine
testing of the plant and/or its components.During the installation and commissioning of the complete process plant, or individual component, a procedure
should exist to indicate the test status, which must include marking or tagging
to show that plant is either awaiting inspection, is satisfactory, is quarantined or
is rejected.
The Quality Plan containing the inspection and test results from the construction
and commissioning phases would be placed in a dossier to establish the pedigree
of the plant, and could then be issued to operating and maintenance personnel
or archived as quality records (see Section 4.16 Control of quality records, page
64) for regulatory and design validation purposes.
4.13
4.13.1 General
Guidance
The five phases for the evolution of a process plant are design, procurement,
manufacture, installation and commissioning,and at any stage nonconformance
with the specification may arise.
This section specifies written procedures for identifying and recording nonconformance and specifying the method for evaluation,correction and comrnunication with concerned parties. It also specifies the persons or functions having the
competence and authority to decide how the nonconformity is to be resolved.
As written, this section implies that the product is a physical entity, but it is also
applicable to an activity or service.
Adviso y procedures
(i)
Design
Procedures must specify the methods and controls to be used to record and
correct deficiencies, the manner in which drawings and other documents are to
be marked up and how a 'hold' is put on design and dependent activities to
prevent abortive work. The documents must identify who has the responsibility
and authority to correct technical, commercial and financial deficiencies. The
procedures must also interface with those for the control of design change and
concession (see Sections 4.4.9 Design changes, page 28 and 4.14 Corrective and
preventive action, page 58).
(ii) Procurement
Procurementmay be consideredas the interface with manufacturersand providers of services which implement design or service requirements, defined in the
contracts and specifications.
The assessment of a sub-contractor's capability (see Section 4.6.2 Evaluation of
sub-contractors, page 33) will have reviewed their potential for providing satisfactory goods or services. However, inspections and tests, which may either be
those carried out internally by the subcontractor or externally by the project
organization, may reveal nonconformance. The quality system must quickly
identdy and segregate nonconforming material to prevent inadvertent use. The
sub-contractor's system must record and report deficiencies to appropriate
departments within the organization for resolution and action - for example,
technical matters to design and programme implications to planning.
Procurement activities for the control of nonconformance will interface with
design change control procedures, inspection and verification activities, and
control of quality records. It is essential that they include procedures for control
of concession and purchase order variations.
(iii) Manufacture
Any nonconformance to specification should be identified as soon as practicable
at critical stages in manufacture. Nonconforming material or equipment should
be clearly identified and prevented from further use until corrected and authorized for use (see Section 4.14 Corrective and preventive action, page 58).
Construction materials may be metals or non-metals or a combination of both,
(an example of the latter being rubber-lined mild steel plant). Company and
National Standards must be used for the design of the plant which must include
the inspection and test procedures appropriate for the fabrication. This would
apply to 'in-house' produced items as well as any plant purchased from a
fabricator.
Pressure vessels must be constructed to an appropriate code such as BS 5500.
Procedures should state what class of fabrication is required for the design duty
and the need for independent inspection and test to ensure that the vessel will
comply with Pressure System Regulations. Manufacture also covers the assembly to correct tolerances, surface finish, painting, etc.
(iv) Insfallation
Discovery of an unsatisfactory condition, whether by inspection of incoming
material or during installation, requires well managed and co-ordinated communication of corrective actions to all relevant departments and contractors.
Recording, reviewing and disposing of nonconforming material may be similar
to that employed in the manufacturingprocesses.Segregation of nonconforming
material can be difficult at the installation stage, so identification and recording
of deficiencies needs careful thought and control. They can best be done with a
unique master list under the control of the project engineer or a nominatedsenior
member of the construction team.
(v) Commissioning
Deficienciesdetected during commissioning may well be due to faulty design or
manufacture, incorrect installation or inadequate performance. The comrnissioning procedures should specify how nonconformances are recorded and
communicated to the appropriate function(s).It is extremely important that a
nonconformancewhich may be hazardous to personnelor damaging to the plant
which is identified during commissioning is dealt with urgently. Where this is
impossible, commissioning may have to be restricted or stopped completely.
Procedures for recording and resolving deficiencies must interact with those for
design change control, concession and procurement. It is imperative that the
records refer information and data back to the project review procedure.
The procedures must also provide for identifymg, segregating and disposing of
defective process products to prevent their inadvertent use or entry into mainstream production. These may then be managed through an IS0 9002 quality
system. A useful reference on this topic is Process Plant
Adviso y procedures
This clause offers four options, (a)-(d), for disposition of nonconformance, but
due to the dedicated one-off nature of the plant it is unlikely that option (c),
re-grading for alternative applications, is possible for major items of plant.
Sometimes individual items of equipment, say pumps or valves, may be regraded to a less demandingduty withoutaffecting the overall plant performance.
The options, however, may be used as a basis for resolving disposition at design,
procurement, manufacture, installation or commissioning.
4.14
4.14.1 General
Guidance
This section has two fundamental requirements:
(i) To identify and record causes of nonconformancein equipment or plant or
the quality system, and to specify corrective actions to rechfy the deficiency and
identify actions to prevent their recurrence.
(ii) To implement and record changes to procedures arising from corrective
action.
Adviso y procedures
Where deficiencies in systems, design, equipment, materials or the process plant
itself are detected, those persons and functions responsible and authorized must
investigate and resolve the nonconformity and its cause. Depending on the
nature of the deficiency, the complexityof the solution and the risk involved, the
corrective actions themselves may vary from a simple instruction to a fully
documented procedure or work instruction. The specified action should be
monitored to assess its completion and effectiveness. This may be encompassed
within existing inspection/surveillance instructions or may require a unique
instruction or re-audit of a system. In each case, records must clearly show that
the action has been carried out and that the desired result has been obtained. If
not, the matter must be carried forward and referred to the appropriatefunction
and to Quality Assurance.
The duty to specify and control corrective action will be based on technical
competence, knowledge of the system and organizational authority. The general
principle should be that the functional head of the department where the
nonconformance arose should take responsibility for co-ordinating the corrective action and following it up to effective completion. It has been found useful
to have multidisciplinary corrective action teams comprising the skills and
experience required for solving the particular problem. In matters concerning
design, it may be referred to the designengineer, and the procedurewill interface
with design review, design change and document control. In procurement,
manufacture and installation, responsibility for addressing and completing
corrective action must always lie with functional management. The Quality
Assurance function is normally charged with co-ordinating and monitoring
action for system deficiencies.
The Standard requires the appropriate management level to review nonconformance and the effectiveness of preventive and corrective action.
Method statements for the control of installation and commissioning should
speclfy the data to be gathered, analysis to be conducted - for example,
statistical analysis - and the review bodies responsible for control. These may
be either in the Quality Manual or the Quality Plan.
Corrective action procedures and work instruction should establish:
clear reporting relationships;
individual accountability;
training and resource levels;
records, communication and feedback;
maintenance and revision of company standards;
document control.
4.15
4.15.1 General
Guidance
The requirement applies to all engineering raw materials, work in progress,
fabricated, machined or sub-assembled components, together with fabricated or
proprietary items of process equipment.
4.15.2 Handling
Guidance
This requirementrelates to the handling of material, componentsand equipment
specified in the design, procurement and installation of the process plant. The
handling of plant and equipment is also part of the delivery processand therefore
Section 4.15.6, page 63, should also be referred to.
Adviso y procedures
Handling procedures should ensure that tolerances are maintained, physical
damage is avoided and the ultimate plant integrity is preserved. Different
procedures must be issued depending on the material, sub-componentor item
of equipment being handled. Plant handling procedures will contain specific
reference to safe working practices.
4.15.3 Storage
Guidance
The storage environment needed for the various types of materials, components
and individual items of plant requires an assessment to determine the effect
during storage of temperature, humidity, dust and the potential for physical
damage. Storage areas will vary widely between construction sites, from those
open to inclement weather, to strictly controlled air conditioned rooms. Therefore every application will have to be considered individually and designated
accordingly.
Adviso y procedures
Storage areas should be secure from vandalism and theft. Electrical equipment
may need to be stored under cover, machined parts greased and bearings
lubricated, etc. Process equipment supplied containingchemicals-for example,
refrigeration plant or packed bed dryers - and fragile control equipment and
instrumentation, will require special attention. Storage must take account of the
requirementsof Sections 4.13.1 and 4.14 such that adequate space is availablefor
the separation of nonconforming material and equipment.
The Quality Plan (see Section 4.2 Quality system, page 12) will specify under
what conditions various plant and equipment should be stored. Care must be
exercised to ensure precise demarcation of similar materials - for example,
pipework. All materials and individual items of equipment must be clearly
identified with project tags to meet the requirements of product identification
and traceability (see Section 4.8, page 40). This should enable them to be easily
related to the components on the P&IDs or general arrangement drawings. Any
issue from stores must be clearly identifiable to the original order, as required in
Section 4.7.
4.15.4 Packaging
Guidance
The complexity, value, susceptibility to damage or deterioration of a component
will determine the quality and degree of packaging. Flange faces will require
minimum protection by the applicationof simple plastic covers, whereas vessels
shafts may require the temporary fixing of timbers to prevent distortion during
transit.
Advisory procedures
All materials, sub-assemblies and equipment items must be packed, supported,
strengthened and protected prior to dispatch, to ensure the components' integrity is maintained and damage is prevented during handling, transit and storage.
This requirement must form part of the specificationfor the supply of all material
and equipment. Packaging procedures must be written to ensure that the quality
of the materials and equipment is maintained.
All equipment should be marked in accordance with tagging procedures. Subcontractors should supply equipment and components in accordance with the
numbering specified at the design stage. This will enable components after
inspection on receipt to be segregated to assist with the flow of materials during
installation.
4.15.5 Preservation
Guidance
Major plant items will require adequate protection during transportation. For
example, stainless steel vessels should never be shipped as deck cargo without
adequate protection from sea spray. Similarly, components for critical applications may require special preservation procedures, an example being pipework
for biological processes which may need to be sealed in plastic at the factory to
avoid any form of contamination.
4.15.6 Delivey
Guidance
Most process plant projects are site erected and it is therefore inappropriate to
consider the delivery of the completed plant as an entity. It is the delivery of the
individual components which is the controlling factor. Basic components which
are relatively small can be delivered to site and placed in stores after final
inspection and test either on site or at the sub-contractor(s)works. Larger items
of plant such as distillation columns, large vessels and glass lined equipment, will
have special delivery requirements and these must be considered individually.
necessary escorts. Height and width restrictions along the route must also be
considered and, in certain circumstances, could influence the physical dimensions of large items of plant at the design stage.
When large plant items are delivered to site they will require off-loading and
landing within a structure or on foundations. The delivery of these major plant
items to their final location will require specialist handling skills and will need
cranage on-site. Procedures should exist to ensure that plant is aligned and
installed as per design, before cranes are released.
The timing and co-ordinationof plant and equipment delivery is critical during
the installation phase of the project, and the suppliers must ensure that every
component arrives on time on site according to the project co-ordination
procedure.
Adviso y procedures
For the delivery of plant to site, clear instructions as to the exact location of the
equipment are essential. Therefore, delivery instructions should be explicit and
are usually stated on the purchase order.
Rigging, slings and chains must be available and need to be checked regularly.
A register is required to demonstrate that rigging slings and chains have been
inspected on a periodic basis to comply with safey legislation.
4.16
Guidance
Quality records do not just arise, they have to be planned. Consideration must
be given at design, procurement, inspection, testing, construction,commissioning
and validation stages to ensure the records are established. This may be done
within the overall Quality Plan for the Inspection and Test Plans (ITPs).
Inspection and test records are important for validation. They also provide a
reference against which later performance can be compared. All the inspection
and test results (or the IQ, OQ and PQ documentation- see Section 4.4.8, page
28) must be carefully archived and easily retrieved for the system to be of benefit
(seeSection 4.5.2(c) Document and data approval and issue, page 30). For some
regulatory bodies, it is important to demonstrate document retrieval within
predetermined times.
Quality records will have been maintained as a result of compliance with other
sections within the Standard (seeSection 4.10.5 Inspection and test records, page
51).
Recordsof design drawings, documents or calculationsmay be held on electronic
files or as hard copy. Consideration should be given to the storage of critical
documentationin duplicate at different locations in case of loss due to fire, flood
or theft.
Advisory procedures
A design dossier should be collated with all the approved material certificates,
quality related documentation, letters of conformity and test certificates which
will be given to the customer at handover of the plant. This dossier will establish
the 'pedigree' of the plant and will be used for future plant maintenance and
inspection schedules. It also provides the objective evidence to auditors, third
party assessors and to the customer of compliance with the Quality Assurance
system and product specification.
4.17
Guidance
Audit of the quality system against the requirementsof the Standard is mandatory and will cover quality planning.
into account the importance of each part of the system to ensure that quality is
maintained. This would then be used to construct an annual programme as the
basis for planning the availability of appropriate auditors and to provide documentary evidence of the audit plan.
system. To gain the most benefit from auditing, it must be seen as a tool or
technique for improving and developing the system from experience of its
operation and to keep abreast of changes.
Unfortunately, auditing is too often regarded as a policing and monitoring
procedure. This can be threatening to the managers implementing the system
under scrutiny. Thus, to be effective, auditors need to adopt a positive, helpful
and constructive attitude to audits to demonstrate their willingness to suggest
improvements and to give credit where systems are working well. This is in
addition to their normal role of establishing that the quality system is being
implemented as described in the documented procedures.
Applied in this manner to the procedures outlined in this guide, auditing will
consolidate and develop a sound system aimed at 'getting it right first time' and
a much safer and less stressful commissioning phase will be the reward.
Although not a requirement of IS0 9001, a good audit will also look for:
potential improvements in the quality system;
simplification of procedures without loss of effectiveness;
ways of reducing potential overlap, contradictions or gaps in procedures
interfacing with other departments.
A good auditing procedure should become an unobtrusive and helpful activity
welcomed by managers committed to the principles of Quality Assurance and
Total Quality Management. Implemented effectively, it will increase safety and
reduce risks and costly errors in the most complex projects. It will also result in
increased confidence and morale in the design function and lead to more satisfied
customers, whether internal or external.
4.18
Training
Guidance
Procedures are required to specify the means and responsibility for reviewing
and planning training needs to ensure that the design, procurement, manufacture, construction and commissioning of a process plant project are carried out
by skilled, competent individuals for all activities.
Procedures are required to idenhfy all activities and the level of skill, experience
and knowledge needed to perform them satisfactorilyand to define and provide
the necessary training. Adequate records of such training must be maintained
and documented.
Adviso y procedures
A comprehensive procedure, including job descriptions and performance a p
praisals by direct managers of each employee, has been found to be effective.Job
4.19
Servicing
Guidance
Where proprietary equipment of a specialized design or application is specified
which requiresspecialist skillsto maintain its safety, reliability,performance and
integrity, a maintenance contract with the manufacturer may be specified in the
main contract. Where this is so, the supplier (contractor/subcontractor)must
ensure that the servicing is carried out to specified criteria and procedures.This
will include frequency of servicing and the checks to be made at each service.
Records will be kept of faults found, corrective actions taken and further checks
needed, if any. Equipment which falls into this category may include refrigeration packages, scrubbers, cooling towers, compressors, emergency generators
and water treatment services.
4.20
Statistical techniques
4.20.2 Procedures
Guidance
Apart from the points made in Section 4.20.1, statistical control techniques are
more appropriate to the production output from the process plant, rather than
the activities associated with its design and construction.
Text references
1.
BS 5750 Part 0, IS0 9000,1979, Quality systems: Principles, Concepts and
Applications,Section 0.1 1987 Guide to the selection and use (British Standards
Institution).
2.
CIA, 1987, BS 5750: Guidelines for Use by the Chemical Industry (Chemical
Industries Association, London).
CEFIC, 1991, EN29001,IS0 9001: Guidelines for Use by the Chemical Industry
3.
(CEFIC, Brussels).
4.
BS 5750 Part 1, IS0 9001, 1987, Specification for DesigrdDevelopment,
Production, Installation and Servicing (British Standards Institution).
12. IS0 9000-3: 1991, Quality Management and Quality Assurance Standards
Part 3: Guidelinesfor the applicationof IS0 9001 to the development supply and
maintenance of software.
13. 'TicklT' Guide to Software Quality Management System, Construction and
Certification using IS0 9001/EN 29001/BS 5750 Part 1,1992 (Department of Trade
and Industry). This publication includes IS0 9000-3.
14. Horsley, D.M.C. and Parkinson, J.S., 1990, Process Plant Commissioning
(IChemE, Rugby).
15. IS0 10012: 1992, Quality Assurance Requirements for Measuring Equip
ment, Partl. Identical to BS 5781 Part 1,1992 (British Standards Institution).
16. IS0 2859-1: 1989, BS 6001: Part 1: 1991, Specification for Sampling Plans
Indexed by Acceptable Quality Level (AQL)for Lot-by-Lot Inspection.