Eli Lilly implemented a construction quality assurance (CQA) program to manage quality on a major $400 million capital project in Kinsale, Ireland. The CQA program identified over 10,000 issues during construction, with 78.8% found before handover. This allowed most issues to be resolved before affecting commissioning. As a result, commissioning was completed under budget and 4 months ahead of schedule compared to a similar previous project. The CQA program's early identification and resolution of issues improved quality and reduced rework costs.

1. tce HOUSING & CONSTRUCTION
Assured quality
saves money
In harsh economic
C the world of pharma
URRENT economic difficulties
make it all the more important
times, quality assurance that businesses are efficient and
The pharmaceutical industry is highly
regulated and requires that manufacturers
is all the more productive in their operations, and this is demonstrate that their processes are under
no different in the construction industry
important, say Bruce where there’s a constant dynamic balance
control, capable of consistently producing
quality medicines and above all are validated.
Beck and Jay Lad of cost, schedule and quality. Obviously, In general, the world of pharmaceutical
the desire is always to have optimal manufacturing is precise, heavily scrutinised
performance in all three areas, but often and operates under strict QA/QC (quality
quality is compromised at the expense of assurance/quality control) rules. It can be
cost and schedule. characterised by its ‘batch sheet’ mentality.
In recent years, significant work has In stark contrast, however, pharmaceutical
gone into studying construction quality facility design/construction is an evolving
and specifically, how to reduce rework. and imprecise world. It’s a world where ideas,
Unfortunately, it’s often been difficult to concepts and designs are developed by
gather data and effectively analyse field engineers and scientists, which constructors
quality performance. attempt to bring to reality. Project design
We discussed how to manage construction often starts while the products are still
quality in our article Can we build it? in development and are yet to be fully
published in tce 841 (July 2011). We follow characterised and understood. As a result,
this with a case study, showing how Eli aspects of the facility often evolve and change
Lilly and Company successfully used a during design and construction, leading –
construction quality assurance (CQA) in extreme cases – to a complete redesign
programme to manage a major capital midway through a project.
project in Europe. For a long time, engineers have been trying
to apply the batch sheet mindset of the
manufacturing world to the changing world of
Figure 1: Issue timing and impact assessment engineering and construction, often resulting
in escalating costs as well as large programme
Construction TCCC Commissioning
overruns and delays.
The challenge has been to merge these
& validation two worlds and bring a level of QA/QC
competency to field execution.
Issue timing
Each issue was identified as Eli Lilly
Pre-TCCC or Post-TCCC In 2001, Eli Lilly found itself in an intense
period of capital expansion worldwide.
At the same time the industry was going
through increased regulatory scrutiny of
Issue impact assessment manufacturing practices and validation of
Commissioning impact – Issue would hinder ability to commission/validate new facilities. This resulted in more rigourous
Other impact – Issue would NOT impact commissioning/validation testing and verification of system design,
but other impact on delivery installed equipment and operation, and
the documentation and rigour of testing
requirements increased significantly.
Severity of issue classification Lilly addressed these increased demands
Category 1: Severe issue, requires immediate attention by developing and implementing a robust
Category 2: Significant issue, needs attention before proceeding commissioning/validation programme, which
Category 3: Incomplete or minor repairs/adjustments needed significantly improved cost, time and quality.
Category 4: Change in design required. Evaluate change However, as it improved its programme it
began to realise that field quality issues were
having an adverse effect.
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Therefore, in 2005, Lilly began to examine
the impact of construction quality on the Figure 2: % of issues found post-TCCC that impact on
programme and soon concluded that
construction deficiencies and poor field commissioning
quality management were a significant 120%
hindrance. Each time a construction
issue was found, the company had to 100%
halt commissioning and re-engage the The impact of quality
issues on commissioning
% of issues found post-TCCC
construction team to rectify the issue – 80% were minimal
costing time, money and more importantly
compromising schedule. 60%
As a result, Lilly sought to develop a QA/
QC programme in the field to avoid similar 40%
problems in future.
20% Good
task at hand
In 2007 Eli Lilly committed to build a new 0%
US$400m biotech facility in Kinsale, Ireland 18/12/2008 28/03/2009 06/07/2009 14/10/2009 22/01/2010 02/05/2010 10/8/2010 18/11/2010 26/02/2011
which was critical to its long-term strategy in -20%
biotechnology. With almost US$0.5b at stake,
Lilly was keen to ensure that the facility -40%
was delivered on time, within budget and TCCC (Transfer of Care Custody and Control)
provided a return on invested capital.
From previous experience, the company
recognised that good construction quality • pre-qualification of the contractor’s quality all or the majority of issues identified pre-
was key to ensuring the quality of the programme; TCCC and to track whether any issues could
finished facility and avoiding any negative • implementation of job specific quality impact commissioning and validation.
impact on cost, schedule and knock-on plans; and The team also classified each issue by
effects on the overall performance of • the quality monitoring programme. severity. This classification identified the
the facility post hand-over. As a result, a The CQA team took advantage of the nature of the issue and urgency for resolution
construction quality team was created latest construction field software, tablet PC (see Figure 1).
within the overall construction management and the internet to help implement its CQA
team to implement a construction quality programme. This allowed field inspectors the findings
assurance (CQA) programme for the project. to document, communicate and track issues Lilly recorded 10,990 quality issues during
The primary aim of Lilly’s CQA programme throughout the project in one web-hosted the Kinsale Biotech project, all of which
was to raise the importance of quality and database as opposed to historical approaches were recorded, tracked with a unique
self-inspections to the contractors in order of notebooks, spreadsheets and emails. This identification number and often included a
to prevent deficiencies, minimise defective not only improved the ability to record and digital picture for ease of communication.
work and strive towards a zero critical items track issues, but also provided valuable data These issues ranged from structural errors to
punch list. It was critical that field issues for analysing effectiveness of the overall CQA instruments missing or not properly installed.
were identified early during construction programme. Of the 10,990 issues identified, 78.8% of
and resolved quickly in order to prevent them were identified pre-TCCC, during the
them from surfacing late in the project. As a issues in the field construction phase of the system. This meant
result the CQA team conducted inspections, Each issue identified by a contractor, that 21.2% of issues were identified post-
tracked issues and worked closely with inspector or other member of the TCCC during commissioning. While that was
contractors to assure quality of work and construction management team was given a disappointingly high proportion and raised
timely resolution of issues. a unique identifying number. There were initial concerns over the general effectiveness
several attributes assigned to each issue to of the programme, closer scrutiny showed
CQA programme properly assess and characterise the issue, that only 0.49% of all issues were of severity
Lilly’s CQA programme was a mirror such as description of issue, system the issue level 1 or 2 and identified post-TCCC –
image of its successful contractor safety belonged to, priority of issue, commissioning showing that CQA was actually quite effective
programme. It comprised of three pillars: impacting potential, and contractor in preventing severe issues from impacting
responsibility. commissioning/validation.
Having this type of information in a The majority of the post-TCCC identified
database, accessible from anywhere in issues were severity level 3 and included
Lilly had recognised that the world, gave much better and timely items such as missing tags, labels, insulation
good construction quality information on quality issues and status. and so on.
For the CQA programme to be successful This project had 112 systems which
was key to ensuring the were formally managed and turned
it was crucial that at transfer of care, custody
quality of the finished facility and control (TCCC) of each system (from the over individually from construction to
and avoiding any negative construction team to the commissioning/ commissioning/validation. The percentage
validation team) there were minimal of issues found post-TCCC that impacted
impact on cost, schedule
quality issues that could impact on the commissioning was graphed out (see Figure
and knock-on effects on the commissioning/validation team’s ability to 2) and demonstrates that as systems were
overall operation produced proceed with its work. The intent was to have turned over throughout the project, the
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3. tce HOUSING & CONSTRUCTION
were weekly (and eventually daily) quality
Figure 3: Final project performance comparison review meetings with the contractors to
review issues and make sure they were being
resolved in a timely manner.
Categories 2010 2006
step 6: embrace technology
Facility type Biotech manufacturing Biotech manufacturing
The technology used at Kinsale was extremely
Capital project cost US$400m US$400m valuable in managing the CQA programme.
Project location Kinsale, Ireland Indianopolis, Indiana, US There are a number of technologies available
Defined CQA programme? Yes No on the markets today which are very useful
in recording, tracking and communicating
Commissioning/validation
20 people 70 people quality issues. When selecting technology
peak staff
tools it’s recommended that they should be
Commissioning/validation <4% TIC ~10% TIC user- and field-friendly, use digital cameras
costs (Total installed cost) (Total installed cost) to capture issues easily, capable of extracting
Performance against data for learning, and easily accessible from
Under budget Over budget
budgets anywhere in world via the web.
Total commissioning/
validation duration
7.1 months 11.4 months summary
The Kinsale biotech project was a success
in that it not only came in under budget and
Conclusion: Kinsale facility delivered faster and cheaper!
delivered ahead of schedule, but also the end
users were able to start the processes in a
timely, successful and sustainable manner.
number of issues identified post-TCCC and often requires a fundamental change
decreased steadily, indicating continuous in behaviour. Training must be deliberate, The CQA programme was critical to the
improvement in inspection and construction. reinforced and verified to ensure changes overall success of the project as it allowed
in behaviour are taking place. It’s important early detection of field issues and faster
splitting the cost that the CQA team checks status routinely resolution. This proactive approach to field
Lilly’s CQA programme cost around US$2m, and maintains a positive emphasis. It’s quality resulted in fewer issues impacting
split between labour and software. In addition not negative to find issues, just like it’s not the back end of the project. As a result, the
around US$5m was spent on rework (i.e. 2.2% negative to report an unsafe condition on a commissioning/validation team was able to
of direct cost). Studies by the Construction site. This was a challenge at Kinsale and we focus its attention and efforts on functional
Industry Institute indicates that rework for realise we should have put more emphasis on performance rather than construction rework.
projects of this type can typically run to 4–7% understanding and buy-in up front.
of direct cost, demonstrating that the CQA conclusion
step 2: develop CQA plan for project
programme saved US$4.3–11.2m. Good construction quality is a prerequisite
It’s worth having a structured CQA plan
It’s also worth noting that rework was for successful commissioning/validation.
for the project which defines expectations,
largely addressed and paid for by the This case study shows that a relatively small
process and roles and responsibilities
contractor rather than Lilly; contractors investment upfront (ie 0.5% of total installed
for managing and assuring quality. This
realised that Lilly’s CQA programme meant cost) in construction quality can bring huge
establishes a foundation for the programme
field defects could be identified much earlier benefits at the end of the project and beyond,
and expectations.
in the project, allowing faster resolution and reducing cost/schedule and ultimately
step 3: engage contractors in the process
quicker payment. Lilly realised that issues helping speed products to market.
The more you engage the contractor in the
identified by the CQA programme may not In reality, the true cost of failing to get your
process, the better. They must still own the
have been discovered until much later after facility up and running on time is missing
quality of their work, so engaging them
handover. a launch date for a product, losing a race to
in the programme and creating a positive market or not being able to maximise your
comparing projects atmosphere is important. Reinforce that revenue by not meeting market demand for a
this programme is as much for them as it product.
A comparison between Kinsale and a similar
is for the owner. Key tactics included pre-
biotech facility built in 2006 in Indianapolis, Selecting a good constructor is obviously
work meetings with contractors to review
US, which didn’t use a formal construction very important. However, deciding to
specifications, drawings and approaches.
quality assurance programme showed that implement a CQA programme early on in the
the Kinsale project used less than half the step 4: field inspection and reporting project will have significant benefits in helping
number of people in commissioning and programme you deliver a facility on time, to budget, great
validation, which resulted in significant Field inspection by well-trained and quality, zero defects and accidents, good
savings (see Figure 3). Kinsale came in under knowledgeable experts provided vital operability and maintainability, as well as
budget and completed commissioning and assessment of contractor performance high availability and reliability. Moreover, it
validation four months earlier than the throughout the project and adherence to should help guarantee a return on investment
Indianapolis project. quality commitments. and value for money! tce
step 5: routine management of quality
keys to success issues
Lilly identified several fundamental keys to It was very important to have real-time Bruce Beck (beck_bruce_e@lilly.com) is
success for the Kinsale project: management of quality findings. This corporate director for global facility delivery
step 1: cultural change must be managed included identifying, assigning and resolving with Eli Lilly; Jay Lad (jay.lad@spgl.eu) is
CQA is not natural to many contractors issues. On the Kinsale biotech project there managing director with SPGL
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4. tce PLANT COMMISSIONING & DECOMMISSIONING
Can we build it?
Yes we can...
... but it has to be
I
N TODAY’S economic landscape, there quality and excel at project turn-over. In
is great emphasis on assuring ‘return addition, good operability, cost-effective
top quality and cost on capital invested’ and ‘value for maintenance and the entire ‘asset life’
effective, say Jay Lad money’ particularly in large-scale capital
,
projects. This pressure is especially acute
are becoming common key-performance
indicators for the value of the investment.
and Bruce Beck as for complex capital-intensive projects with Large programme delays, costly over-runs
long lead times in the energy, technology and poor operability/reliability resulting
they examine trends and pharmaceutical market sectors. from poor quality are no longer acceptable in
in construction, the Although companies, governments and today’s marketplace.
investors cautiously continue to commit For many years and with dramatic cost to
key to successful capital, there is more pressure today than our economy, the construction sector has
commissioning and ever, especially from a field-execution been struggling with field-quality issues,
perspective, to mitigate risks, control or resulting in commissioning delays and,
time to market conserve cash, accelerate schedule, manage ultimately, facilities with poor operability
and reliability. This cost, however, could
potentially be reduced significantly if the
industry was to embrace the concept of
Inputs Process/activity Deliverables
’quality assurance‘ that has been used with
Project specs, Develop commissioning Project commissioning great success by other sectors of the economy.
drawings and SOPs master plan and schedule plan and schedule
background
Project specs, drawings System information reports Industry today is generally well served
and SOPs. Vendor info Information reports
commissionability studies from a design/engineering perspective, as
it has many design guides readily available.
Designing quality into a facility and, indeed,
Risk-based assessments (cost the concept of ‘quality by design’ (QbD) has
Assessment reports
and schedule perspective)
become the standard and the norm across
many market sectors. Also, the cultures of
Develop receipt and good engineering practice (GEP) and good
RV, IV and
installation verification forms
construction forms
documentation practice (GDP) are well-
and construction QA forms established concepts across many industries.
Project However, a well-designed facility, with
commissioning plan excellent specification and engineering,
Develop commissioning test
System commissioning
packs, functional checks, has little value if the design is not properly
test packs
FATs and SATs
translated into the construction and start-up
of the facility.
Produce and review Project TOP There are many different delivery
turn-over packs methods for capital projects. However, most
Documentation
approaches tend to involve taking a design
Execution
Field audits and pre- Pre-comm test sheets.
and breaking it down into manageable
commissioning checks HSE checklists packages. The constructor then either
chooses to self-perform these packages, sub-
contract it fully or, most commonly, does a
Commissioning, functional Executed commissioning
checks and SATs test packs combination of both sub-contracting and self-
performing.
One would expect the self-performed
Performance and elements of the project to be of a predictable
Performance data sheets
environmental tests
quality. However, the quality of sub-
contracted elements may vary hugely
Commissioning depending on the selection of the sub-
Final handover documentation completion reports
contractors.
Therefore, the effective selection and
management of sub-contractors is crucial to
Figure 1: Commissioning flow chart the successful outcome of a project.
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the field game Figure 2: Project scaling
Unlike design/engineering companies,
3rd party CQA:
whose focus is on QbD, construction Audits against CQA plan, owner’s CQA programme advisor, conducts field inspections
companies tend to be very cost and time Construction manager/general contractor:
driven and, therefore, their focus is on Executes CQA plan, provides quality leadership for sub-contractors
task completion and safety. Ideally, field Contractor:
Executes contract, QA self-inspection
safety and quality should be combined to
deliver projects with zero accidents and Project total direct cost **
zero defects. Indeed, many construction
>$150m
companies do not have a quality manual/
programme and often fail to see the intrinsic $100–$150m
link between quality and safety. $75–$100m
At the outset of a project the appropriate $50–$75m
level of quality must be determined for
$35–$50m
every phase. This is usually established
for the engineering phase. However, it is $25–$35m
often overlooked for the construction and $15–$25m
commissioning phases, which are probably
$10-$15m
the two most critical phases that impact
operability, availability, reliability and $5–$10m
maintainability of a facility. <$5m
A good constructor should normally
Risk = FN {project complexity + contractor quality experience}
have a commissioning plan developed at
the pre-construction stage. The objective 1 2 3 4 5 6 7 8 9 10
being that the most critical and hazardous
parts of the project are fully mapped out (Identify values for project complexity and contractor quality experience, and add together)
and costed, even before the construction
has started (see Figure 1 for an approach to Project complexity (examples) Contractor quality experience
commissioning). Parking lot, landscaping 1 Industry leader/ISO 9000 certified 1
However, a well-planned commissioning
Minimal building construction,
programme, with excellent protocols 2 Projects with alliance contractors 2
installing package equipment
and check sheets, is of little value if the
construction of the overall facility is of Warehouse with temperature control,
3 Projects without alliance contractors 3
a poor quality and littered with defects. laboratory, administration facilities
Therefore, the overall commissioning effort Medium-sized process facility, non- Projects with limited owner
4 4
will ultimately prove to be more dangerous, regulated industry experienced contractors
troublesome and costly. Large scale, complex, regulated
It is clear from the above that, at the process facility (eg pharmaceutical, 5 No previous owner experience 5
pre-construction stage, the approach to biotech, nuclear etc)
construction quality and commissioning
should be fully established in a construction
** Project total direct cost only includes shell, building and process equipment
quality and commissioning plan. The level
of quality/checking to be applied to the
project should be clearly laid out and fully
understood by all parties.
quality exist after contractual obligations end. This
Establishing a ‘culture of quality’ within situation is compounded by the fact that the
an organisation can be quite cumbersome implementation of quality in construction
“
because it requires a complete turnaround requires the selection of the appropriate sub-
in corporate culture and management contractors who would commit to the quality
process and develop a true quality attitude.
establishing approach. It’s also a slow and gradual
process requiring substantial investment Therefore, depending on the size/
a ‘culture of and commitment that may not always complexity of the project, a logical solution
quality’ within an make commercial sense in the construction
industry for one major reason: ‘organisation
to this challenge would be to have the
construction quality function managed by
organisation can be stability’
. a third party. This should be one who really
understands the purpose of the facility, its
quite cumbersome The construction industry has a high
number of collapses, especially during specific operational/maintenance needs and
because it requires a a downturn in the economy. Thus, can bring the appropriate level of quality to
the construction phase (see Figure 2).
complete turnaround commitment towards quality strategies
and policies that may take several years to Is it the architect/engineer or would it make
in corporate culture
and management
“ provide ‘pay-offs’ may be perceived as futile
or a misdirection of resources. As compared
with the head office, the construction site
more sense to have a commissioning firm
work closely with the construction company
to properly integrate quality into construction,
approach is transitory, where teams are specially and leverage this into commissioning to
formed for a project and which may cease to reduce ‘time to market’?
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6. tce PLANT COMMISSIONING & DECOMMISSIONING
A commissioning firm that understands
quality and its application in the field as
Pre-constructability study Design Design QA/QC
well as commissioning requirements may
– Design audits
be ideally placed to take on the role of – Commissioning plan
‘construction quality assurance’ (CQA) – User requirements spec (URSs)
manager. If executed properly, not only can – Risk assessment and criticality
analysis
they carry out this role in a cost-effective
– Traceability of changes
and independent manner, but also add great
Procurement GEP documentation
value to both the constructor and the owner. requirements from vendors/
So how can a commissioning firm deliver suppliers
the right quality to the construction/
commissioning activities in the field? This Construction Manufacture
Construction QA/QC Factory appearance tests (FATs)
can be achieved by implementing a CQA
– Risk assessment and criticality
programme, based on the principles of GEP analysis
and GDP to suit construction as outlined – Sub-contractor assessments
below. – Audits for AFC and in the field
Installation Site acceptance tests (SATs)
– Establishment of appropriate
CQA programme field testing procedures
– Traceability and control of field
At the pre-construction stage of a project, a changes
good construction manager will normally – Use of appropriate
construction forms
prepare a construction quality plan (CQP), – Turn-over package (TOP)
attempting to document the key steps definition and organisation
Mechanical testing
necessary to deliver a building/facility that is – Training of key personnel and
contractor staff
fit for its intended purpose. However, a plan
is simply just a plan and, unless it is part of
an overall integrated field-quality assurance Pre-commissioning
programme, it often proves to be ineffective.
Quality by inspection is limited and unless Integrated construction,
an integrated approach is adopted, success commissioning and
Commissioning
is a probability rather than a certainty! qualification
A CQA programme should aim to ‘Handover of a fully
commissioning and qualified
apply quality concepts and practices facility’
to the construction activities to ensure Performance trials
that the facility is delivered on time, as
specified, defect free and in an operable
state. One of the primary objectives of the In operation
CQA programme should be to raise the
importance of quality and self-inspection/
testing to the constructor/sub-contractors
in order to prevent deficiencies, minimise Figure 3: Approach to project quality
defective work and strive towards a zero
critical-items punch list. However, the
overall responsibility for the construction the outcome is a trouble-free commissioning/ is significant because critical systems, or
quality should never be removed from the start-up, ensuring a reduced ’time to market higher-risk systems, require a higher level of
constructor/sub-contractor. and, ultimately, a return on capital invested documentation, field inspections and testing.
A good CQA programme should allow and value for money! However, it is just as important to identify
owners to use contractors with varying levels The CQA programme should form the and assess the risks to the project from a
of field-quality expertise, yet be assured that basis for integrating construction with field-execution perspective. Therefore, at the
commissioning, the objective being to reduce pre-construction stage the risk assessments
“
cost and time to market through a number should also be carried out from a field
of critical steps as identified below (see perspective, identifying/assessing the
understanding the Figure 3): criticality and interdependencies of systems,
not just from a quality perspective, but also
gaps/deficiencies of step 1. risk assessment and from a commissioning and schedule-impact
the key contractors criticality analysis perspective. This should apply to all systems
At the start of a project, it is important to and be carried out by the CQA manager,
early in the project identify and understand critical aspects of the constructor and the client. A risk assessment
and implementing the project that will impact schedule and cost. that is executed from both a quality and
Risk analysis is often carried out at the schedule perspective will allow the field team
appropriate corrective design phase of a project, by the engineers to identify and prioritise quality/schedule-
actions will be crucial
to the overall success
“ and owners, usually from a design/
engineering perspective. The result
normally captures the client’s expectations
critical aspects of the project.
step 2. sub-contractor assessments
of the project by classifying systems into critical-impact Once the key systems in the field have been
systems and non-critical systems. This identified that will significantly impact
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PLANT COMMISSIONING & DECOMMISSIONING tce
schedule/cost, it is essential to audit the Figure 4: Construction quality modelled
contractors responsible for these systems, on safety programme
in order to ensure that they have the
appropriate quality systems, commissioning
plans, method statements and check sheets Safety Quality
to prevent deficiencies and minimise programme programme
defective work. Understanding the gaps/ Contractor safety qualified Contractor quality qualified
ZERO
deficiencies of the key contractors early Safety assessment Quality assessment
accidents and
in the project and implementing the Job specific safety plan Job specific quality plan
appropriate corrective actions will be crucial defects
Safety procedures Quality procedures
to the overall success of the project. Safety training Quality training
step 3. audits for AFC (approved Safety monitoring Quality monitoring
for construction) drawings, field
inspections and reporting
Compliance audits are normally carried changes in the field than in the design phase. construction personnel and sub-contracting
out at the design phase of a project, by the Therefore, traceability and control of field staff directly involved in completing
engineers and owners, usually from a GEP changes should be a high priority for the documentation for project TOPs should be
perspective. The result normally captures a overall project team, because field changes trained, as a minimum, in GDP as well as
lot of potential issues, largely from a safety, may compromise commissionability/ relevant standard operating procedures and
regulatory, operability and maintainability operability, safety, quality, schedule and field procedures established for the project.
perspective. However, often little or no costs. summary
auditing is carried out from a construction/ The CQA manager should ensure that A good CQA programme should facilitate
field-execution perspective. field changes are properly assessed from proper construction turn-over and ensure
The CQA manager should perform field a safety, commissionability/operability, that systems are ready for commissioning.
audits, focused on high-risk/critical systems quality, schedule and cost perspective. He/ Ultimately, a facility with good construction
that have been identified during the risk and she should also ensure that the field changes quality and minimal defects is more likely
criticality analysis. The primary objective are recorded, properly documented, dated, to have a smooth and trouble-free transition
of the field audits should be to highlight assigned accountability, audited, signed and into the commissioning/start-up phase of
construction-quality issues that may impact properly filed. ‘Red Flag’ items should be the project.
start-up/commissioning and hence the prioritised for action. It is also important to ensure that the CQA
overall project schedule. The field auditing programme is not confused with the field-
should be supported by a formal process to step 6. use of appropriate
safety programme. In fact, both programmes
record, manage and resolve issues. construction forms
should run parallel and mirror each
Ideally, the CQA manager should also All check forms to be used for system other, aiming to deliver a facility with zero
perform compliance audits on ’approved fabrication, installation and testing should accidents and zero defects (see Figure 4).
for construction‘ documentation prior be in compliance with GEP requirements.
to the start of work as well as review bid The forms should also be checked for conclusion
packages to assure that the requirements suitability and contents because they may be The selection of a good constructor is
of the owner are included and delivered. used as leveraged data to the commissioning obviously very important. However,
This is applicable to both vendors and sub- phase, thereby eliminating duplication of selecting a third party to perform CQA early
contractors. Regular meetings should be effort. on in the project will have a very significant
held with vendors/sub-contractors in order impact on the project’s outcome. A clear
to ensure that specifications are understood
step 7. turn-over package (TOP)
commissioning strategy, underpinned with
and appropriate procedures are in place. definition and organisation
a good CQA programme, established at
The CQA manager should develop the turn- the pre-construction stage of the project,
step 4. establishment of over package (TOP) procedure, ideally at the should help translate good engineering
appropriate field procedures pre-construction stage of the project. This design into field execution/construction
The CQA manager should identify should be discussed and agreed with the and help alleviate many of the problems
and establish appropriate field-testing constructor and sub-contractors because encountered at the back end of a project. In
procedures necessary to execute the they will, ultimately, be responsible for the final analysis, especially from an owner/
project. The field-testing procedures should assembling the TOPs. The CQA manager investor perspective: “A successful project is
include inspection plans, commissioning should audit the development of the TOPs where a facility reaches optimal operation in
protocols, test sheets, method statements, and conduct a final review at the hand- a safe manner and in the shortest possible
punch lists as well as procedures governing over stage. This should guarantee a high- timeframe, achieving high availability and
documentation format, storage and quality package, which should include all reliability during the first-cycle operation,
distribution. required up-to-date documentation from maximising cash flow through the first-cycle
vendors, engineering, construction activities, operation!” tce
step 5. traceability and control procurements etc.
of field changes
During the design/engineering phase, step 8. training of key personnel Jay Lad (jay.lad@spgl.eu) is managing
design changes are usually managed and and contractor staff director of SPGL, formerly Skanska
controlled extremely closely. However, the The quality culture of ‘right first time’ Pharmaceutical Group, and Bruce Beck
management and control of field changes should be developed within the project (beck_bruce_e@lilly.com) is director (global
is usually overlooked. Often there are more team through a training programme. All key facility delivery) of Eli Lilly and Company
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