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In harsh economic times, quality assurance is all the more important, say Bruce Beck and Jay Lad

the world of pharmaThe pharmaceutical industry is highly regulated and requires that manufacturers demonstrate that their processes are under control, capable of consistently producing quality medicines and above all are validated. In general, the world of pharmaceutical manufacturing is precise, heavily scrutinised and operates under strict QA/QC (quality assurance/quality control) rules. It can be characterised by its ‘batch sheet’ mentality.

In stark contrast, however, pharmaceutical facility design/construction is an evolving and imprecise world. It’s a world where ideas, concepts and designs are developed by engineers and scientists, which constructors attempt to bring to reality. Project design often starts while the products are still in development and are yet to be fully characterised and understood. As a result, aspects of the facility often evolve and change during design and construction, leading – in extreme cases – to a complete redesign midway through a project.

For a long time, engineers have been trying to apply the batch sheet mindset of the manufacturing world to the changing world of engineering and construction, often resulting in escalating costs as well as large programme overruns and delays.

The challenge has been to merge these two worlds and bring a level of QA/QC competency to field execution.

Eli LillyIn 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 manufacturing practices and validation of new facilities. This resulted in more rigourous testing and verification of system design, installed equipment and operation, and the documentation and rigour of testing requirements increased significantly.

Lilly addressed these increased demands by developing and implementing a robust commissioning/validation programme, which significantly improved cost, time and quality. However, as it improved its programme it began to realise that field quality issues were having an adverse effect.

CURRENT economic difficulties make it all the more important that businesses are efficient and

productive in their operations, and this is no different in the construction industry where there’s a constant dynamic balance of cost, schedule and quality. Obviously, the desire is always to have optimal performance in all three areas, but often quality is compromised at the expense of cost and schedule. In recent years, significant work has gone into studying construction quality and specifically, how to reduce rework. Unfortunately, it’s often been difficult to gather data and effectively analyse field quality performance.

We discussed how to manage construction quality in our article Can we build it? published in tce 841 (July 2011). We follow this with a case study, showing how Eli Lilly and Company successfully used a construction quality assurance (CQA) programme to manage a major capital project in Europe.

Assured quality saves money

Figure 1: Issue timing and impact assessment

Severity of issue classificationCategory 1: Severe issue, requires immediate attention

Category 2: Significant issue, needs attention before proceedingCategory 3: Incomplete or minor repairs/adjustments needed

Category 4: Change in design required. Evaluate change

Issue impact assessmentCommissioning impact – Issue would hinder ability to commission/validate

Other impact – Issue would NOT impact commissioning/validation but other impact on delivery

Issue timingEach issue was identified as

Pre-TCCC or Post-TCCC

TCCCConstruction Commissioning& validation

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Figure 2: % of issues found post-TCCC that impact on commissioning

Therefore, in 2005, Lilly began to examine the impact of construction quality on the programme and soon concluded that construction deficiencies and poor field quality management were a significant hindrance. Each time a construction issue was found, the company had to halt commissioning and re-engage the construction team to rectify the issue – costing time, money and more importantly compromising schedule. As a result, Lilly sought to develop a QA/QC programme in the field to avoid similar problems in future.

task at handIn 2007 Eli Lilly committed to build a new US$400m biotech facility in Kinsale, Ireland which was critical to its long-term strategy in biotechnology. With almost US$0.5b at stake, Lilly was keen to ensure that the facility was delivered on time, within budget and provided a return on invested capital. From previous experience, the company recognised that good construction quality was key to ensuring the quality of the finished facility and avoiding any negative impact on cost, schedule and knock-on effects on the overall performance of the facility post hand-over. As a result, a construction quality team was created within the overall construction management team to implement a construction quality assurance (CQA) programme for the project. The primary aim of Lilly’s CQA programme was to raise the importance of quality and self-inspections to the contractors in order to prevent deficiencies, minimise defective work and strive towards a zero critical items punch list. It was critical that field issues were identified early during construction and resolved quickly in order to prevent them from surfacing late in the project. As a result the CQA team conducted inspections, tracked issues and worked closely with contractors to assure quality of work and timely resolution of issues.

CQA programmeLilly’s CQA programme was a mirror image of its successful contractor safety programme. It comprised of three pillars:

• pre-qualification of the contractor’s quality programme; • implementation of job specific quality plans; and • the quality monitoring programme. The CQA team took advantage of the latest construction field software, tablet PC and the internet to help implement its CQA programme. This allowed field inspectors to document, communicate and track issues throughout the project in one web-hosted database as opposed to historical approaches of notebooks, spreadsheets and emails. This not only improved the ability to record and track issues, but also provided valuable data for analysing effectiveness of the overall CQA programme.

issues in the fieldEach issue identified by a contractor, inspector or other member of the construction management team was given a unique identifying number. There were several attributes assigned to each issue to properly assess and characterise the issue, such as description of issue, system the issue belonged to, priority of issue, commissioning impacting potential, and contractor responsibility. Having this type of information in a database, accessible from anywhere in the world, gave much better and timely information on quality issues and status. For the CQA programme to be successful it was crucial that at transfer of care, custody and control (TCCC) of each system (from the construction team to the commissioning/validation team) there were minimal quality issues that could impact on the commissioning/validation team’s ability to proceed with its work. The intent was to have

all or the majority of issues identified pre-TCCC and to track whether any issues could impact commissioning and validation. The team also classified each issue by severity. This classification identified the nature of the issue and urgency for resolution (see Figure 1).

the findingsLilly recorded 10,990 quality issues during the Kinsale Biotech project, all of which were recorded, tracked with a unique identification number and often included a digital picture for ease of communication. These issues ranged from structural errors to instruments missing or not properly installed. Of the 10,990 issues identified, 78.8% of them were identified pre-TCCC, during the construction phase of the system. This meant that 21.2% of issues were identified post-TCCC during commissioning. While that was a disappointingly high proportion and raised initial concerns over the general effectiveness of the programme, closer scrutiny showed that only 0.49% of all issues were of severity level 1 or 2 and identified post-TCCC – showing that CQA was actually quite effective in preventing severe issues from impacting commissioning/validation. The majority of the post-TCCC identified issues were severity level 3 and included items such as missing tags, labels, insulation and so on. This project had 112 systems which were formally managed and turned over individually from construction to commissioning/validation. The percentage of issues found post-TCCC that impacted commissioning was graphed out (see Figure 2) and demonstrates that as systems were turned over throughout the project, the

The impact of quality issues on commissioning

were minimal

120%

100%

80%

60%

40%

20%

0%

-20%

-40%

% o

f is

sues

fo

und

po

st-T

CC

C

TCCC (Transfer of Care Custody and Control)

Good

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

Lilly had recognised that good construction quality was key to ensuring the quality of the finished facility and avoiding any negative impact on cost, schedule and knock-on effects on the overall operation produced

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number of issues identified post-TCCC decreased steadily, indicating continuous improvement in inspection and construction.

splitting the costLilly’s CQA programme cost around US$2m, split between labour and software. In addition around US$5m was spent on rework (i.e. 2.2% of direct cost). Studies by the Construction Industry Institute indicates that rework for projects of this type can typically run to 4–7% of direct cost, demonstrating that the CQA programme saved US$4.3–11.2m. It’s also worth noting that rework was largely addressed and paid for by the contractor rather than Lilly; contractors realised that Lilly’s CQA programme meant field defects could be identified much earlier in the project, allowing faster resolution and quicker payment. Lilly realised that issues identified by the CQA programme may not have been discovered until much later after handover.

comparing projectsA comparison between Kinsale and a similar biotech facility built in 2006 in Indianapolis, US, which didn’t use a formal construction quality assurance programme showed that the Kinsale project used less than half the number of people in commissioning and validation, which resulted in significant savings (see Figure 3). Kinsale came in under budget and completed commissioning and validation four months earlier than the Indianapolis project.

keys to successLilly identified several fundamental keys to success for the Kinsale project:step 1: cultural change must be managed CQA is not natural to many contractors

and often requires a fundamental change in behaviour. Training must be deliberate, reinforced and verified to ensure changes in behaviour are taking place. It’s important that the CQA team checks status routinely and maintains a positive emphasis. It’s not negative to find issues, just like it’s not negative to report an unsafe condition on a site. This was a challenge at Kinsale and we realise we should have put more emphasis on understanding and buy-in up front.

step 2: develop CQA plan for projectIt’s worth having a structured CQA plan for the project which defines expectations, process and roles and responsibilities for managing and assuring quality. This establishes a foundation for the programme and expectations.

step 3: engage contractors in the processThe more you engage the contractor in the process, the better. They must still own the quality of their work, so engaging them in the programme and creating a positive atmosphere is important. Reinforce that this programme is as much for them as it is for the owner. Key tactics included pre-work meetings with contractors to review specifications, drawings and approaches.

step 4: field inspection and reporting programmeField inspection by well-trained and knowledgeable experts provided vital assessment of contractor performance throughout the project and adherence to quality commitments.

step 5: routine management of quality issues It was very important to have real-time management of quality findings. This included identifying, assigning and resolving issues. On the Kinsale biotech project there

were weekly (and eventually daily) quality review meetings with the contractors to review issues and make sure they were being resolved in a timely manner.

step 6: embrace technology The technology used at Kinsale was extremely valuable in managing the CQA programme. There are a number of technologies available on the markets today which are very useful in recording, tracking and communicating quality issues. When selecting technology tools it’s recommended that they should be user- and field-friendly, use digital cameras to capture issues easily, capable of extracting data for learning, and easily accessible from anywhere in world via the web.

summaryThe Kinsale biotech project was a success in that it not only came in under budget and delivered ahead of schedule, but also the end users were able to start the processes in a timely, successful and sustainable manner. The CQA programme was critical to the overall success of the project as it allowed early detection of field issues and faster resolution. This proactive approach to field quality resulted in fewer issues impacting the back end of the project. As a result, the commissioning/validation team was able to focus its attention and efforts on functional performance rather than construction rework.

conclusion Good construction quality is a prerequisite for successful commissioning/validation. This case study shows that a relatively small investment upfront (ie 0.5% of total installed cost) in construction quality can bring huge benefits at the end of the project and beyond, reducing cost/schedule and ultimately helping speed products to market. In reality, the true cost of failing to get your facility up and running on time is missing a launch date for a product, losing a race to market or not being able to maximise your revenue by not meeting market demand for a product. Selecting a good constructor is obviously very important. However, deciding to implement a CQA programme early on in the project will have significant benefits in helping you deliver a facility on time, to budget, great quality, zero defects and accidents, good operability and maintainability, as well as high availability and reliability. Moreover, it should help guarantee a return on investment and value for money! tce

Bruce Beck (beck_bruce_e@lilly.com) is corporate director for global facility delivery with Eli Lilly; Jay Lad (jay.lad@spgl.eu) is managing director with SPGL

Figure 3: Final project performance comparison

Conclusion: Kinsale facility delivered faster and cheaper!

Categories 2010 2006

Facility type Biotech manufacturing Biotech manufacturing

Capital project cost US$400m US$400m

Project location Kinsale, Ireland Indianopolis, Indiana, US

Defined CQA programme? Yes No

Commissioning/validation peak staff

20 people 70 people

Commissioning/validation costs

<4% TIC (Total installed cost)

~10% TIC(Total installed cost)

Performance against budgets

Under budget Over budget

Total commissioning/validation duration

7.1 months 11.4 months

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... but it has to be top quality and cost effective, say Jay Lad and Bruce Beck as they examine trends in construction, the key to successful commissioning and time to market

IN TODAY’S economic landscape, there is great emphasis on assuring ‘return on capital invested’ and ‘value for

money’, particularly in large-scale capital projects. This pressure is especially acute for complex capital-intensive projects with long lead times in the energy, technology and pharmaceutical market sectors. Although companies, governments and investors cautiously continue to commit capital, there is more pressure today than ever, especially from a field-execution perspective, to mitigate risks, control or conserve cash, accelerate schedule, manage

quality and excel at project turn-over. In addition, good operability, cost-effective maintenance and the entire ‘asset life’ are becoming common key-performance indicators for the value of the investment. Large programme delays, costly over-runs and poor operability/reliability resulting from poor quality are no longer acceptable in today’s marketplace. For many years and with dramatic cost to our economy, the construction sector has been struggling with field-quality issues, resulting in commissioning delays and, ultimately, facilities with poor operability and reliability. This cost, however, could potentially be reduced significantly if the industry was to embrace the concept of ’quality assurance‘ that has been used with great success by other sectors of the economy.

backgroundIndustry today is generally well served from a design/engineering perspective, as it has many design guides readily available. Designing quality into a facility and, indeed, the concept of ‘quality by design’ (QbD) has become the standard and the norm across many market sectors. Also, the cultures of good engineering practice (GEP) and good documentation practice (GDP) are well-established concepts across many industries. However, a well-designed facility, with excellent specification and engineering, has little value if the design is not properly translated into the construction and start-up of the facility. There are many different delivery methods for capital projects. However, most approaches tend to involve taking a design and breaking it down into manageable packages. The constructor then either chooses to self-perform these packages, sub-contract it fully or, most commonly, does a combination of both sub-contracting and self-performing. One would expect the self-performed elements of the project to be of a predictable quality. However, the quality of sub-contracted elements may vary hugely depending on the selection of the sub-contractors. Therefore, the effective selection and management of sub-contractors is crucial to the successful outcome of a project.

Can we build it? Yes we can...

Figure 1: Commissioning flow chart

Inputs Process/activity Deliverables

Documentation

Execution

Project specs, drawings and SOPs

Develop commissioning master plan and schedule

System information reports commissionability studies

Risk-based assessments (cost and schedule perspective)

Develop receipt and installation verification forms and construction QA forms

Develop commissioning test packs, functional checks,

FATs and SATs

Produce and review turn-over packs

Field audits and pre-commissioning checks

Commissioning, functional checks and SATs

Performance and environmental tests

Final handover documentation

Project commissioning plan and schedule

Information reports

Assessment reports

RV, IV and construction forms

System commissioning test packs

Project TOP

Pre-comm test sheets. HSE checklists

Executed commissioning test packs

Performance data sheets

Commissioning completion reports

Project specs, drawings and SOPs. Vendor info

Project commissioning plan

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the field gameUnlike design/engineering companies, whose focus is on QbD, construction companies tend to be very cost and time driven and, therefore, their focus is on task completion and safety. Ideally, field safety and quality should be combined to deliver projects with zero accidents and zero defects. Indeed, many construction companies do not have a quality manual/programme and often fail to see the intrinsic link between quality and safety. At the outset of a project the appropriate level of quality must be determined for every phase. This is usually established for the engineering phase. However, it is often overlooked for the construction and commissioning phases, which are probably the two most critical phases that impact operability, availability, reliability and maintainability of a facility. A good constructor should normally have a commissioning plan developed at the pre-construction stage. The objective being that the most critical and hazardous parts of the project are fully mapped out and costed, even before the construction has started (see Figure 1 for an approach to commissioning). However, a well-planned commissioning programme, with excellent protocols and check sheets, is of little value if the construction of the overall facility is of a poor quality and littered with defects. Therefore, the overall commissioning effort will ultimately prove to be more dangerous, troublesome and costly. It is clear from the above that, at the pre-construction stage, the approach to construction quality and commissioning should be fully established in a construction 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.

“

“ establishing a ‘culture of quality’ within an organisation can be quite cumbersome because it requires a complete turnaround in corporate culture and management approach

qualityEstablishing a ‘culture of quality’ within an organisation can be quite cumbersome because it requires a complete turnaround in corporate culture and management approach. It’s also a slow and gradual process requiring substantial investment and commitment that may not always make commercial sense in the construction industry for one major reason: ‘organisation stability’. The construction industry has a high number of collapses, especially during a downturn in the economy. Thus, commitment towards quality strategies and policies that may take several years to provide ‘pay-offs’ may be perceived as futile or a misdirection of resources. As compared with the head office, the construction site is transitory, where teams are specially formed for a project and which may cease to

Figure 2: Project scaling

exist after contractual obligations end. This situation is compounded by the fact that the implementation of quality in construction requires the selection of the appropriate sub-contractors who would commit to the quality process and develop a true quality attitude.

Therefore, depending on the size/complexity of the project, a logical solution to this challenge would be to have the construction quality function managed by a third party. This should be one who really understands the purpose of the facility, its specific operational/maintenance needs and can bring the appropriate level of quality to the construction phase (see Figure 2).

Is it the architect/engineer or would it make more sense to have a commissioning firm work closely with the construction company to properly integrate quality into construction, and leverage this into commissioning to reduce ‘time to market’?

3rd party CQA: Audits against CQA plan, owner’s CQA programme advisor, conducts field inspectionsConstruction manager/general contractor: Executes CQA plan, provides quality leadership for sub-contractorsContractor: Executes contract, QA self-inspection

>$150m

$100–$150m

$75–$100m

$50–$75m

$35–$50m

$25–$35m

$15–$25m

$10-$15m

$5–$10m

<$5m

Risk = FN {project complexity + contractor quality experience}

1 2 3 4 5 6 7 8 9 10

Project complexity (examples)

Parking lot, landscaping 1

Minimal building construction, installing package equipment

2

Warehouse with temperature control, laboratory, administration facilities

3

Medium-sized process facility, non-regulated industry

4

Large scale, complex, regulated process facility (eg pharmaceutical, biotech, nuclear etc)

5

Contractor quality experience

Industry leader/ISO 9000 certified 1

Projects with alliance contractors 2

Projects without alliance contractors 3

Projects with limited owner experienced contractors

4

No previous owner experience 5

(Identify values for project complexity and contractor quality experience, and add together)

** Project total direct cost only includes shell, building and process equipment

Project total direct cost **

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A commissioning firm that understands quality and its application in the field as well as commissioning requirements may be ideally placed to take on the role of ‘construction quality assurance’ (CQA) manager. If executed properly, not only can they carry out this role in a cost-effective and independent manner, but also add great value to both the constructor and the owner. So how can a commissioning firm deliver the right quality to the construction/commissioning activities in the field? This can be achieved by implementing a CQA programme, based on the principles of GEP and GDP to suit construction as outlined below.

CQA programmeAt the pre-construction stage of a project, a good construction manager will normally prepare a construction quality plan (CQP), attempting to document the key steps necessary to deliver a building/facility that is 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 programme, it often proves to be ineffective. Quality by inspection is limited and unless an integrated approach is adopted, success is a probability rather than a certainty! A CQA programme should aim to apply quality concepts and practices to the construction activities to ensure that the facility is delivered on time, as specified, defect free and in an operable state. One of the primary objectives of the 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 defective work and strive towards a zero critical-items punch list. However, the overall responsibility for the construction quality should never be removed from the constructor/sub-contractor. A good CQA programme should allow owners to use contractors with varying levels of field-quality expertise, yet be assured that

the outcome is a trouble-free commissioning/start-up, ensuring a reduced ’time to market and, ultimately, a return on capital invested and value for money! The CQA programme should form the basis for integrating construction with commissioning, the objective being to reduce cost and time to market through a number of critical steps as identified below (see Figure 3):

step 1. risk assessment and criticality analysisAt the start of a project, it is important to identify and understand critical aspects of the project that will impact schedule and cost. Risk analysis is often carried out at the design phase of a project, by the engineers and owners, usually from a design/engineering perspective. The result normally captures the client’s expectations by classifying systems into critical-impact systems and non-critical systems. This

Figure 3: Approach to project quality

Mechanical testing

Pre-commissioning

Commissioning

Performance trials

In operation

Procurement

Manufacture

Installation

Construction

Design QA/QC– Design audits– Commissioning plan– User requirements spec (URSs)

– Risk assessment and criticality analysis– Traceability of changes

GEP documentation requirements from vendors/suppliers

Factory appearance tests (FATs)

Site acceptance tests (SATs)

Construction QA/QC– Risk assessment and criticality analysis– Sub-contractor assessments– Audits for AFC and in the field– Establishment of appropriate field testing procedures– Traceability and control of field changes – Use of appropriate construction forms– Turn-over package (TOP) definition and organisation– Training of key personnel and contractor staff

Integrated construction, commissioning and qualification‘Handover of a fully commissioning and qualified facility’

Pre-constructability study Design

is significant because critical systems, or higher-risk systems, require a higher level of documentation, field inspections and testing.

However, it is just as important to identify and assess the risks to the project from a field-execution perspective. Therefore, at the pre-construction stage the risk assessments should also be carried out from a field perspective, identifying/assessing the criticality and interdependencies of systems, not just from a quality perspective, but also from a commissioning and schedule-impact perspective. This should apply to all systems and be carried out by the CQA manager, constructor and the client. A risk assessment that is executed from both a quality and schedule perspective will allow the field team to identify and prioritise quality/schedule-critical aspects of the project.

step 2. sub-contractor assessmentsOnce the key systems in the field have been identified that will significantly impact

“

“ understanding the gaps/deficiencies of the key contractors early in the project and implementing the appropriate corrective actions will be crucial to the overall success of the project

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schedule/cost, it is essential to audit the contractors responsible for these systems, in order to ensure that they have the appropriate quality systems, commissioning plans, method statements and check sheets to prevent deficiencies and minimise defective work. Understanding the gaps/deficiencies of the key contractors early in the project and implementing the appropriate corrective actions will be crucial to the overall success of the project.

step 3. audits for AFC (approved for construction) drawings, field inspections and reportingCompliance audits are normally carried out at the design phase of a project, by the engineers and owners, usually from a GEP perspective. The result normally captures a lot of potential issues, largely from a safety, regulatory, operability and maintainability perspective. However, often little or no auditing is carried out from a construction/field-execution perspective. The CQA manager should perform field audits, focused on high-risk/critical systems that have been identified during the risk and criticality analysis. The primary objective of the field audits should be to highlight construction-quality issues that may impact start-up/commissioning and hence the overall project schedule. The field auditing should be supported by a formal process to record, manage and resolve issues. Ideally, the CQA manager should also perform compliance audits on ’approved for construction‘ documentation prior to the start of work as well as review bid packages to assure that the requirements of the owner are included and delivered. This is applicable to both vendors and sub-contractors. Regular meetings should be held with vendors/sub-contractors in order to ensure that specifications are understood and appropriate procedures are in place.

step 4. establishment of appropriate field proceduresThe CQA manager should identify and establish appropriate field-testing procedures necessary to execute the project. The field-testing procedures should include inspection plans, commissioning protocols, test sheets, method statements, punch lists as well as procedures governing documentation format, storage and distribution.

step 5. traceability and control of field changesDuring the design/engineering phase, design changes are usually managed and controlled extremely closely. However, the management and control of field changes is usually overlooked. Often there are more

changes in the field than in the design phase. Therefore, traceability and control of field changes should be a high priority for the overall project team, because field changes may compromise commissionability/operability, safety, quality, schedule and costs. The CQA manager should ensure that field changes are properly assessed from a safety, commissionability/operability, quality, schedule and cost perspective. He/she should also ensure that the field changes are recorded, properly documented, dated, assigned accountability, audited, signed and properly filed. ‘Red Flag’ items should be prioritised for action.

step 6. use of appropriate construction formsAll check forms to be used for system fabrication, installation and testing should be in compliance with GEP requirements. The forms should also be checked for suitability and contents because they may be used as leveraged data to the commissioning phase, thereby eliminating duplication of effort.

step 7. turn-over package (TOP) definition and organisationThe CQA manager should develop the turn-over package (TOP) procedure, ideally at the pre-construction stage of the project. This should be discussed and agreed with the constructor and sub-contractors because they will, ultimately, be responsible for assembling the TOPs. The CQA manager should audit the development of the TOPs and conduct a final review at the hand-over stage. This should guarantee a high-quality package, which should include all required up-to-date documentation from vendors, engineering, construction activities, procurements etc.

step 8. training of key personnel and contractor staffThe quality culture of ‘right first time’ should be developed within the project team through a training programme. All key

construction personnel and sub-contracting staff directly involved in completing documentation for project TOPs should be trained, as a minimum, in GDP as well as relevant standard operating procedures and field procedures established for the project.

summary A good CQA programme should facilitate proper construction turn-over and ensure that systems are ready for commissioning. Ultimately, a facility with good construction quality and minimal defects is more likely to have a smooth and trouble-free transition into the commissioning/start-up phase of the project. It is also important to ensure that the CQA programme is not confused with the field-safety programme. In fact, both programmes should run parallel and mirror each other, aiming to deliver a facility with zero accidents and zero defects (see Figure 4).

conclusionThe selection of a good constructor is obviously very important. However, selecting a third party to perform CQA early on in the project will have a very significant impact on the project’s outcome. A clear commissioning strategy, underpinned with a good CQA programme, established at the pre-construction stage of the project, should help translate good engineering design into field execution/construction and help alleviate many of the problems encountered at the back end of a project. In the final analysis, especially from an owner/investor perspective: “A successful project is where a facility reaches optimal operation in a safe manner and in the shortest possible timeframe, achieving high availability and reliability during the first-cycle operation, maximising cash flow through the first-cycle operation!” tce

Jay Lad (jay.lad@spgl.eu) is managing director of SPGL, formerly Skanska Pharmaceutical Group, and Bruce Beck (beck_bruce_e@lilly.com) is director (global facility delivery) of Eli Lilly and Company

Figure 4: Construction quality modelled on safety programme

Safety programme

Contractor safety qualified

Safety assessment

Job specific safety plan

Safety procedures

Safety training

Safety monitoring

Quality programme

Contractor quality qualified

Quality assessment

Job specific quality plan

Quality procedures

Quality training

Quality monitoring

ZERO accidents and

defects