Assured Quality Saves Money


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Recent IChemE article: "In harsh economic times, Quality saves time and money!"

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Assured Quality Saves Money

  1. 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. 48 december 2011/ january 2012housinglad JLv3 DF CFW AD.indd 48 08/12/2011 15:47
  2. 2. CAREERS HOUSING & CONSTRUCTION tce 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 december 2011/ january 2012 49housinglad JLv3 DF CFW AD.indd 49 08/12/2011 15:47
  3. 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 ( 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 ( is CQA is not natural to many contractors issues. On the Kinsale biotech project there managing director with SPGL 50 december 2011/ january 2012housinglad JLv3 DF CFW AD.indd 50 08/12/2011 15:47
  4. 4. tce PLANT COMMISSIONING & DECOMMISSIONINGCan 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-effectivetop 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 resultingthey examine trends and pharmaceutical market sectors. from poor quality are no longer acceptable inin construction, the Although companies, governments and today’s marketplace. investors cautiously continue to commit For many years and with dramatic cost tokey to successful capital, there is more pressure today than our economy, the construction sector hascommissioning 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 toFigure 1: Commissioning flow chart the successful outcome of a project.48 july 2011
  5. 5. CAREERS PLANT COMMISSIONING & DECOMMISSIONING tcethe field game Figure 2: Project scalingUnlike design/engineering companies, 3rd party CQA:whose focus is on QbD, construction Audits against CQA plan, owner’s CQA programme advisor, conducts field inspectionscompanies 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-contractorstask completion and safety. Ideally, field Contractor: Executes contract, QA self-inspectionsafety and quality should be combined todeliver projects with zero accidents and Project total direct cost **zero defects. Indeed, many construction >$150mcompanies do not have a quality manual/programme and often fail to see the intrinsic $100–$150mlink between quality and safety. $75–$100m At the outset of a project the appropriate $50–$75mlevel of quality must be determined for $35–$50mevery phase. This is usually establishedfor the engineering phase. However, it is $25–$35moften overlooked for the construction and $15–$25mcommissioning phases, which are probably $10-$15mthe two most critical phases that impactoperability, availability, reliability and $5–$10mmaintainability of a facility. <$5m A good constructor should normally Risk = FN {project complexity + contractor quality experience}have a commissioning plan developed atthe pre-construction stage. The objective 1 2 3 4 5 6 7 8 9 10being that the most critical and hazardousparts of the project are fully mapped out (Identify values for project complexity and contractor quality experience, and add together)and costed, even before the constructionhas started (see Figure 1 for an approach to Project complexity (examples) Contractor quality experiencecommissioning). 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 equipmentand check sheets, is of little value if theconstruction of the overall facility is of Warehouse with temperature control, 3 Projects without alliance contractors 3a poor quality and littered with defects. laboratory, administration facilitiesTherefore, the overall commissioning effort Medium-sized process facility, non- Projects with limited owner 4 4will ultimately prove to be more dangerous, regulated industry experienced contractorstroublesome and costly. Large scale, complex, regulated It is clear from the above that, at the process facility (eg pharmaceutical, 5 No previous owner experience 5pre-construction stage, the approach to biotech, nuclear etc)construction quality and commissioningshould be fully established in a construction ** Project total direct cost only includes shell, building and process equipmentquality and commissioning plan. The levelof quality/checking to be applied to theproject should be clearly laid out and fullyunderstood 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’? july 2011 49
  6. 6. tce PLANT COMMISSIONING & DECOMMISSIONING A commissioning firm that understandsquality and its application in the field as Pre-constructability study Design Design QA/QCwell as commissioning requirements may – Design auditsbe 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 analysisthey carry out this role in a cost-effective – Traceability of changesand independent manner, but also add great Procurement GEP documentationvalue to both the constructor and the owner. requirements from vendors/ So how can a commissioning firm deliver suppliersthe 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 analysisand GDP to suit construction as outlined – Sub-contractor assessmentsbelow. – Audits for AFC and in the field Installation Site acceptance tests (SATs) – Establishment of appropriateCQA programme field testing procedures – Traceability and control of field At the pre-construction stage of a project, a changesgood construction manager will normally – Use of appropriate construction formsprepare a construction quality plan (CQP), – Turn-over package (TOP) attempting to document the key steps definition and organisation Mechanical testingnecessary to deliver a building/facility that is – Training of key personnel and contractor stafffit for its intended purpose. However, a planis simply just a plan and, unless it is part ofan overall integrated field-quality assurance Pre-commissioningprogramme, it often proves to be ineffective.Quality by inspection is limited and unless Integrated construction,an integrated approach is adopted, success commissioning and Commissioningis a probability rather than a certainty! qualification A CQA programme should aim to ‘Handover of a fully commissioning and qualifiedapply quality concepts and practices facility’to the construction activities to ensure Performance trialsthat the facility is delivered on time, asspecified, defect free and in an operablestate. One of the primary objectives of the In operationCQA programme should be to raise theimportance of quality and self-inspection/testing to the constructor/sub-contractorsin order to prevent deficiencies, minimise Figure 3: Approach to project qualitydefective work and strive towards a zerocritical-items punch list. However, theoverall responsibility for the construction the outcome is a trouble-free commissioning/ is significant because critical systems, orquality should never be removed from the start-up, ensuring a reduced ’time to market higher-risk systems, require a higher level ofconstructor/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 identifyowners to use contractors with varying levels The CQA programme should form the and assess the risks to the project from aof 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 alsogaps/deficiencies of step 1. risk assessment and from a commissioning and schedule-impactthe 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 assessmentand 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 teamappropriate corrective design phase of a project, by the engineers to identify and prioritise quality/schedule-actions will be crucialto 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 impact50 july 2011
  7. 7. CAREERS PLANT COMMISSIONING & DECOMMISSIONING tceschedule/cost, it is essential to audit the Figure 4: Construction quality modelledcontractors responsible for these systems, on safety programmein order to ensure that they have theappropriate quality systems, commissioningplans, method statements and check sheets Safety Qualityto prevent deficiencies and minimise programme programmedefective work. Understanding the gaps/ Contractor safety qualified Contractor quality qualified ZEROdeficiencies of the key contractors early Safety assessment Quality assessment accidents andin the project and implementing the Job specific safety plan Job specific quality planappropriate corrective actions will be crucial defects Safety procedures Quality proceduresto the overall success of the project. Safety training Quality trainingstep 3. audits for AFC (approved Safety monitoring Quality monitoringfor construction) drawings, fieldinspections and reportingCompliance audits are normally carried changes in the field than in the design phase. construction personnel and sub-contractingout at the design phase of a project, by the Therefore, traceability and control of field staff directly involved in completingengineers and owners, usually from a GEP changes should be a high priority for the documentation for project TOPs should beperspective. The result normally captures a overall project team, because field changes trained, as a minimum, in GDP as well aslot of potential issues, largely from a safety, may compromise commissionability/ relevant standard operating procedures andregulatory, operability and maintainability operability, safety, quality, schedule and field procedures established for the project.perspective. However, often little or no costs. summaryauditing is carried out from a construction/ The CQA manager should ensure that A good CQA programme should facilitatefield-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 constructionthat have been identified during the risk and she should also ensure that the field changes quality and minimal defects is more likelycriticality analysis. The primary objective are recorded, properly documented, dated, to have a smooth and trouble-free transitionof the field audits should be to highlight assigned accountability, audited, signed and into the commissioning/start-up phase ofconstruction-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 CQAoverall 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 programmesrecord, 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 zeroperform 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 the start of work as well as review bid The forms should also be checked for conclusionpackages to assure that the requirements suitability and contents because they may be The selection of a good constructor isof 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 earlycontractors. Regular meetings should be effort. on in the project will have a very significantheld with vendors/sub-contractors in order impact on the project’s outcome. A clearto ensure that specifications are understood step 7. turn-over package (TOP) commissioning strategy, underpinned withand 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 engineeringappropriate field procedures pre-construction stage of the project. This design into field execution/constructionThe CQA manager should identify should be discussed and agreed with the and help alleviate many of the problemsand establish appropriate field-testing constructor and sub-contractors because encountered at the back end of a project. Inprocedures 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 isinclude inspection plans, commissioning should audit the development of the TOPs where a facility reaches optimal operation inprotocols, test sheets, method statements, and conduct a final review at the hand- a safe manner and in the shortest possiblepunch lists as well as procedures governing over stage. This should guarantee a high- timeframe, achieving high availability anddocumentation 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!” tcestep 5. traceability and control procurements etc.of field changesDuring the design/engineering phase, step 8. training of key personnel Jay Lad ( is managingdesign changes are usually managed and and contractor staff director of SPGL, formerly Skanskacontrolled extremely closely. However, the The quality culture of ‘right first time’ Pharmaceutical Group, and Bruce Beckmanagement and control of field changes should be developed within the project ( is director (globalis usually overlooked. Often there are more team through a training programme. All key facility delivery) of Eli Lilly and Company july 2011 51