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Multichem Business Project Management Evaluation

Info: 12017 words (48 pages) Dissertation
Published: 10th Dec 2019

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Tagged: Project Management

Executive Summary 


The objective of this report is two-fold:

  1. To provide a retrospective evaluation of the current management of projects, programmes and portfolios relating to the ‘Multichem®’ brand of products within my Organisation, Technopath Clinical Diagnostics (TCD), in order to identify our strengths and weaknesses.
  2. To propose recommendations geared towards a prospective improvement process against current strategic objectives and the gaps identified, in order to reshape the lens through which our Stakeholders define success.


The scope of this report applies to the management of the Research & Development Project & Programmes of the Portfolio of Multichem® Quality Control product designs. Recommendations are evidence-based and appropriate to my context as manager of projects and programmes of projects within R&D.



Current usage of Technopath Clinical Diagnostic’s consolidated Multichem® product line has gained them market access into the general chemistry and immunoassay laboratories worldwide. Considering a very successful recent history of expansion of both manufacturing facility and acquisition of two major new global supply agreements, TCD’s rapidly growing Customer base is set to continue, to help fulfil the mission of improving millions of patients’ lives across the globe.

As with all rapid expansions that are consequent of successful business results, TCD will need to implement measures to reduce risk in order to maintain its overall efficiency and effectiveness as a global leader, over the long term. Risk is an uncertain event or condition that has a positive or negative effect on tactical projects, strategic programmes and thus outcomes and benefits of strategic importance.

Make sure the problem is defined in clear, understandable terms.Provide a solution. A problem is always in need of a solution. In order to deliver a claim statement of purpose (and a reason to fund the venture), you need to present your solution so that it effectively tackles the problem. If your problem isn’t clearly written, your solution is less likely to make sense.Use graphics, bullet points, and headings if the document is easier to skim that way. An executive summary is not an essay; it doesn’t need to be long blocks of text. If they enhance understanding or make the summary more skimmable, it’s okay to use:

Graphics. A well-placed graphic illustrating the precise nature of the client’s problem could drive home the point of the summary. Stimulating the visual sense is often just as effective as their analytical sense.

Bullets. Long lists of information can be broken down into more digestible bullets.

Headings. Organize the themes of the summary, if necessary, by heading. This will help orient the reader as they dive into the summary.Keep the writing fresh and jargon-free. Jargon is the enemy of understanding. It just so happens to be popular in the business world. Words like “interface,” “leverage,” “core competency,” and “burning platform” are all words that you should strive to avoid. They obscure real meaning and can make the summary sound vague and devoid of specifics.Start with the original document. Since the executive summary is a summary of another document, you’ll need to be pretty familiar with the original document in order to condense it down to a manageable and informative version. Whether that original document is a report, business plan, proposal, manual or different document, review it, looking for its main ideas.Write a brief review. What is the purpose of the company sponsoring the document, or of the original document itself? What is its scope?

Make the “grab” shine. This section is probably the most important part of your entire executive summary. In two or three sentences you should tell the reader why your business is special. Why does it deserve the scrutiny, business, or partnership of the people reading the summary?

Maybe you have Michael Jordan as a customer and he has endorsed your product on Twitter for free. Maybe you just signed a partnership agreement with Google. Maybe you were just awarded a patent, or maybe you just made your first big sale.

Sometimes just a simple quote or testimonial is enough. The key is to grab the attention of your audience, make the business appear as reputable as possible, and draw the reader in to the rest of the document.Define the big problem. The first real ingredient of an executive summary is a discussion of a problem, so explain the problem that your products/services address. Make sure the problem is defined as clearly as possible. An ill-defined problem doesn’t sound convincing, and won’t set up your solution to be as impactful as it could be.Deliver your unique solution. The big problem is the easy part. Now you have to convince the reader that you have come up with a unique solution for the big problem. If you deliver these two ingredients, you’ll have the makings of a great idea.Talk about market potential. Elaborate on the big problem by providing stats for your industry. Be careful not to pretend that you have a larger market than you do! The fact that the medical device industry is $100 billion annually means nothing because your new medical device will only serve a small segment of the industry. Break it down to a realistic market potential.Incorporate your unique selling proposition. This is where you elaborate on your unique solution.“How will you get people to take dollars out of their wallet and give them to you?” Keep the model simple, especially in the executive summary. A quick summary is all that is needed.Discuss your management team, if necessary. Depending on what industry you are in, this can be one of the most important parts of your executive summary. Your investors or bankers are putting trust in the team, not the idea. Ideas are easy to come by, but executing on those ideas can only be accomplished with a strong team. Quickly show why your team has the experience and knowledge to execute your business plan.Provide financial projections to support your claims. Based on your market, your business model, and your historical performance, you need to develop a bottom-up financial forecast. The point of your projections is simply to demonstrate your competence, and your ability to build financial projections based on a sound set of assumptions.Ease in to your request. Now it’s time to request either an investment or loan, depending on the purpose of the executive summary. You should restate why your company provides value. Remind the reader of the big pain that you are solving and your market potential.Reread your summary. When you have written the basics, reread it carefully. You should proofread the summary with extra care. While you are rereading, also consider your audience for the document. Make sure any new references are explained and that the language will be clear to someone who is new to this topic. Rewrite as necessary.

Have a pair of fresh eyes reread your executive summary, paying special attention to:

Clarity. Are the words clear, the ideas clearer, and the summary devoid of jargon?

Errors. Grammatical, punctuation, and spelling errors may abound. Having someone fact-check the figures and statistics might be a good ideal as well.

Forcefulness. Do the ideas translate into a stirring pitch? Where does the pitch fall flat, if at all?

Coherence. What parts don’t fit together? What parts do?


Potential Grabs

With more than 20 years in the shoe manufacturing industry, Acme Shoes has a track record for successful design, manufacturing, and distribution of quality shoes.

ABC Co. provides clients with reliable, high-quality services in the industry. We are a company dedicated to satisfying our customers in order to keep them coming back. Our commitment to quality and service makes us a valid and worthwhile investment.

Quality Parts emphasizes development of the most popular parts with the highest need. Our supply philosophy allows us to meet the needs of the widest range of customers, creating a great supply for a high demand.

At XYZ Services, the client comes first. By meeting the needs of every customer that walks through our doors, we create a word-of-mouth marketing model that allows us to expand dramatically within our industry.

Problems and Solutions

Problem Solution
Electricity is getting more expensive every day, not to mention the fact that the carbon emissions associated with utility-based power supply are increasing annually. Renewable energy can be a cost-effective, eco-friendly way to save money in the long run. An installer can come to your home and analyze your energy needs and design a system customized to fit your current and future needs.
Store front windows are always large, get dirty often, and take a long time to clean. Assigning employees to clean them can often in end in less than desirable results. A professional window cleaning service offers reasonable pricing and exceptional results. With a weekly, scheduled service, your windows will always be clear and clean, with the added benefit of saving you valuable time to run your business.
Buying pre-made baked goods offers some convenience and maybe some small savings, but it can often turn out in poor flavor, flat decorations, and a boring centerpiece. Ordering custom, fresh-baked cakes, cupcakes, breads, pastries and more offers a personal touch, filled with great, made-from-scratch flavor. Having the freedom to choose the flavor, icing, theme and presentation allows the customer to create anything their heart desires for any occasion.


Mission Statement

The mission of Acme Office Furniture Store is to successfully supply businesses of all sizes with their office furniture needs. The company’s customer-oriented mission is stated in our Corporate Promise:

  • Offer a diverse profile of office furniture, from simple to high-end pieces, at competitively low prices
  • Provide excellent customer service through knowledgeable, friendly, and helpful sales people
  • Provide sufficient replacements, repairs, and refunds for any dissatisfied customers

This mission will carry these principles of the company onto the retail floor, as well as into the e-commerce environment.


Acme Office Furniture Store’s primary objective is to be a competitive player in the office furniture market. Currently, the majority of sales traffic comes from local businesses and some outlying areas already under contract with the company on the e-commerce side. As new expansion is under way to establish two more stores in Banksville, MA and Georgeville, MA, Acme intends to also promote their online sales division through aggressive internet marketing, and local cable advertising. This expansion will enable Acme to realize substantial sales growth over the next five years so that it can achieve specific financial objectives:

  • Increase potential client base from thousands to millions by increasing exposure from local to national markets
  • Increase sales revenue, margins and profitability
  • Break even by the end of year one, and increase profitability every year for the next four years

Company Information

Acme Office Furniture Store started in the garage of Michael J. Banks. Starting with custom-made furniture sold by word-of-mouth and over the Internet, Michael developed his skills and built his business until he was able to afford a manufacturing warehouse, where all furniture is now constructed.

The newly developed retail store, as well as the manufacturing plant and e-commerce division, employ a total of 113 employees.

Growth Highlights

Over the past five years, Acme Office Furniture Store has grown from a small corner store to an entire sales floor with an average increase in revenue of 37% each year. In 2012, Acme grossed $98,000 from the retail floor, in addition to another $86,000 from e-commerce alone.


Acme provides a wide range of office furniture solutions, from a full line of ergonomically designed office chairs, to their Standard and Executive lines of quality desks, as well as cubicles, artwork, and more. Overall, Acme Office Furniture Supply meets the following office furniture needs:

  • Desks
  • Chairs
  • Cabinets
  • Storage furniture
  • Seating
  • Tables
  • Accents and accessories


Overview of Technopath Clinical Diagnostics

Technopath Clinical Diagnostics (TCD) is a medical device company that designs, develops and manufactures third party quality control (QC) products under the brand name ‘Multichem®’ for use in the IVD (In Vitro Diagnostic) industry. An ‘in vitro’ diagnostic is a method of performing a diagnostic test outside of a living body in an artificial environment, usually a laboratory. The expression ‘in vitro’ comes from Latin, literally meaning ‘within the glass’.  The term “third party” means that the quality control products helps provide an independent assessment of a diagnostic device or method.

In 2004 TCD pioneered the development of the world’s first truly consolidated quality control material for hospital laboratories. Current usage of TCD’s consolidated product line has gained them market access into the general chemistry and immunoassay laboratories worldwide. Consolidation of quality control materials helps hospitals to enhance the quality of patient test results, while significantly reducing handling requirements and reducing the generation of hazardous waste.

Refer to Figure 1 for an overview of Multichem® projects and programmes launched worldwide by TCD between 2013 and 2017.

Additional to the Multichem portfolio of products, there are two separate but supporting branches of the Organisation.  IVD raw materials using proprietary processing techniques and fully customised to satisfy the raw material requirements of the IVD industry. Companies in research and development and manufacture of diagnostic reagents, calibrators and controls and proficiency testing samples typically use these as raw materials. The second separate branch is TCD Informatics, which has designed a Diagnostic Informatics software package called ‘IAMQC® Software’. This software provides Laboratory Managers with a range of QC software tools to analyse their QC results and peer data in real-time. “For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytical process.” (42 CFR Part 493.1256 Medicare, Medicaid, and CLIA Programs; Laboratory Requirements Relating to Quality Systems and Certain Personnel Qualifications; Final Rule). The IAMQC Software products allow users to automate and centralise their QC data management processes in a laboratory setting.

Module Aims, Methodology and Purpose and Scope of Report

Module aims: Module MN6901: Project and Programme Management Science and Principles explores the core concepts and theories of project management science and relates them to the emerging phenomenon of programme management. It provides learners with a deepened understanding of project, programme related principles, and associated strategic and operational frameworks, and how they may be integrated within a variety of Organisational settings.



  1. An in-depth study of the module recommended prime texts and other relevant texts literature (refer to Bibliography) relevant to this module.
  2. Review of academic papers presented by academics from practitioners’ perspectives and any other external associated universal literature on concepts of Project and Programme management.
  3. Engagement with the lectures and learning resources presented by the Module Lecturer for each week of the Module.
  4. Interactive and collaborative engagement with peers on the various weekly e-tivities, drawing on evidence of having engaged with content and reflected on impact on practice, with the objective of applying studied theory to my own context and current role.
  5. Application of appropriate tools and techniques designed to give the practical skills relevant to the structure and content of this report.


To complete a management consultancy report based on Technopath Clinical Diagnostics. The purpose of this assignment is to apply the concepts, knowledge and theory I have learned during the course of the module MN6901 to my own context, structured according to the headings and sub-headings in the contents section.

The objective is to provide both a summative/retrospective evaluation of the management of projects, programmes and portfolios within my Organisation against a pre-set standard, in order to identify our strengths and weaknesses as well as a formative evaluation which is a prospective improvement process against objectives and the gaps identified.  (Thiry, chapter 3 , Gower 4th edition)




The scope of this report applies to the management of the Research & Development Project & Programmes of the Multichem Quality Control product designs. Recommendations are evidence-based and appropriate to my context as manager of projects and programmes within R&D.



Figure 1: Multichem Product Portfolio (Source: Turner, R. (2014) Gower Handbook of Project Management 5th edition, Gower Handbook of Project Management, ‘An Organisations Investment Portfolio’, Fig. 27.1, p434)

Multichem Portfolio of Quality Controls 2012 to 2017


Programme 1: Multi-Analyte Abbott Control  Programme

Jan 2012- May 2013

Programme 3: Multi-CHECK Cardia and

RANGE-CHECK Programme Sept 2014-March 2015

Programme 2: Esoterics Control  Programme 2014-2017





RANGE-CHECK Calibrator Verifier

5 Components/4 Levels

Multi-CHECK Cardiac Control

5 Components/3 Levels

Project 4:

‘CSF’ (Cerebrospinal Fluid Control)

4 Components /2 Levels

Apr2015 – Oct 2016

‘Project 1:

NB’ (Neonatal Bilirubin)

4 Components/ 1 Level supplement high

Jan to August 2014

Project 2:

‘AE’ (Ammonia Ethanol)

2 Components /2 Levels

Jan 2014-April 2015

Project 5:

‘IA L4/AMH’ (Fertility Control)

9/1 Components & 3 Levels

Feb 2014-May 2017

Project 3:

‘A1c’ (Diabetes Control)

1 Analyte/3 Levels

Jan 2014-May 2017

Project 1:

‘IA /IA Plus ‘ (Immunoassay Control)

59 Components

Project 3:


(Urine Control)

13 Components

Project 4


(Protein Control)

16 Components

Project 2:

‘S /S Plus’ (Clinical Chemistry Control)

66 Components

Project 5

‘WBT’ (Whole Blood Transplant)

3 Components

Programme 4: I-PLAQ IVD Test System on Multiple Analyser Platforms

Sept 2015 to May 2017

Project ‘hsTn’ Control

2 Components/ 1 Level supplement low

September To Nov 2014

Change Control ‘AE’ (Ammonia Ethanol)

To 3 levels

Dec 2016

Change Control ‘A1C’ to apply on HPLC Premier June 2016


‘IA Speciality’ Control

2 Components/ 3 Levels

Feb 2015 –Oct 2016

I-PLAQ Reagent

Change Control 14 days to 28 days OB

Change Control 12 pack to 3 pack

I-PLAQ Calibrator

Change Control ‘A1C’ re-design for Premier

June 2016- Sept 2017

Change Control ‘hsTn’ Control

2 Components/ 1 Level Lower concentration due to emerging prognostic

I-PLAQ Control set 1 Analyte, 2 levels

Change Control ‘IA Speciality’ Control

6 Components/ 3 Levels

Change Control ‘A1C’ Add Architect application

2018 Pipeline


Feb 2014 – May 2017

New smaller bottle kit concept for low throughput laboratories

Urine Calibrator

D-Dimer Control

Linearity Pools

DAU Control

Pool 1 -CC

Protein Calibrator

Pool 2 -IA

BHR Cardiochek

Pool 3 – P



Pool 4 – U

Section 1: Industry and Organisational Drivers of Project Management within Technopath Clinical Diagnostics.

The Business Development team at TCD keeps well abreast with latest innovative technological and IVD industry advancement, in order to capture gaps in the market relating to new developments in diagnostic products and analyser applications.  Although the Organisation may formulate an associated deliberate strategy, our business must and does anticipate that inevitable change in the market will warrant the necessary emergent strategies that become evident with time (Mintzberg and Quinn, 1996). The primary Organisational drivers that are driving project management within my organisation relate directly to the external drivers influencing the ever-progressing technology of the IVD industry. As new medical IVD tests emerge onto the market, it identifies the need for an associated quality control material.

Three key concepts drives programme management within our Organisation: Organisational Governance, Stakeholder Management and Benefits Realisation (Turner 2014). The Organisation defines its objectives based on its industry, market and governance. Governance is how those objectives are defined, communicated and benefits realised through project delivery (Thiry, 2004).

A robust whole management system is utilised within Technopath Clinical Diagnostics, which aligns with these three concepts of programme management.  This system is borne out from four factors (Parsons, 1977); goal attainment, integration, adaptation to change and long-term maintenance/monitoring.

TCD is an SME (Small/Medium Enterprise) with all the same regulatory requirements and design control stipulations of a large multinational corporate company.  The R&D Team coupled with the existing competent professionals within Business Development have significant qualifications and scientific, industrial and quality experience in the development of consolidated fluids for use within the diagnostic industry. Supported by a strong Finance and Quality teams, we continually evolve to implement smarter methods of project management, to deliver on time and within budget, in order to survive against our biggest Competitors. Combined effective planning involving Business Development, Finance and R&D for projects and programmes of projects allows us to work smarter, reduce stress levels and gain efficiencies with each new project approach. The overall objective is to produce a realistic, reliable plan that adequately represents stakeholders’ requirements (Zwikael, 2009).

The identification of the business need or opportunity in the business case focusses our project and programme management to the following two primary drivers:

  1. Project Stakeholder Management
  2. Project Integration Management

Stakeholder management aligns closely with TCD business strategy. Integration

Integration as the primary knowledge area of the project management phase encompasses all other knowledge areas, particularly at the initiating and planning process stages, which set the foundations of the project. It is an interactive process of unification and consolidation of activities that traverses all five core phases of the project lifecycle; Initiating, Planning, Executing, Monitoring & Controlling, and Closing.


Project Stakeholder Management

“Measuring and anticipating the needs and expectations of stakeholders. The information is used to set policies, strategies and objectives. Excellence is achieving results that delight all the organisation’s stakeholders” (The Fundamental Concepts of EFQM, 2003).

The Association for Project Management (APM) Body of Knowledge (BoK) 5th Edition defines stakeholders as “all those with an interest or role in the project or who are impacted by the project”.

Stakeholder management devises user needs which links up with the design inputs. Project Stakeholder management at the early initiating and planning phases identifies the market segments and End Users the device intends to serve. It highlights the path for gathering of source information, literature research, currently available on market methodologies. It prompts clinical research to determine the clinical requirements, for example test system capability, precision specimen type, typical user specimen handling conditions. It facilitates competitive analysis research, assessment of on market competitor usage/anticipated frequency. Stakeholder management continues throughout the project lifecycle. Refer to Figure 2 (a&b) which gives a graphic representation of each knowledge area as it relates to project management within my Organisation, as well as the reasons for what is driving the relative priority.


Project & Programme Integration Management

Integration is vital in driving the project overall but particularly in the Initiating and Planning Phases where the aspects of Stakeholder Identification, Stakeholder Expectations, User Needs and Project Definition are critical in presenting a realistic way forward for the planning aspects of the other knowledge areas of scope, time, cost, quality and human resources.

Systems thinking is required for programmes of projects that are aligned with Company goals. Programme management is a centralised, co-ordinated, integration management through a set of processes that are structured and designed to achieve the programmes’ strategic objects and benefits. It requires a management approach that is more holistic and goes beyond the task oriented project management.  Regardless of the time factor, where projects can outlive programmes, they differ in the way that programmes are managed, as oriented towards ‘whole systems thinking’ and realisations in the future whereas projects are task oriented to satisfy needs of the present (Parsons, 1977).

Relative Priority of Project Management Bodies of Knowledge PMBOK® within TCD.

In line with the inception of harmonised global standards, the PMBoKs (Project Management Bodies of Knowledge) developed as a standard guideline to support Organisations to standardise their approach to project management. It is a two dimensional framework across five core management processes and ten knowledge areas (reference Figure 2). The relative priority of each of the ten knowledge areas within TCD project and programme management, starting with the highest priority at number 1 are:

  1. Integration
  2. Stakeholders
  3. Risk
  4. Procurement
  5. Scope
  6. Communications
  7. Human Resources
  8. Time
  9. Cost
  10. Quality

Figure 2 presents how each PMBOK® knowledge area and components relate to each of its corresponding five core management processes. It also demonstrates how each of the ten PMBOK® knowledge areas relate to the management of projects within Technopath Clinical Diagnostics (TCD) Organisation. The relative priority of each of the ten knowledge areas PMBOK® within Technopath Clinical Diagnostics are correspondingly set out in Figure 2, as well as the reasons for what is driving this relative priority.

Some consider that the PMBOK® is prescriptive. It is an instrumental framework with specific inputs, outputs, tools and techniques. Project management is accomplished through the appropriate application and integration of the 47 logically grouped management processes, which are categorised into five process groups. It is a guideline that clearly states within its context that it identifies the subset of knowledge areas that is ‘generally recognised ‘ as good practice. ((PMBOK® Guide, 5th Edition, p17).  It was founded both as an outcome of consistent historical failures and inconsistency of project outcomes (Morris 2011), and out of concern for project management competence (Crawford 2005). It requires project managers to be able to extract the logic and therefore should not be ascribed a standard set of gaps.

A distinctive methodology that will apply to all project undertakings is never possible, not even for projects within the same discipline. Projects are too varied across different disciplines and generally too complex to be standardised. The BoKs merely provide PMPs with a framework within which experience, insight and judgment are applied systematically to manage projects.  Successful project management does require the application of PMP skills, competencies, and critical thinking to recognise the limitations of all standards. The BoKs should provide adequate material to support the creation of a logical and flexible framework for project management approach as long as the technical and leadership competencies required exist within the project management group.

In 1991 the APM (Association of Project Management) produced a broader document which gave recognition to objectives, strategy, technology, environment, people, business and commercial issues.  The APMBoK (Association of Project Management Body of Knowledge, 5th Edition) has a broader scope than the PMBOK® and the APMBoK is conceptually concerned with the management of projects rather than focussed on project management topics specifically.

The management of projects and programmes within Technopath aligns more closely with the APMBoK guide, where the project management process provides the single point of integrative responsibility. The management of projects achieves this by defining, documenting the user needs, the usability specifications, defining and agreeing the inputs and outputs, transferring the design outputs, ensuring that the transferred procedures are defined and documented correctly and training is effectively delivered for the purpose of routine operations. Additionally, there are other integrative whole systems approach involving risk management application to medical devices and post launch risk monitoring, post market surveillance activities which are directly aligned with project outcomes.  Figure XXXX under Section III of this report shows how our current project management process compares with the APMBoK project lifecycle.


Conclusions and Recommendation:


Conclusion: Through the assignment of the relative priority of the BoKs to my own context, I consider the relative priority of each of the ten knowledge areas within Technopath applicable to the management of projects involving product development. However, I have identified an opportunity for improvement within this current TCD project management process without changing those relative priorities.

Recently, since taking up an additional role within Operations, it has become apparent to me that post project lifecycle; there is evidence of misinterpretation of processes and procedures within Operations.

This may have to do with many aspects:

  • Lack of definition or inadequate translation from technical aspects on the transfer of design outputs to procedures, leading to lack of understanding.
  • Departure of knowledgeable, skilled and competent personnel and recruitment of many new personnel over the years due to the expansion of the facility, coupled with a general lack of training and development of new personnel within the long transferred operations.
  • Inadequate human resources or overstretching of existing competent resources to facilitate this training within the Operations environment.
  • Lack of training and development as well inadequate leadership necessary for the development of employee trust aspects.
  • Compromise of the original ‘whole systems’ structure implemented for the Organisational quality procedures so that they have moved from a compliant, flexible and logical situation to a compliant, inflexible, inconsistent and disconnected situation. Processes that are too inflexible and rigid, and only focus on documentation compliance, and do not focus on competence, present a potential to compromise the quality of the product (Turner, 2007).

Recommendation: I am limiting my recommendation for opportunity for improvement in this section to the current TCD project management process without changing the relative priorities of the knowledge areas as I see them.  Post commercial assessment and project charter approval via Gate 1, the first executed process of formal design control at TCD is  a risk analysis/brainstorming technique; FMEA (Failure Modes and Effects Analysis/ IEC 60812:2006 Analysis techniques for system reliability – Procedure for FMEA). This process currently sits post formal project approval and may not include enough representatives from the internal set of Stakeholders. This risk prioritisation tool addresses the design intent (usability) and considers potential failure modes and effects on both systems and product components operation early in the design development process. This design tool/planning, integration and Stakeholder management process is multi-functional. It primarily serves as a roadmap for actions in design control.

I would recommend that going forward product design and process should precede project approval, at the initial stages of design concept and definition.  It should also accompany all change control proposals, without exception.  All internal Stakeholders representatives within the Organisation, including those representing external Stakeholders, (Marketing & Business Development) and those representing internal, (Engineering, Quality Control, Quality Assurance, Regulatory Authority and Operations) should attend the ‘preliminary’ FMEA at pre-implementation stage of project approval. This action would solicit the input of the Stakeholders at an early stage and help each department to identify the requirements for their department and plan resources post project at an earlier stage. In addition, it may become apparent through this initial stage that specific equipment may be required or that Marketing team may need to conduct further research to obtain the information necessary in relation to User specifications or anticipated product usage profiles. The Validation Engineers may have to look into automation, specific filling or labelling mechanisms etc. As a result of this analysis, and the fact that in reality within TCD risk knowledge area is assigned third highest priority, it makes sense that it will better serve Stakeholders and all project constraints for project approval, if implemented earlier , even if the process output were to be revisited and revised within design control.




Section 2: Project/Programmes Alignment with Strategy


Good governance practice requires formal alignment of portfolio, programme and project plans to business strategy (APM, 2004).

History of project management indicates that the perspective was too much around accomplishing the project goals using tools and techniques (Morris, 2011) and from the 1970s to the 1990s the focus on project performance increased, from the perspective of technological adequacy, project design and institution building (Baum and Tolbert, 1985), (Morris, 2011). The typical sources of difficulty within projects however still exist today. These include unclear success criteria, changing sponsor strategy, poor project definition, concurrency, poor quality assurance, poor linkage with sales and marketing, inappropriate contracting strategy, unsupportive political environment, lack of top management support, inadequate manpower. As shown by Cooke-Davies (2005), only 7% of all projects deliver 100% of the benefits expected, while >66% deliver less than 75% of the expected benefits.

In the early 2000s, Miller and Lessard (Morris, 2011) reported a critical distinction between the efficiency (on time, within budget, within scope) and the effectiveness (achieving the beneficial outcome) of projects.  During 2004 and 2006, a network of academics, practitioners and consultants, funded by the EPSRC, undertook a research programme, to develop the field of project management beyond its current foundations. Although the mainstream image is still product creation and focus on output, a higher focus is emerging on outcome and value creation. The most popular definition of success in project management these days is “meeting promised project benefits”, (International Journal of Project Management (2006), Vol. 24, Issue 8).

The inputs and outputs of a project help achieve the outcomes of a project which represent the value and benefits being sought.  If the business case, (which according to Turner (1999) is the deal between the sponsoring organisation and the project team is under resourced, from a budget, time and human resource perspective, then there is a risk that the scope, quality and outputs may not be achieved. This situation adversely impacts the ‘how’ (Winter and Szczepanek, 2009) and directly affects outcomes, value and business benefits.

In order to execute the strategy, the context in which the project is executed has to be monitored and controlled. However, as recommended by the APMBoK, in order to plan the strategy, consideration must be given to:

  • The need to understand how the success of the project will be measured, from the Sponsor and Stakeholders’ perspectives.
  • How the project will deliver value.

Even stable and equilibrated whole systems will continuously suffer from the effects of a changing environment, and fail within some sub-system or process by default. Programme management is grounded in strategic concepts as opposed to project concepts and exhibit high uncertainty (Thiry 2004).  As advocated by Thiry (2004) programme management must address ambiguity and the potential for change. That’s when our support processes within the whole system like Quality CAPA (Corrective Action/Preventive Action)  help us to review, investigate, identify and repair the out-dated or failing parts and improve them, for that system to return to a state of equilibrium

Cooke-Davies (2007) 10 commandments of Benefits Management sets out clearly the governance structures that need to be created to focus on and harvest business benefits by the Organisation. In brief, these are:

  1. Nurture a culture of co-operation
  2. Define responsibilities of the individual roles of the project sponsor, project manager, and other stakeholders for coherency with the objectives.
  3. Identify all stakeholders who will contribute.
  4. Prior to project approval, ensure that the overall project plan includes business case and  how benefits will be realised from the outputs,
  5. Ensure that the organisation’s project activity can be translated from its overall corporate strategy.
  6. Continually review the business case for adequacy at each design review stage during the project, versus the project performance and the business environment.
  7. Incorporate the anticipated benefits and plans into the overall project plan.
  8. Develop metrics for each stage.
  9. Integrate risk management principles into the benefits management process
  10. Communicate and keep all Stakeholders continually informed of project status versus benefits plan.

The inputs and outputs of a project help achieve the outcomes of a project which represent the value and benefits being sought.  If the business case, (which according to Turner (1999) is the deal between the sponsoring organisation and the project team is under resourced, from a budget, time and human resource perspective, then there is a risk that the scope, quality and outputs may not be achieved. This situation adversely impacts the ‘how’ (Winter and Szczepanek, 2008) and directly affects outcomes, value and business benefits.

The overall organisational focus by TCD on benefits programmes and projects alignment with strategy is shown in Figure 3.

Figure 3: “Beginning with the End in Mind” (Turner, 2007)

Satisfies Purpose, Solves a problem Exploits an Opportunity

Beneficial Outcome, Return on Investment

Project: Idea or Conception

Change, Output Asset

Project Sponsor reviews project progress and reaps operational benefits

Project Team Manages and Delivers Output

Project planning Stage 1: Plan Description

Introduction and summary

  • Concept, Feasibility

Commitment acceptance

  • Commercial


  • Feasibility: identify those ideas worth developing further Find a Sponsor. Collect information and appoint the project manager

Project Work Breakdown Structure

  •  Planning of all activities & Cost elements, risks

Schedule & Statement of Work

  • Applications: defining the desired output in financial terms Requirements for each task, balance time, cost, integrity of specification and risk. Identify resources.
  • Authorization/ Approval Finalise the agreement

Project planning Stage 2: Control Plan , Control & Co-ordinate progress. Manage change to Plan.


  • Implementation including design verification and validation
  • Monitoring & controlling periodic reviews of task outcomes and updates to Sponsor & team. Continually assess & manage risks.
  • Completion and handover. Disband Project team
  • Operation: running of the changed operation or output/asset to deliver the expected benefit,
  • Close down and cessation of project operations
  • Termination and disposal of residual assets.

“Successful project management is all about managing benefit”. (Cooke-Davies, 2007)

Tangible Value:

  • Increased Revenue
  • Reduced Costs
  • Increased Productivity
  • Reduced Errors


Intangible Value:

  • Improved Customer Satisfaction
  • Improved Morale
  • Improved Quality
  • Enhance Effectiveness

Executive Sponsor/Customer Services & Financial Controller can demonstrate to stakeholders that the desired benefits have been delivered.

  • Improved Customer Satisfaction
  • Improved Morale
  • Improved Quality
  • Enhance Effectiveness

Project Sponsor/Owner  ‘Single Point Responsibility’ (Cooke-Davies, 2007) to oversee Project to ensure Benefits are Realised                                                                          To Success


Executive Sponsor & usually Project Owner: Sound Business Case/Project Charter/Anticipated Benefits justify investment. Minimise Corporate Risk

Project Manager: Project Plan takes account of Benefits Delivery through periodic business reviews

Operations/Post Project Owner: The full impact of the benefits delivery plan is reflected in the operations budgets.




Source: Turner, R. (2007) Gower handbook of project management, 4th edition, ‘THE BENEFICIAL CHANGE’, p.98 Cooke-Davies, T. (2014), Chapter 13, Managing Benefits’

As R&D Manager in charge of programmes and projects relating to new product development and design changes post launch, I deliberately seek out the established hierarchy of deliberate strategic objectives at the beginning of each financial year so that I can cascade them (Archibald, 2003) to R&D Department objectives (Archibald, 2003). Refer to Figures 4, 5 and 6.


Figure 4: TCD: FY2017 Company Objectives translatedto R&D Objectives.

Figure 5: R&D Manager Goals translated to Team Objectives for new product developments.

Figure 6: Team Objectives for Change Controls/Design Change Improvements aligned with emergent strategies. 

Section 3: Project Lifecycle at TCD

Q3: Map out what phases a typical project in your organisation goes through in terms of a lifecycle – this should be presented diagrammatically with a brief accompanying text describing the process.

Consider if this is appropriate, what is driving the current lifecycle and what (if any) recommendations you would make in this regard?

Although not an integral part of an IVD test system, delivering a patient result, Quality Controls are classified as IVDs/Medical Devices, since they are components of IVD test systems. Strict Quality System Regulations govern the design of IVDs.

 The management of R&D Projects & Programmes at TCD utilise an internal procedure QP-12 Design and Development process that is aligned with the requirements of the standard ISO13485 Medical devices — Quality management systems — Requirements for regulatory purposes.

A compilation of documentation that describes the design history of each of the finished medical devices is required to be stored for the entire product lifecycle, product lifecycle being how long it is live on the market.  An overview of design control and design output and documentation transfer requirements and how TCD Quality procedures for design control and design change align are documented to QSR (Quality System Regulations) in Figures 2 to 4. Formal design control of an IVD involves adherence to the relevant TCD established design and development ‘QP-12’ procedure, as aligned to:

  • US FDA Design Control Guidance For Medical Device Manufacturers (March 11, 1997)
  • In-vitro diagnostics directive (IVDD) 98/79/EC
  • U.S. Food and Drug Administration 21 CFR 820
  • ISO13485 Quality management systems – Requirements for regulatory purposes
  • Canada Medical Device Regulations SOR/98-282, May 7, 1998.

The Stakeholder and User Needs establish the intended uses and product requirements. This user needs document is a design control tool that is initiated within the planning phase and links with the product & process design input requirements. It documents all Stakeholder needs from Customer, to End User to Manufacturing Operations within our own Organisation, considering the environmental and safety aspects, procurement of new raw materials/process/material handling, reliability of raw material supply, if critical raw materials require second supplier. A Project Initiation form is a form of documented communication that is completed by the Business Development Group as a result of market research and business contract proposals.

This Form defines:

1. The details of the Project request to the R&D group

2. New Product or Change to existing Product

3. Reason for Request (Marketing Need / Intended Use)

4. Priority (over other agreed/approved or pipeline R&D projects)

5. Desired Implementation Timeframe

6. Proposed Markets: EMEAIC/US/Americas/Japan

7. Key Customers identified

8. Prediction of Annual Sales & Revenue/No. of Kits first year and subsequent years per kit concept

This relatively new approach has significantly reduced the continuous challenge that prevailed historically where project definition and tangible sales forecasts were not available to drive the commercial assessment part of the project presentation for approval.


  1. It facilitates realistic cost estimation for materials, human resources, capital expenditure, field trials and large scale manufacture & labour costs.
  2. It helps identify complexity at an early stage and time required in feasibility to establish the design blueprint (MSP, ????).
  3. Identification of the Stakeholders facilitates the preparation of the User Needs document
  4. User needs links to the design inputs required
  5. It supports the preparation of the Gate 1’ project charter document.

Figure 2: QP-12; TCD Design and Development Process as applicable to new IVD products marketed in Technopath packaging

QF213 Gate 3: Design Inputs


QF 211 – Gate 1 Project Approval

Gate 5: Design Validation


QF212 Gate 2: User Needs & Specifications


Gate 6: Pre Launch


QF214 Gate 4: Verification & Design Outputs



Figure 3: QP-12 TCD Design and Development Extended Process (Adapted from Medical Devices Bureau, Health Canada)


User Needs

Design Input

Design Process

Design Output


Medical Device




Figure 4: TCD QP-38 Design Changes Post Launch Process (Adapted from Medical Devices Bureau, Health Canada)


QP: 38 Design Change/ Modification required

Design Input

Design Process

Design Output

Verification of change if required

Updated Product Specification

Validation if required



Figure xxxx: TCD Process versus PMI Project Lifecycle

The main QSR elements of design control for medical devices are:

Product Design Verification: Confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.

Product Design Validation: Confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled.

Additionally, all medical device products in design and development are subject to application of risk control/reduction measures, as aligned with ISO14971 Application of Risk Management to Medical Devices.

Current Approach to Project Management at Technopath Clinical Diagnostics.

R&D, in conjunction with information obtained from the Business Development team, Marketing, Operations and Finance groups compile the ‘Gate 1’ project charter for the control to be designed.

A ‘project Initiation form’ has been designed by the teams specifically to capture the information required by the R&D Project /Programme Manager in relation to Market, User & Stakeholder needs, kit concept, usage profiles, competitive analysis. Personnel within the Business Development Department complete this form.

This form clarifies:

  1. The details of the Project request to the R&D group. The ‘What’ that will be designed. The required outputs, supporting the scope and quality
  2. New Product or Change to existing Product. The ‘How’ it will be managed from the Quality perspective, supporting the scope. New product requires the ‘Gate 1’ , Change to existing product requires a change control to be raised, documenting the nature of the change, the reason and the justification based on the anticipated outcomes, tangible and intangible value and benefits.
  3. Reason for Request. The ‘Why’ based on Marketing Need / Intended Use.
  4. Priority (over other agreed/approved or pipeline R&D projects), considering outcomes, tangible and intangible value and benefits to Stakeholders.
  5. Desired Implementation Timeframe, supporting the prediction of the cost and time constraints.
  6. Proposed Markets: EMEAIC/US/Americas/Japan, supporting the scope, time, cost, quality and identification of Stakeholders and the cost and time constraints.
  7. Key Customers identified, supporting the scope, time, cost, quality and identification of Stakeholders and the cost and time constraints
  8. Prediction of Annual Sales & Revenue/No. of Kits first year and subsequent years per kit concept.

Overall Conclusions and Recommendations:

As a result of the analysis of industry organisational drivers of project management, and the fact that in reality within TCD risk is assigned a high priority, it would better serve Stakeholders and all project constraints for project approval if implemented earlier, prior to Gate 1 project charter approval. Even if the process outputs need to be revised within design control, implementation of this tool at an earlier stage will more accurately define the project constraints of scope, quality, schedule, cost, resources and risks, at an earlier stage, prior to project approval.



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