Horizon West in the Western People

Project Manager or Engineer? Why not both?

It's been a busy week, but after a phone call on Tuesday it opened up the debate...should Engineers be taught how to project manage in college or are they natural born project managers?


I was told it was natural for those who studied design based courses to be good at project management i.e. that they instinctively know how to define, review, gather and manage information, whereas Engineers are the doers, i.e tell me what to do and I will do it! 


Now personally this is not something I would totally agree with. Yes Engineers are doers and excel at the execution of projects. As a Mechanical Engineer (a non designer) myself and having started in the electronic manufacturing industry I was thrown in at the deep end and had to learn very quickly how to project manage. But to be honest, it wasn't a big learning curve(maybe I was lucky). My college had structured our programme and final year project into research, collate and a final deliverable, which now looking back are the fundamentals of project management.


Still working with Engineers I see those who are not in the R&D side of Engineering are, for all intents and purposes, Engineering "Project Managers". They know the ins and outs of the "engineering" side of the business but they manage the day to day running of the project.


The main focus and grounding an engineer needs is to be inquisitive and imaginative to provide alternatives and improvements to processes, products and systems.


So it would seem to be that yes, Engineers ultimately become project managers as they progress through their careers but maybe a little help while in college would make that transition from Engineer to Engineering Project Manager all the smoother....

Horizon West: Engineering firm aims to generate 20 new jobs

An introduction to Lean Validation

An introduction to Lean Validation: reduce waste and make the validation lifecycle flow

Lean Validation is an approach that harnesses the methods and activities from Lean Manufacturing Principles (i.e. The Toyota Way) that can provide an overarching structure to plan and develop a validation system that is successful and ensures that all planned activities performed within the system can demonstrate with confidence that the validation will fulfil the requirements for quality and safety, with special regards to the areas of:

• Risk Management
• Validation Change Control
• Project Management

As mentioned by Wong, W. and Chatterjee, B. (2007), traditional validation is based on

meeting corporate and market demand — regardless of the cost to the stakeholders of the company. The old adage “validate anything that moves but don’t move anything that’s already

validated” sums up the traditional view of validation. This mindset essentially

discourages innovation and continuous improvement and is partly why validation is perceived as a necessary evil rather than a value-added activity. Despite extensive

sampling and testing, companies are often unable to achieve process stability. Processes fail because the drivers for stability have not been properly identified and eliminated or controlled. Validation and it’s back bone that is Risk Management is not a once off effort but a living,breathing part of the business model.

In his book Liker calls the Toyota Way, "a system designed to provide the tools for people to continually improve their work."^[1]The system can be summarized in 14 principles.
According to Liker, the 14 principles of The Toyota Way are organized in four sections: I) Long-Term Philosophy, II) The Right Process Will Produce the Right Results, III) Add Value to the Organization by Developing Your People, and IV) Continuously Solving Root Problems Drives Organizational Learning.

These 14 principles can be easily transferred to the application of risk based Lean Validation:

Section I — Long-Term Philosophy

The first principle involves managing with a long-view rather than for short-term gain. It’s all in the planning as they say, plan the work and work the plan, validation and the use of validation master plans (VMPs) are no exceptions to this rule.

Section II — The Right Process Will Produce the Right Results

The next seven principles are focused on process with an eye towards quality outcome. Following these principles, validation work processes can be redesigned to eliminate waste (muda) through the process of continuous improvement — kaizen.
By performing a gap analysis of the current validation infrastructure will identify the “muda” and asses how robust the system is in regards to business and regulatory risks.
Utilizing kaizen techniques can help simplify the validation suite of documents that rationalize procedures, guidelines and macro-driven templates.
Simplification of the review and approval processes is also part of the principle of measured production rate (heijunka), as a level workload helps avoid overburdening people and equipment (muri), but this is also intended to minimize waste (muda) and avoid uneven production levels (mura).

Section III — Add Value to the Organization by Developing Your People

Human development is the focus of principles 9 through 11. Leadership needs to be embraced by all the key stakeholders in the validation system through the likes of a Validation Review Board supported by a dedicated valiation team. Driven with the judegement of success by their team acheivements rather than their individual efforts help minimise the cultural resistance of change. Ensuring that the lean validation principles are ingrained in all team members is perhaps the most difficult hurdle to overcome in the run up to a regulatory inspection.
Engineering has evolved primarily to satisfy commercial needs; however, there are certain elements of engineering by way of associated risks that have regulatory significance. The ISPE C&Q baseline guide addresses this particular issue with an impact assessment tool; a simple and effective way of separating commercial risk from regulatory risk.
Section IV — Continuously Solving Root Problems Drives Organizational Learning

The process of developing a robust diagnostic tool that is Lean Validation lends itself to the final principles. By becoming a "learning organization" which continually reflects on its practices and strives for improvement.

In summary, the main benefits that a Lean Validation driven organization will have is a transparent validation process that flows throughout the total lifecycle, waste is minimized with a strong emphasis on a right first time approach. Furthermore a lean validation organization promotes a scientific & data-driven process and encourages a preventative approach to quality issues and encourages a proactive control of all risks and uncertainty while improving transparency within the organization and with associated regulatory bodies & agencies.

Lean validation will always have the greater compliance needs in mind, not only safeguarding the products, and the people who use them, it will be seen in so many respects to safeguard 'the company’.

1^ Liker, J. 2004. "The 14 Principles of the Toyota Way: An Executive Summary of the Culture Behind TPS",

ISO...don't be afraid!

Becoming ISO certified can often be perceived as a monster and an arduous paper based assignment which regularly begs the question “Do we really need ISO?”

The answer to this question is YES! If correctly managed ISO certification can provide a company with a very valuable framework around which to maintain and continually improve its business. From my own stand point, having witnessed and experienced many Quality Systems, there are a number of points which must be addressed very early on in the implementation process as they say, “Tús maith leath na hoibre” (a good start halves the work).

1. Engage with your Notified Body

e.g. NSAI, who can help you and provide you with information on the certification process (and costs).

2. Be prepared

Ensure you have a full understanding of the ISO standard you are aiming to implement.

3. Ownership

Assign a knowledgeable owner and leader of the ISO implementation project who can spearhead a cross functional team to success.

4.Gap Analysis

Complete a GAP Analysis against the standard (you may find out you are adhering to parts of the standard already)

5. Project Plan

Develop a project plan and set a date for your certification audit (otherwise it can go on and on and on and…I think you get the idea!

 ……Oh and don’t be afraid to ask for help!!

ISO is a roadmap which guides your company along a structured path. It helps you put a framework around your business and helps you ensure that all of your processes flow. Being audited and certified by a 3^rd party also gives your customer’s confidence in your abilities and your processes.