Validation Resources Blog

The Validation Resources blog is your one-stop shop for industry news, views & insights. The best informative articles, breaking news & tips for engineers. Covering topics on cGMP, Precision Cleaning and Process Validation.

Fluoride: Friend or Foe?

Emmet Tobin - Monday, August 15, 2016

 


 

 

 Does Fluoride Benefit Our Health or Pollute Our Bodies and Minds?

  • Fluoride in water systems and dental products continues to divide scientific opinion
  • Protagonists promote fluoride as a revolutionary panacea for dental diseases
  • Critics point to a lack of supporting evidence and a plethora of damning indictments

Fluoridation on Trial — Why Fluoride in Tap Water and Dental Products Is a Scientific Hot Potato

Following scientific research conducted in the early 20th century, the U.S. became the first country to introduce widespread artificial fluoridation of its drinking water. The trend spread to other nations including Ireland, Australia and New Zealand with a further 40 million people across the globe having access to naturally fluoridated water. Indeed, some parts of the world even have naturally occurring levels of fluoride in excess of recommended levels including parts of Africa, China and India. To further complicate matters, a host of countries have discontinued artificial water fluoridation in the face of mounting public angst and emerging scientific studies. Countries that have abandoned artificial water fluoridation include Finland, Germany, Japan, the Netherlands, Sweden and Switzerland. The map below shows levels of both natural and artificially fluoridated water received by populations around the world.


Fluoridation on Trial — Why Supporters Champion the Health Benefits of Fluoridation

The crux of the argument for artificially adding fluoride to water supplies centres on the prevention of tooth decay. In Western nations where fluoride is added to water systems, it is widely believed that artificial fluoridation plays a significant role in dental health and hygiene by strengthening the enamel of teeth and preventing tooth decay, cavities and ultimately the loss of teeth. A secondary hotly disputed advantage that has been propounded suggests that fluoride can help build up bone density. Proponents of water fluoridation will also regularly highlight the fact that fluoride already occurs naturally in groundwater and oceans and is effortlessly excreted by the kidneys meaning that it doesn’t accumulate in the human body.


Fluoridation on Trial — Is Scientific and Public Trust in Fluoridation Being Gradually Eroded?

Putting aside outlandish conspiracy theories and links to Nazi mass mind control programmes, the evidence and concerns about the toxicity of fluoride and the dangers it poses to human health have begun to mount in recent times. As well as increasing scepticism about the credibility of dated scientific research touting the benefits of fluoride, a new wave of studies has implicated fluoride as a risk factor for a raft of illnesses and conditions including certain cancers, destruction of teeth and bones, loss of fertility, ADHD, hypothyroidism, and endocrine dysfunction. Aside from studies showing a correlation or definitive links to ailments and diseases, opponents also point out that governments shouldn’t possess the power to mass-medicate entire populations with a drug intentionally added to a national water supply.


To fluoridate or not to fluoridate: that is the question. It’s a debate that’s unlikely to go away or be resolved anytime soon. More research, scientific scrutiny and sensible discourse would seem to be the only way forward to truly unravel the myths and discover what’s best for future generations.

Did you enjoy this content? Find out more details about the full range of guides, templates and tools exclusively designed for engineers at the ValidationResources.ie store.

 

The Pre-Mortem — A 4-Step Process for Project Management Prosperity

Emmet Tobin - Wednesday, June 29, 2016

 

 

How to Prosper While Safeguarding Your People, Projects and Profits

  • Prospective hindsight can accelerate your business’s bottom line and employee morale
  • Pragmatic planning can safeguard key project management milestones and eliminate errors
  • Why Benjamin Franklin knew that by failing to prepare, you are priming your project for peril

How Prospective Hindsight and the Pre-Mortem Project Management Strategy Breed Success

Is your organisation blighted by missed project milestones? Are the costs of project management dragging down your organisation’s employee morale and bottom line? Do you dread the endless finger-wagging, blame games and pearls of wisdom from hindsight? There is an alternative to this prosaic status quo. Most of us are consummate commentators when it comes to dissecting disasters and analysing the aftermath of missed milestones and failed strategies. But what if there was an alternative to the expensive inquests and arduous autopsies? What if you didn’t need to sacrifice your talent pool to save the numbers or tarnish your reputation to satisfy shareholders? Today’s blog examines an exciting approach to project management that lets you maintain morale, meet milestones and put money in the coffers without jeopardising you company’s culture or best assets.

At first glance, the idea of conducting a managerial pre-mortem may seem a peculiar and defeatist task. After all is said and done, people aim to please and we naturally want the best for our careers, projects and businesses. However, the scientific evidence bears out the fact that we are infinitely better at ploughing through the wreckage and lynching scapegoats than we are at putting in place the essential safeguards to ensure our projects succeed on time and on budget. Psychologists have coined this phenomenon the optimism bias and it impacts on our personal and professional lives on a daily basis. Is your business set up to be optimistic rather than realistic?

The pre-mortem project management strategy offers a simple 4-step process to allow your projects succeed while safeguarding your people, milestones and profits. The strategy necessitates a willingness to engage in frank, authentic discussions at all levels and an open mind to feedback and historical lessons. In short, the pre-mortem strategy requires short-term pain for long-term gain. Below is the 2016 take on ancient wisdom espoused by Benjamin Franklin and condensed into a 4-step strategy to revitalise your projects:

1. Widen Your Options

A major obstacle in modern decision making is humankind’s predilection for narrow framing or leaping on the first decent idea that surfaces. It is often manifested by viewing a problem in simple binary terms — yes or no, as opposed to later thinking and outside-the-box solutions. Moreover, research supports the glum view that many 21st-century companies seem to be using the same intuitive/impulsive decision-making processes as hormone-crazed teenagers leading to catastrophic failures of projects, businesses and global institutions. The antidote to this toxic thinking is to assume that none of your options will work forcing you and your team to conjure up practical solutions to circumvent anticipated roadblocks and issues. Consider setting up several teams from all levels within the organisation to eliminate or mitigate all likely problematic scenarios.

2. Road-Test Your Options

A second stealthy assassin of decision-making is the tendency to simply confirm your biases with your analysis by using self-serving information. To combat this, you must get outside your head and eschew historical routines in favour of proactively seeking out trustworthy data. One practical technique to accomplish this is to consider what would have to be true for your presumption to be the right choice. This clarifies thinking for your whole team and separates people from their biases as they analyse factors more diligently as opposed to falling back on tried-and-tested techniques and we’ve-always-done-it-this-way complacency and comfort zones.

3. Get Some Distance Before You Decide to Act

A third saboteur in bad decision-making is our hardwired inclination to permit our emotions to lead us astray. Discrediting your gut instinct and the importance of the power of intuition isn’t the goal here. The critical objective is to try to attain some distance between yourself and the decision to be made. Analysis paralysis (or should one say paralysis by analysis?) is the condition of rumination and poring over hypothetical situations to the point where a decision or action is never taken, in effect paralysing outcomes and jeopardising key project milestones. The serum in this particular case when you are struggling with several appealing alternatives is to ask yourself what advice you would give to your best friend or partner faced with a similar conundrum. The options will be the same but your perspective will most likely change quite dramatically.

4. Prepare to Be Wrong

Complacency, overconfidence and the 21st-century cult of positivity about how things will unfold tends to short-circuit our cognitive faculties and effortlessly distort our sense of what the future might bring. One sobering solution is to bookmark the future as an investment analyst might do by imagining both the best and the worst possible outcomes from a monetary decision. Being 100% risk-averse and completely insulated is impossible in the modern era but risk-taking needs to be exercised in a calculated and strategic manner rather than a long shot gamble. When the future is uncertain (i.e. always) it pays to anticipate all outcomes (good, bad and catastrophic) and to prepare resources accordingly.

Ultimately this is ancient wisdom repurposed for the 21st-century business environment. As simple as it might seem, the majority of project managers don’t account for human biases and hardwired instincts when taking key decisions. It’s nigh on time for businesses to start investing the same commitment and enthusiasm projects deserve from the get-go rather than footing the bill and fallout from a lack of upfront pragmatic planning.

Did you enjoy this content? Find out more details about the full range of guides, templates and tools exclusively designed for engineers at the ValidationResources.ie store.


 

Networking & Influence — How to Leverage the Power of Relationships

Emmet Tobin - Thursday, June 09, 2016

Take Your Career to the Next Level by Mastering the Art of Influence & Networking

  • Discovering the sweet spot between what you know and who you know can be a game changer
  • Building your network and the principle of reciprocity can have a multiplier effect for your career
  • Networking and strategic influencing can help you achieve the holy grail of a work-life balance

How Contacts, Connections and Colleagues Can Ignite a Stagnant Career

Are you a recent graduate looking to jump-start your career? An established mid-level engineer stuck in a rut? Maybe even an upper echelon-manager craving more recognition? Regardless of rank and experience, harnessing your connections and maximising your influence should be at the top of your personal development agenda if you really want to fulfil your potential. Undoubtedly, most readers will be familiar with trendy movements across the web and social media such as crowd funding and so-called random acts of kindness. However, fresh evidence is unmasking the real psychological drivers and neuroscience deep in the recesses of our not-so-selfless minds.

 

Quid Pro Quo & Reciprocity

A growing body of scientific studies are beginning to shed light on our subconscious motives for reciprocation, selflessness and kindness. The rationale for these popular phenomena is far less altruistic in nature than at first glance and appears to be fuelled by a deeply ingrained sense of duty and obligation towards our peers. Generosity is contagious so doing a good turn for a connection, contact or ex-colleague will likely be rewarded by a favour or vote of confidence down the line in a concept known as reciprocity by psychologists. Simply put, it can be explained by human nature and our hard-wired instinct to return favours to those who assist us in our hour of need.

Tools for Networking and Building Influence

Modern technology has opened up a whole new world of tools and apps that make it easier than ever to build your network, maintain relationships and reach out to the right people at just the right moment in your engineering career. Networking is neither confined by the limitations of travel, time and economical barriers nor by the necessity of face-to-face meetings. Some of the tools at your disposal include:

Attending physical conferences or webinars

Utilising social media for professional networking with channels such as LinkedIn and Twitter ✓

Smartphones and a huge choice of free communication apps such as Skype and Viber ✓

E-mail, post, fax, homing pigeons and horseback ✓

Face-to-face meet-and-greets, business cards and elevator pitches✓

Making Your Networking Mojo Work for You

Once you have chosen your influence and networking weapons of choice, you will need patience, perseverance and a genuine spirit of openness and engagement without the expectancy of instant pay-offs or overnight success. There’s no bible for being authentic but following some common sense steps will help you make the most of your current network and future opportunities:

Ask questions and try to actively participate in relevant conversations ✓

Be sure to take feedback positively and embrace the opinions and experience of others ✓

Don’t be afraid to call people by their first names to help build rapport and camaraderie ✓

Make sure that your business card and elevator pitch reflect your career aspirations and skill set ✓

Be yourself and get used to feeling comfortable in your own skin whether you are a hermit, introvert, ambivert or extrovert ✓

Did you enjoy this content? Find out more details about the full range of guides, templates and tools exclusively designed for engineers at the ValidationResources.ie store.

 

Overlearning

James Hanrahan - Sunday, May 08, 2016

 

Overlearning

Today we are going to examine the concept of Overlearning. Why focus on this in an engineering environment you ask? Change occurs in our field at such a fast past due to the introduction of new regulations, new processes, new machinery, new management, new scientific breakthroughs and technologies etc… it can be difficult at times to ensure that we are learning the right things, at the right time, and in the right way. There is a benefit in taking stock of ourselves and examining how we interact with new information, and uncovering the most effective way of learning it.

So when we’re learning a new idea, for example a new word, or a new concept, or a new problem solving approach, we sometimes tend to practice it over and over again during the same session. In a limited way, this approach is useful and necessary, but to continue “practicing” what you have mastered in the session is called overlearning.

 

 

Upcoming Training

GAMP for Engineers-30th May

 

Introduction to Quality Control- 10th June

 

ISO 13485 Medical Device QMS- 24th June

 

Location: Viking Hotel, Waterford

 

€290.00/person

 

However, Overlearning does have its value. It can produce automatic responses that can be important when you're executing a complicated sequence of actions, such as operating a new machine, a piloting an F16.

This automatic response has been termed “automaticity”. If you fail on tests or at public speaking, overlearning can be especially valuable. Even expert public speakers have been known to practice at least 70 hours, for a typical 20-minute TED Talk.

Automaticity can be helpful in times of nervousness, but you have to be wary of repetitive overlearning during a single session. Research has shown it can be a waste of valuable learning time.

The reality is, once you've gotten the basic idea, continuing to hammer away at it, during the same session, doesn't strengthen the kinds of long term memory connections you want to have strengthened. Worse still, focusing on one technique is a little like learning carpentry by only practicing with a hammer. After a while you think you can fix anything by just bashing at it!

Using a subsequent study session to repeat what you're trying to learn is perfectly fine and often valuable. However, you want to balance your studies by deliberately focusing on what you find more difficult. Focusing on the more difficult material is called deliberate practice. It's often what makes the difference between a good engineer and a great engineer.

Author: James Hanrahan – Managing & IT Consultant, Validation Resources Ltd.

 

 

 

PDCA Simplicity

Emmet Tobin - Thursday, May 05, 2016

All Quality Management Systems aim to build processes into the activities and culture of organisations. Simply put, a process is a set of predefined actions or steps that help reach a goal or target. Even when a company is not consciously aware of using a Process approach to tasks and problem solving, they are likely already using some processes. For example, a simple Work Instruction or Standard Operating Procedure (SOP) is a process in itself.

If a company is certified to ISO 9001, ISO 13485 or working to the FDA QS, the process approach is the perfect mind-set to drive consistency and meet targets. A familiar methodology used within many companies is the 5s methodology (Sort, Set-in-order, Shine, Standardise, Sustain) . This methodology is an organisational methodology which is very effective in ensuring a work environment is clean, organised and fit for purpose.

Another powerful methodology (shown above) is PDCA which stands for Plan-Do-Check-Act. A benefit of using this methodology is its design allows a visual representation for each segment. This helps clearly set out the tasks relating to each stage of the project or tasks and when they are to be completed. Below is a brief breakdown of each segment of PDCA.

Plan

The Plan step is used to establish the objectives and desired goals of the proposed changes or modifications. Documenting these goals is important as it will drive aspects of the next steps in the Process.

Do

Implement the plan and the changes identified. The “Do” step may require data collection and/or analysis prior to the implementation of changes. Training may also be required. Responsibilities should be clearly defined.

Check 

Review results and analysis against the planned and expected results or goals.

Act

The “act” step ensures if any further corrective actions or modifications are noticed in the check step, the person will “act” on the findings. However, any proposed changes are better captured by returning to the first step and starting the process again, either way, the application of PDCA will make tasks that little bit more consistent. You can download our PDCA template online. Visit validationresources.ie and go to the “Engineering tools” catalogue.

Pomodoro for Engineers Part II

James Hanrahan - Wednesday, April 20, 2016

In the last edition, we introduced you to the Pomodoro technique. Due to the positive nature of the feedback we received on that article, and the many people who looked for more information, we decided to run another article to expand on the technique.

In order to grasp how and why the Pomodoro technique works, we must first look at how the brain works.

There are two modes of “thinking” that have different modes of “operation” in the brain, namely Focused and Diffused.
And knowing the difference between the two, can make learning more productive!

 

 

Introducing Knowledge Box . . .


Let’s start with diffuse thinking. Diffuse thinking is the method the brain employs when you are in a relaxed state. It happens when you are falling asleep, when exercising, or just chilling out. Here, pathways (groups of associated neurons) fire up and flash on and off attempting to “come up” with new patterns based on the day’s learnings and experiences. Most good eureka ideas happen while in the “diffused mode’.

Focused thinking, is the method employed when concentrating on a particular task, or while learning new material. During the “focused mode”, the brain is attempting to ‘create’ or recall, a specific neural pattern. This mode of thought requires a larger energy input than the diffused mode. Neurons fire out tentacle like appendages called dendrites, little spears that look to “handshake” with the synapses of the other dendrites. It is the connection of two dendrites (via their tips called synapses) that starts the formation of new neural patterns. The process outlined above requires energy. Lots of energy. And, this is why multi-tasking does not work!

Specifically, multi-tasking involves the brain firing up other patterns of neurons that are nowhere near relevant to the task at hand. Not to mention requiring energy that should be routed elsewhere.

The brain can hold, form and ‘recall’ neural patterns, successfully only if uninterrupted, and for periods of no more than 25 minutes at a time. Any longer than this and the brain begins to ‘loose focus’. This results in you becoming easily distracted, agitated, and feeling like “nothing is going in”. Through practice of the Pomodoro technique, you can learn how to keep your brain running at an optimal level, thus ensuring productivity. The following are some helpful tips to aid you in performing your first ‘Pomodoro’:

1.Choose a task: Select one task and one task only. For many multi-taskers, this may feel like a step backward in productivity. But after a while, you’ll find you are much more efficient when you give all your focus to one task.

2. Set a timer for 25 minutes: Yes, just 25 minutes. Don’t worry about whether or not the task can be completed in that time. Just get as far as you can.

3. Work on your task until the timer rings. Then put a checkmark on a tracker: Remember, that’s 25 minutes of steady, focused work on ONE task. No emails. No phone calls. No checking Facebook. No distractions permitted!

4. Take a 5-minute break: You’ve just completed your first Pomodoro! Go ahead, update your Facebook. Send that email.

By James Hanrahan, Change Management & IT Consultant.

 

3D Printing

Emmet Tobin - Tuesday, April 12, 2016

It is hard to escape the explosion of 3D printing stories in the media. Especially within the last couple of years, developments in 3D printing appear even in the mainstream media. 3D printing is quite revolutionary and brings together design, material science, engineering and computing expertise. In a recent BBC Radio 4 programme, it described the technology as “a revolution which the world hasn't seen since the dawn of the Industrial Revolution over 200 years ago “.

3D Printers are now manufacturing a variety of products including medical devices, tissue scaffolds, aeroplane parts and machine components to name a few.

Background

Originally referred to Rapid prototyping, 3D printing is essentially a layering process which builds up a shape by the deposition of small amounts of material. After many hundred (or thousands) of layers, the desired shape of the product is achieved. Depending on the configuration of the 3D printer and the scale of the build, it can take many hours to complete the process. This “time to print” factor is a leading challenge for most 3D printers. I remember preparing a 3D printer on a Friday afternoon to build a component over the weekend. Often to come in on a Monday, and find it had “crashed” with an error. But errors aside, even more modern equipment still demonstrates a slow cycle time. This can be tolerated for expensive, once-off products or components, but does not make sense for many low cost, high-volume products or components.

False conceptions

A lot of people incorrectly believe that 3D printing is confined to small parts and products. However, that is not the case. Formula 1 teams and Aeronautical engineers have used them since the 1980’s building prototypes in order to understand designs better and develop improvements. Larger 3D printing system are less common due to the high costs.

Creating structure

When it comes to living organisms, tissue engineering and organ development, 3D printing is now a tool that is increasingly used. While printing “tissue” is typically not possible, cells can be printed into a support structure known as a scaffold, which then entices tissue generation and growth. Another example of the power of 3D printing is found in the next generation stents used to unblock veins and arteries. 3D printing offers the accuracy and resolution required for these implantable medical devices, and when combined with novel materials, they can provide the ideal structural and physiological conditions.

Want to learn more?

Check out the BBC Radio 4 podcast on 3D bioprinting here - http://www.bbc.co.uk/programmes/b05pn3t4
 

 Abbot Vascular also have a good overview video of the Absorb Bioresorbable Vascular Scaffold (BVS) Systems, visit www.abbottvascular.com. 

Biodegradable like no other!

Emmet Tobin - Friday, April 08, 2016

“Plastics are made by fools like me, but only God can make a tree”

I’ve always had a keen interest in the materials of Engineering and in recent years my interest has grown particularly with regard to Wood, as I have become somewhat of an amateur stickmaker.

While wood and timber have a wide range of uses, they are not suited to every application. Naturally, their use in any regulated industry is limited, but wood is the perfect “role model material” for engineers and material scientists seeking out the holy grail of biodegradable and renewable materials.

Such a benefit of wood is its high weight to strength ratio, which is comparable with mild steel (believe it or not).

For many years, mainstream thought has suggested that we are on the cusp of a revolution in materials used in Engineering and packaging etc. While there have been clear and measurable advances, the availability and application of these new materials has not had a transformative effect in the wider community or across different industries, with relatively high costs and low consumption rates symptomatic of new materials.

Wood and timber products are commonly available, cheap and effective. With this in mind, we can learn much from wood and its properties and it would be a shame to overlook its strengths.

Wood, if left exposed to the environment, will eventually degrade over time. However, simple treatments with preservatives, paints or varnishes, can prevent or slow the effects of the environment.

The Rise of PLGA  

Enough talk about wood! Introducing another biodegradable material- PLGA. PLGA is not only biodegradable but is also a biocompatible copolymer that is used and approved for use in regulated industries such as the medical device industry. It has many applications including fracture fixation and in recent years has been used to manufacture biodegradable stents. The key process allowing PLGA to degrade is throughHydrolysis which occurs in the presence of water. This biodegrading and resorption property makes it a very attractive material, simply using the chemistry and physiology of the body to start the process. We spoke of wood treatments with paints or varnish, similarly, PLGA implants can be coated in order to provide therapeutic drugs or it can be coated to control the rate of degradation, particularly in the early stages of use.

As with many biodegradable materials, PLGA is expensive and therefore it is not commonly used other than in medical devices. However, if in time, these materials can be made more cost friendly, it could open up the possibilities of wider applications.

The Future

It will be difficult for materials such as PLGA to ever reach the consumption rates like wood or timber, nor is the need likely, but increasingly material scientists look to nature in order to inspire or inform their next advancements. If you are interested in material science, I recommend reading the classic book by J.E Gordon, “The New Science of Strong materials (or why you don’t fall through the floor.) In his final chapter, entitled, “The materials of the future” he oddly offers little insight, asserting that speculation only offers a receipe in “how to guess incorrecty” . On this note, I too will refrain from further speculation.

Pomodoro for Engineers

James Hanrahan - Monday, April 04, 2016

Maximizing time for most engineers is a constant struggle, not to mention the toll it can take on your home life. In a busy work environment, it can be a struggle to meet endless deadlines and project milestones.

There are many time-management techniques that maybe employed to improve your productivity. However, most are impractical or require more effort than they are worth.

Enter the Pomodoro technique...

Pomodoro is the Italian for tomato, and from it, little kitchen timers were born, resembling the humble pomodoro. In the 1980s, a practice was developed to act as an aid for those finding it difficult to both study, and be productive while working.

What is the Pomodoro Technique?

The Pomodoro technique involves dividing your day, not into work hours, but “pomodoros”. Each omodoro is 25 minutes long.

The 25-minute Pomodoro maximizes time and efficiency, by setting out 25 minutes of uninterrupted focus on a particular task or project. Basically you work in 25minutes stints, after which you take a break.

The two key takeaways here are that the work is no less or more than 25-minutes at a time, and that the work is uninterrupted.

 

 


Not according researchers studying the brain, such as Dr. Terrence Sejnowski of the Salk Institute for Biological Studies, where he directs the Computational Neurobiology Laboratory.

Think it’s all hokum?

Dr. Sejnowski’s research has demonstrated that the human brain works at an optimal level when focused on learning or work, for periods of up to 25 minutes at a time. After which the “brain” requires a short 5 -10-minute break. While the brain is focused on a particular task that requires all of your attention, there reaches a point of diminishing returns after 25-minutes without a (short) break.

According to the body of work being carried out at the Salk Institute, the brain learns and focuses using groups of neurons to form patterns. The brain “maxes out” after 25-minute periods. No different than your PC or laptop slowing down after running a large programme or set of tasks.

Additionally, constant interruptions and distractions stop the brain from forming its new neural “pattern”. This is why turning your phone onto silent, turning off your email and Facebook, are so important while doing a “Pomodoro”.

Try it! Do 25-minute stints of uninterrupted study and work and see how much you can get done!

Sources: Learning how to Learn (and Work) Barbara Oakley, Oakland University

The Computational Brain, Dr Terrence Sejnowski, The Salk Institute.

 

 

Process Validation -Hidden Benefits

Emmet Tobin - Tuesday, March 29, 2016

If you are lucky enough to work in the medical device or pharmaceutical industries, you will probably be familiar with the requirements of Validation, at least to some degree, regardless of your role or responsibilities.

If, like me, you are even luckier enough to be a Validation Engineer, you have likely endured the brunt of resentment that sometimes can be attributed with validation. Validation can be seen to suck time and resources from the goal of production.

For several years now, I have peddled the usual benefits of Validation to whom and where necessary. Just to bore you one final time, the traditionally claimed benefits of Validation include compliance to regulations (a must), benefits to product quality and potential cost savings. However, after taking time to reflect on the goals and spoils of validation, I have developed a new way of thinking about it – here it is!

Communication

Validation forces communication- yes we have morning meetings, team huddles and the like. But validation forces the best form of communication -cross functional roles working together and sharing responsibility. I have been afforded the opportunity to work closely with other Engineers and frequently with operators and technicians.

Big business

A key theme of validation is that of “consistency”. We seek consistent materials, processes and products that meet the requirements of customers while meeting all legal and regulatory conditions. However, as a business grows and particularly, when it expands to more than one site or location, there is an inherent risk of a drift in policy or procedures. Validation keeps this in check and as it is evidence based, it can clearly highlight differences in performance, procedures or the quality of products.

The Little guy

Finally, Small to medium sized companies can benefit from validating their equipment and processes. This can include Engineering companies that provide CNC processing, laser machining and other support to the larger medical device and pharmaceutical companies. Having validated systems is a badge of honor and provides an extra layer of confidence to the customer. If you happen to sell equipment direct to other Med device or pharma companies, having a proven IQ/OQ/PQ template and framework for qualification can make it a very attractive sweetener for regulated companies. Many packaging companies now offer a Validation Pack as a service or add-on. If you are interested in tips and templates, check out our selection online.