Insight Blog

Learning Process Validation through Human Relationships

I remember with fondness of my late mother chatting with me while she was working on her clothes on her Singer sewing machine during my teens, about human relationships.

“Know what you want, know what the other person wants. Keep trying till it works and always remember to take nothing for granted”

Sound advice for me, which I remember to this day.

Be it common wisdom, wise advice from parents, or just the plethora of ‘how to.. ‘ or “X easy steps to do this..”, there’s no shortage of material written about how we build lasting relationships.

 

 

We all have plans for a relationship, such as a life partner, a business partner, a family member, or even a close friend. These are people that matter to our lives, people that we care, but at the same time, we have our perception of our expectations, our requirements for what this relationship is giving us and fulfilling us. We assess a person or situation based on risk, which decides how much we can ‘trust’.

Perhaps we develop a “mental checklist” that we believe applies this relationship – be it wealth, fame, security, support, company. For example, is my prospective life partner able to provide me a comfortable life and eternal companionship? Does my friend have the same interests or outlook of life as me? Does my business partner have the same business goals that can take us to greater heights? Whichever it may be, it is a must to communicate them.

 

 

We spend time interacting with this person, and this is when during the course of this interaction that trials and tribulations occur. The best of times, the worst of times. Some runs are great, some result in great conflict, frustration, disappointment, or even disenchantment. But eventually ‘everything works out’ if this relationship is able to overcome these odds, then it is able to determine what works best. Then we take steps to ensure that the relationship is able to withstand the test of time and still consistently meet each other’s expectations and requirements. You would want your life partners to love you yesterday, today, and tomorrow. Your business partner continues to provide reliable business dealings.

Of course, the world is not static and as the earth spins at 1670 kilometres per hour, perhaps this explains why our lives are moving quickly too. Circumstances and the environment changes constantly. We have little hints here and there giving us signs and signals if things are going well, or not. This is where the relationship once again needs to prove that it can continually meet each other’s expectations and requirements, this continued reassurance of one’s commitment to the relationship needs to exist so that we can still expect to see it being the same long-term.

 

Isn’t this a bit like process validation in the healthcare industry?

What has all this got to do with process validation?

Where’s the link?

Process validation is defined as the collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product.

Process validation has always been termed as a scientific study, an examination of process capability, but ironically I have found it to mirror our outlook to having a successful relationship which in most parts is an extremely human, emotional experience. So how is it similar?

 

Note the same values of having a plan, expectations and requirements – this is no different from having a validation plan, knowing what you need to validate based on risk, critical-to-quality (CTQ) parameters, and validation inputs, right?

 

Installation Qualification – ticking the boxes

Just as we talked about making sure the relationship successfully ticks every box in the checklist, Installation Qualification (IQ) talks about having the equipment installed correctly, ticking every box from air to water to power to documentation to training, to equipment commissioning. If we want to ‘tick every box’ in a relationship, surely we can ensure all the boxes are ticked in IQ? If one or more ‘box’ is not ticked, do you walk away from the relationship because it’s a red flag or make it work because it’s still salvageable? That depends, but so does in IQ – it depends on the CTQs.

 

Operational Qualification – experiencing trials and tribulations

In any relationship we go through all sorts of trials and tribulations, the best and worst of times – That is no different from doing that process capability study to find the worst case limits for this process in Operation Qualification (OQ). Isn’t any relationship – the process – operating within certain limits, compromises and constraints? Wouldn’t you want to find out all the parameter combinations that work out well?

 

Performance Qualification – is the behaviour consistent

Does it withstand the test of time? Is the behaviour consistent? We need time and sufficient assurance that it is indeed the case. That’s the intent of Performance Qualification – establishing confidence through appropriate measures that the expected results from a process are consistently reproducible. Ever heard of the ‘three runs’ rule of thumb? While that is an industry rule of thumb, do we really believe those three production runs could tell us anything about process stability and capability? Yes, it’s not possible to wait eons till the process becomes stable. However, what is possible is to integrate OQ with PQ such that the true worst case scenarios are indeed being challenged.

 

Validation Changes – a conscious assessment

Just as in relationships we have situational and environmental changes, so does processes. Some of these changes have a profound impact on that “validated state” and you take actions to reassure that we can continue to meet our commitments established in PQ. Some of these changes don’t require you to take action. The key is to make a conscious assessment

“if it’s not documented, it didn’t happen”

Don’t we always ask for evidence whether we know what we want, did we tick the boxes, do we know what works, and did we profess the commitment that we would remain consistent? Did we not seek approval or endorsement from people we care, we trust? Well, in relationships, often our word is good enough, but in the Healthcare industry, “if it’s not documented, it didn’t happen” therefore we must establish documentation, and the appropriate approvals by the relevant stakeholders, for process validation.

 

Process Control – signs, signals and trends

As with all relationship we look for signs, signals and trends for the very hint of trouble in a relationship. We look for process data and control charts (a control plan) for these signs, signals and trends to tell us that very hint of trouble in a process. Sometimes it does not matter, sometime it does. In our minds, aren’t we already hard at work calculating the possibilities whether there is a need to address them, and once again re-assure our commitment, to ensure  a healthy, long term relationship, or process?

 

 

What does this all mean?

It goes to show how much each and every one of us – not just quality professionals, or engineers, or managers – innately understand the concept of process validation, through our daily dealings with human relationships.

If we understand and appreciate the recipe for success of a successful relationship, we would understand and appreciate the intent of process validation, its steps and requirements, and to treat your process as committed as you would in any human relationship.

So, whether it’s for your life or for your process, remember this:

  • Have a known way – by means of a document – to describe this validation process
  • Have a plan to carry out this validation
  • Establish your input requirements – know what you’re looking for.
  • Always communicate, and have mutual agreement – your documentation approvals
  • Tick the boxes – perform IQ
  • Find your limits – perform OQ
  • Ensure it is consistently capable of meeting what you’re looking for, time and time again – perform PQ
  • Try to integrate the worst case process limits in your PQ to add value to your validation.
  • Understand that circumstances and environment will always vary – assess accordingly and be prepared to re-assure through re-validation
  • Pay attention to the signs, signals and trends, and revalidate as necessary, to ensure a peace of mind.

Thank you, Mom.

 

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