Quality ASAP

Learning Bite:Quality ASAP

Tips on how to build a QMS that works for you.

START

What is Quality ASAP

The Challenge

Think SMART

Summary

Quiz

Objectives

Objectives

In this short interactive course, we will look at how you can think SMART and build a QMS that works for you. We will summarise:

• The challenges faced when building a QMS

• The Quality ASAP approach

• How to think SMART

Unit 1: The Challenges

Unit 1: The Challenge

QMS: The Challenge

The Quality Management System (QMS) is the mechanism companies of any size can rely on to demonstrate the control of their operations and that their products can be relied upon. Organisations vary wildly though and those procedures from your last company may not be the best approach for the new one. We’ve often seen that existing Standard Operating Procedure (SOP) that meets the requirements but, it requires four signatures, and they forget there are only three people working at the company. Does somebody wear two hats, and sign twice? Why? Do we ask why often enough? We need a system that meets the requirements but doesn’t tie us in knots. We need to build a compliant system that works for you but is not restrictive or burdensome.

Unit 1: The Challenge

People view a QMS as complex and difficult. Building it can seem daunting, but it does not need to be gold-plated with bells and whistles and coverage for every single situation that may potentially occur. It should be future-proof so it can grow with the organisation. Taking the example of GLP, you may not be GLP just now but may want to join the programme in the future. Therefore build your system with that in mind, but don't build a fully GLP-compliant system from the start. It is also important to note that one size does not fit all; what works for one company, may not work for you.

Unit 1: The Challenge

How do we do that in regulatory and non-regulatory environments?

Where should you expend the most of your energy to get the greatest benefit of either building a system from the ground up, or being able to rethink it and strip it right down?

What do you need to think about?

Example

Example

Example

Quality is never an accident.It is always the effort of intelligenteffort.

john ruskin

Unit 2: What is Quality ASAP?

Unit 2: What is Quality ASAP?

Quality ASAP

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A

ACCURATE

S

SIMPLE

A

AGILE

P

PRAGMATIC

Unit 2: What is Quality ASAP?

Accurate

Know your target (GLP, GCP, GMP, ISO, Control) and know your scope. Are you covering your whole global organisation, or only looking at your one lab? Make sure any required components are included.

• What are your services?​

• Who are your customers?​

• What regulations do you need to meet? ​

• Are the regulations applicable?

Unit 2: What is Quality ASAP?

Simple

Don't overcomplicate solutions. Don't write SOPs that cover every single potential scenario - if it only happens 1% of the time, it's not the standard. Systems that are onerous to operate or not designed for your organisation are unlikely to be successful.

• Why write a twenty-page SOP if a flow chart will cover it

• Electronic systems have their place but is £20k the right investment now for a three-person company when you are all onsite

Unit 2: What is Quality ASAP?

Agile

Don’t reinvent the wheel, deliver what is needed now and allow for continuous improvement and growth. If you suspect your client base will need GxP in future, your system should be agile enough to adjust and add components without needing to be re-started from scratch. Consider…

• Harmonising where possible

• Leveraging what you need from what you have​

• Reassessing in six months

Unit 2: What is Quality ASAP?

Pragmatic

Real systems and real people need real solutions. Keep it focused on what it is that you need the system to be doing right now, in the way that your organisation needs it to be delivered.

• It has worked before – was that a global organisation with hundreds rather than a spin-out of ten people?

• GMP controls are not appropriate for early-phase R&D or GLP

Unit 3: Think SMART

Unit 3: Think SMART

Think SMART

Don't expect a QA person to build the SOPs for your entire company. Get the right people involved and allocate tasks appropriately then you understand that it isn't as big as you thought it was. When targeting the completion of your QMS: think SMART.

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measureable

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ACHIEVABLE

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RELEVANT

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SPECIFIC

TIMEBOUND

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Your goal should be clear and specific, otherwise you won't be able to focus your efforts or feel truly motivated to achieve it. Ask yourself the following: What do I want to accomplish? Why is this goal important? Who is involved? Where is it located? Which resources or limits are involved?

It's important to have measurable goals, so that you can track your progress and stay motivated. Assessing progress helps you to stay focused, meet your deadlines, and feel the excitement of getting closer to achieving your goal.

Your goal also needs to be realistic and achievable to be successful. When you set an achievable goal, you may be able to identify previously overlooked opportunities or resources that can bring you closer to it.

This step is about ensuring that your goal matters to you, and that it also aligns with other relevant goals. We all need support and assistance in achieving our goals, but it's important to retain control over them. So, make sure that your plans drive everyone forward, but that you're still responsible for achieving your own goal.

Every goal needs to be time-bound, so that you have a deadline to focus on and something to work toward. This part of the SMART goal criteria helps to prevent everyday tasks from taking priority over your longer-term goals.

SMART is an acronym that you can use to guide your goal setting to ensure that your goals are clear and reachable. Its criteria are commonly attributed to Peter Drucker's Management by Objectives concept.

Unit 2: What is Quality ASAP?

Things to Consider

• Is someone responsible for keeping it on track, for making sure progress is being made as desired​?

As building a QMS is a significant project and not immediately revenue-generating, things tend to slip, so it is important to consider:

• Who is driving and monitoring the project?​

• Do they have the support to get things done?​

• One person can’t write all procedures, SME input is required,

• If there is limited resource, can it be done before the work that needs it comes in?​

• Have realistic goals been set?​

Unit 3: Think SMART

Things to Consider (cont...)

Has the right homework been done?​

Are you eligible for the regulations you want to claim?

Targets and deadlines need to be realistic because either quality is important and resource needs to be dedicated to this, or quality is not important.

Unit 4: Summary

Unit 4: Summary

Know your target (GLP, GCP, GMP, ISO, Control) and know your scope (site, lab).

Summary

QUALITY ASAP

Accurate

Simple

Agile

Pragmatic

Deliver whtat is needed and allow for continuous improvement

Do not provide overly-elaborate or complicated solutions

Real solutions for real situations. It's got to be manageable.

Unit 4: Summary

Start at the beginning and do the right thing from the outset. Plan and control it but don't be afraid to review and change it and don't be afraid to admit that you started one way but it's not the right path. In short, it may not be revenue-generating now, but it can add significant value to the business going forward.

Do what works for you; understand what you're doing and why you're doing it and just because it’s always been done that way, or it worked for you before doesn’t mean it’s the right solution this time.

shona ross, head of qa at towermains

QUIZ

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Quiz

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Congratulations!

If you'd like to find out more about Quality ASAPand how Tower Mains can help you withyour QMS needs, please contact info@towermains.com.