written by Maree Stuart
Getting the basics right
I’m sure if someone asked you what did “Quality” entail, you’d have a list of things that are done.
Some of those things might be drawn from topics and requirements that appear in Standards like ISO 17025, ISO 15189, ISO 17020 and ISO 9001. Some of them might be from things you’ve learned along the way.
According to the American Society for Quality website a quality management system (QMS) is defined as:
‘…a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. A QMS helps coordinate and direct an organization’s activities to meet customer and regulatory requirements and improve its effectiveness and efficiency on a continuous basis.’
Translated into plain English, a QMS brings your business ‘stuff’ together in an efficient and effective package. This means that you’ll continue to meet your customers’ needs, even if the customer doesn’t quite know what their needs are.
Consistency is critical
One of the key factors that helps any organization to meet customer’s needs is Consistency. When you visit the local barista to get your daily caffeine dose, you want that dose to be hitting the spot every time. The barista might not have a certified QMS, but that doesn’t mean they don’t have a system in place to ensure that you consistently get that perfect brew.
Having a system operated by competent people and reliable equipment is a critical part of delivering consistency.
By a “Quality process” we mean everything that goes towards delivery of“Quality”. The thing is, the concept of quality is pretty subjective and transient. What it means to one person in one sector at any one time can differ between people and over time.
Quality can have two meanings:
1) the characteristics of a product or service that bear on its ability to satisfy stated or implied needs;
2) a product or service free of deficiencies
Sometimes the recognition of what is covered in the set of quality processes in an organistion can be difficult. But ISO standards and other quality frameworks can help identify these.
The important thing to realise, is that they are all processes that are going on in the ecosystem that is your organisation. The effectiveness of the organisation’s processes can be determined through a range of quality control and quality assurance activities.
Quality Control vs Quality Assurance
Sometimes, it’s easy for people to get these confused. That’s often because they are put together as one term, “QA/QC”. There is a difference! And they work together like cogs in a wheel.
Luckily, in a lab setting, people are a little more familiar with the differences.
Quality control is the part of quality management focused on fulfilling quality requirements.
In a lab setting, some of the quality requirements are derived from the performance of a test or calibration method. These requirements include when duplicate samples will be tested and by how much test results from duplicate samples can differ. Or it may be a requirement to test a standard sample and the minimum or maximum value for recovery or accuracy from testing or calibrating those samples.
In a manufacturing setting, final products are subjected to QC testing, which shows whether or not the attributes of the product fall within the specifications.
Quality assurance is the part of quality management focused on providing confidence that quality requirements will be fulfilled. That’s all the other “stuff” we do to give us confidence that those quality requirements will be fulfilled.
These other activities include:
- Getting feedback from customers, ie processes for checking that we have met the customer’s requirements;
- Complaint handling processes, so that when something has gone wrong, we ca discover why and prevent it from happening again;
- Non-conformance and corrective action processes, which allow an organization to fix problems, whether they have been identified internally, or have walked out the door and showed themselves through a customer complaint;
- Having criteria for competence, applying those criteria and monitoring if staff continue to remain competent;
- Proficiency testing / interlaboratory comparison program participation;
- Reviewing what customers have asked us to do, and when they want the work completed, before work is even started so we can be sure we can meet their needs and expectations.
Data and evidence
One of the key foundations on which the Quality movement was built was the importance of data and evidence upon which sound decisions can be made.
If you’re doing quality control and quality assurance activities, then these are a great source of that data! Sometimes there is so much data that’s it’s overwhelming to know where to start, let alone analyse it!
That analysis can be well worth the effort. It can uncover something that is lurking in the shadows, ready to pounce (probably just in time for a visit from an external auditor)!
What are some of these analysis tools that can be used?
- Control charts with application of the Shewhart rules
- Pareto charts
- Root cause analysis techniques
- Risks (and opportunities) analysis
- Evaluation of data for trends and patterns. (Humans are actually remarkably good at this task!)
Once the data is analysed, then decision makers (usually managers) can make informed decisions. Without it, it’s like taking a shot in the dark.
How can we help?
We can support your business plans by fine-tuning the system you have in place or creating an effective, efficient system specifically for you.
Call Maree on 0411 540 709 for a confidential, obligation free discussion on how we can support your business to work better and smarter. Or email your questions to firstname.lastname@example.org
You don’t have to do this alone!
Download the article Quality in the Spotlight