Quality Assurance vs Quality Compliance

While the terms quality assurance and quality compliance or control, are often used interchangeably, there is a significant difference between the two.

If quality compliance is a set of mandatory and non-optional activities that businesses must follow, quality assurance processes are a set of optional activities which can sometimes lead to them being interpreted as ‘extra’ or a ‘luxury’.

Implementing and adhering to quality assurance programmes, on the other hand, remains critical to overall quality control in any organisation.

Whereas quality control is concerned with meeting regulatory requirements, quality assurance is concerned with the quality of service provided by your organisation.

A quality system, in essence, focuses on the continuous improvement at all stages of the product or service life cycle from concept to implementation. This is one reason that compliance alone is not sufficient for businesses to succeed.

For businesses to continuously improve the quality of their products/services, they must implement both quality assurance and compliance. Those that implement a strong quality assurance and compliance programme are the most successful.

Do you consider yourself to be quality-oriented?

Many people’s response is that they are more concerned with compliance. Don’t get me wrong: compliance is still important, but many businesses fall short when it comes to regulations.

What are the real distinctions between quality and compliance?

Mindset of Quality vs. Compliance

Many businesses do not embrace the regulations they have to work to. Instead, they resist them and see them as obstacles getting in the way or slowing them down.

As a result, they end up simply trying to get by, seeking the path of least resistance in order to comply. They have not fully embraced and incorporated the regulations as good business sense.

Companies frequently examine these regulations to “check a box.” They are simply attempting to pass an audit or appease an assessor. From a business perspective, this is passing up numerous opportunities for improvement.

Mindset Differences in Behaviour

Mindset of compliance

Individuals who are concerned with compliance see quality as the responsibility of the quality department only. They see SOPs and Work Instructions as an impediment to doing the job rather than as a source of value to the organisation. From an audit standpoint, they want to check the appropriate boxes and forms to ‘cover’ themselves.

This is a very reactive approach and these businesses tend to create silos between their various functional groups, with each group resisting quality measures. I think we have all worked at places where the QA team are seen as the ‘police’ to be feared and hide things from.

Mindset for excellence

Quality is achieved through a combination of art and science. Of course, compliance remains critical, and we must demonstrate that we are meeting the regulatory requirements. However, the notion that it is solely the responsibility of the quality department is out of date and doesn’t benefit anyone. The most successful companies have adopted the mindset that quality is a cross-functional responsibility, regardless of which department anyone works in.

Part of the mindset is formed dependant on the way a quality system is designed or approached.

It is generally best to Keep It Simple. Start with the most basic version of a policy or procedure possible. It is easier to start simple and develop things (appropriately and only if necessary) over time than it is to start complicated and try to simplify later. Concentrate on the regulations’ intent and the critical question, “Will this benefit the customer?”

The Advantages of True Quality Mindset

First and foremost, you will become more productive. You will be more productive if you understand your role, how it fits into the larger picture of the company, and how your services are received by the customer. You’ll also likely enjoy coming to work and making a difference! When you’re in this mode, you’ll be able to see your impact in terms of how you’re assisting others.

Keeping a Quality mindset for excellence also allows you to be more creative and innovative. You might think that this is the opposite of compliance, but this is not the case. There is always the possibility of finding a better way. A less complicated approach. To work together more.

When quality is embraced throughout the organisation, there will be fewer negative events to address. When there are a lot of complaints about a service, the culture tends to deteriorate quickly. You’re constantly fighting fires, which puts a strain on your business, especially when you have to devote dedicated resources to investigating those complaints. Rework, policy changes, and process changes are examples of downstream noise. When this happens too often, you have a systemic problem and a CAPA (corrective/preventive actions) situation, which requires more resources to resolve.

As a quality-focused company, you will almost certainly have fewer CAPAs because you will be working with a mindset of continuous improvement.

Disconnect Between Companies and Regulatory Bodies

For a long time, there has been a misunderstanding between organisations and regulatory authorities. If you mention an IANZ assessment to some people, they will most likely become tense. It is because of this that inspections can be contentious because businesses believe they are on trial.

It’s a bit like that feeling when you look in your rear-view mirror and notice a police car behind you, your heart rate immediately rises. Isn’t this a natural reaction for most people? Even though you’re not doing anything wrong. Companies frequently see their auditors and assessors like police officers rather than partners.

We need to taka a proactive approach to this and rather than panicking in order to “get ready” for an audit, IANZ or any other authority the should be able to show up at any time and find a “business as usual” situation that meets both quality and compliance standards.

If you change your behaviour because of an impending IANZ assessment, this should be a red flag that you’re not where you should be in terms of quality.

Distinctions Between Quality Assurance and Quality Control

Quality Assurance	Compliance/Control
Aims to avoid defects	Aims to identify and correct them
Ensures that the requested quality is met	The procedure that focuses on meeting the requested quality
Performed during the system development and life cycle	Performed during implementation of the system
Preventative Approach	Corrective Approach
Proactive Measure	Reactive Measure
Determines and defines the standards and processes	Confirms standards and processes are being followed
Primarily to prevent defects in the system – high efficiency	Primarily to identify defects in the system – low efficiency
Verification – ensures processes are executed the right way	Validation – ensures processes are executed as per the requirement
Everyone in the business is responsible	Dedicated QC team responsible
Examples of QA: Internal and External Audits Establishing standards Documentation Project planning	Examples of QC/Compliance: Measurements Inspections Testing Reviewing

Summary

• Both QA and QC are essential parts of quality management. They are related but not identical. Both play crucial roles in maintaining consistent and reliable systems and processes.
• QA and QC work together to ensure that all products and services meet the required standards and ensure customer satisfaction.
• Quality Assurance (QA) and Quality Control (QC) are separate concepts of one system (QMS).
• Quality Assurance is strategic and very process oriented. It’s about understanding what’s required to achieve quality and creating a system to carry out those quality management requirements.
• Quality Control is tactical and quality management focused. It’s the act of monitoring the work as it occurs. QC ensures completion of activities conforms to the expected standards.
• QC also implements corrective measures when those standards aren’t met.
• QC happens on the job and requires the quality managers, inspectors, and contractors to use the QA tools and operational techniques.

Basically, QA is process and QC is the execution. Actively and effectively applying best practices of the two will prevent and address issues before they arise ideally, and at worst, before they become a real problem.

The main goal of the two is to help us fulfil quality requirements with a consistent QMS and provide a blueprint of the QC activities that needed to conduct to prevent issues and/or identify problems.

Both parts – the planning and the execution – are essential to deliver a true quality service.