Quality Assurance/Quality Control (QA/QC)

Quality assurance and quality control refer to the actions performed to ensure the quality of a service, product or process.

Quality Assurance

Part of quality management focused on providing confidence that quality requirements will be fulfilled. (Process oriented)

Quality Control

Part of quality management focused on fulfilling quality requirements. (Product oriented)

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Quality Assurance vs. Quality Control

Quality control and quality assurance are two interrelated aspects of quality management that set the foundation for Quality Management Systems (QMS). ISO 9000 standards provide guidance and tools for companies and organizations who want to ensure that their products and services consistently meet customer’s requirements, and that quality is consistently improved.

Quality Management System (QMS)

Maintaining consistent quality while preventing mistakes and defects is made easier with technology. Quality management systems are available for small, medium and large companies. Easily meeting regulations accurately and efficiently depends on implementing the right QMS.

Online Quality Management Systems

Online QMS systems allow you to keep your information up to date with real-time statistics. Collaborate online with colleagues, customers and suppliers. Connect your documents, action items, training and more with email alerts. Tracking, accessing and maintaining your organization’s quality processes with an online QMS give you greater flexibility. Many of these QMS systems offer your organization flexibility on where the system is hosted.

Cloud-Based

A cloud-based QMS is accessible using a web browser that has connectivity. This is a vendor-hosted solution in which the vendor is providing server access.

On-Premise

An on-premise QMS is accessible using a web browser that has connectivity. This is a customer-hosted solution in which the customer is providing server access.

Quality Control Automation

It can be difficult to quantify the amount of time and money that goes into running an effective quality management system. There are many costs that go into it. You have the hard labor costs of managing the quality records in your system (e.g. corrective actions, nonconforming products, customer complaints, training records, calibration records, etc.), cost in poor quality, cost in business interruption for audits and audit follow up, cost in consulting, and even the cost of your registration to ISO, FDA, or other regulatory body. The way your quality control system is managed can deeply impact those costs.

Quality Control and Quality Automation

Quality Management Systems Hierarchy

What type of quality management system do you have?

Type 1

100% Paper system – no software

Type 2

Hybrid system of MS Excel/Word

Type 3

Multiple “island” software packages

Type 4

Fully integrated eQMS software solution

Examples of Quality System Types

Level 1 QMS

  • Paper, Paper, Paper
  • Binders

Level 2 QMS

  • Excel Sheets with Hyper linking
  • Individual Custom MS Access or Lotus Notes database
  • Word Documents
  • Paper routing

Level 3 QMS

  • Gage Pack/Gage Track
  • Documention
  • Custom SharePoint
  • Wiki

Level 4 QMS

  • QT9™ QMS
  • ETQ
  • Intelex
  • Master Control

Quality System Types Pros and Cons

All of these quality systems have their pros and cons. The point of an effective quality management system is to be as efficient as possible and to save as much money in poor quality - not all poor quality is measured in nonconforming product. That being said document control, a solid customer feedback or complaint system, and an effective training system all chip in to ensure all parts of your organization to ensure ultimate quality in product and service.

Without them all working together, your system is bound to break down sooner or later costing your company more money and potentially damaging customer relationships. So even though your manual or hybrid system seems to be chugging along, your company is probably spending too much money or labor to run it/maintain it or you are missing some valuable tools to help continually improve it. General pros and cons to the different levels of a quality management system below.

Type 1 QMS Pros & Cons

100% paper-based system. No software.

Pros

  • Maintain ISO Certification

Cons

  • Usually has 1 person that runs whole QMS
  • Adds way too much work to an already existing position
  • If that person moves on, organization is generally put in a bad position trying to replace that person and keep QMS working
  • Too many opportunities for issues/items to “fall through the cracks” (human error)
  • Difficult to extract any measurable data in a reasonable time
  • Difficult to know status of issues at any given time
  • Hard to keep everyone on task when paper can be buried on a desk

Type 2 QMS Pros & Cons

Hybrid system of MS Excel/Word and paper

Pros

  • Maintain ISO Certification
  • Can cut down on paper in system for logs and certain electronic forms

Cons

  • Usually has 1 person that runs whole QMS
  • Adds way too much work to an already existing position
  • If that person moves on, organization is generally put in a bad position trying to replace that person and keep QMS working
  • Too many opportunities for issues/items to “fall through the cracks” (human error)
  • Difficult to extract any measurable data in a reasonable time
  • Difficult to know status of issues at any given time
  • Hard to keep everyone on task when paper can be buried on a desk

Type 3 QMS Pros & Cons

Hybrid system of MS Excel/Word and paper.

Pros

  • Maintain ISO Certification
  • Can cut down on paper in system for logs and certain electronic forms
  • Brings a level of automation to certain tasks essential to QMS such as document control or calibration

Cons

  • Software does not talk to each other which leads to double work at times and opens the door to human error.
  • Difficult to know status of issues at any given time
  • Very expensive as all separate software packages can be pretty expensive if bought individually

Type 4 QMS Pros & Cons

Fully integrated eQMS software solution.

Pros

  • Maintain ISO Certification
  • Eliminates 95% of all paper used in QMS
  • Automates all necessary components to ISO certification and quality in general
  • Spreads out the responsibility of an organization’s QMS keeping everyone accountable for the organization’s quality.
  • Interconnectivity of software modules makes QMS functions efficient and cuts out human error.
  • Easy to pull out measurable data for all aspects of QMS
  • Makes internal and 3rd party audits more efficient

Cons

  • Can be cost prohibitive depending on what software purchased
  • Implementation can cost money through supplier, or can be a long process

About QT9

QT9 Software specializes in quality management software and ERP job management software that automates workflow and synchronizes company information, so clients can easily connect and collaborate with colleagues, customers and suppliers. With more than 300 clients and 100K users, QT9 Software Inc. is modernizing quality management and manufacturing processes for small, medium and large companies. QT9’s user-friendly platform helps clients optimize efficiencies and ensure regulatory compliance (e.g., ISO Compliance, Aerospace/Automotive Compliance, Food Compliance and Medical/Pharma Compliance). QT9’s intuitive solutions are easily scalable and quick to implement. Software validation and annual upgrades are included. For more information visit www.QT9QMS.com or contact us at 866.913.5022.

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