Quality is Everyone’s Job

Quality is Everyone’s Job

Kari Miller, Senior Director of Industry Solutions and Product Management, Pilgrim Quality Solutions

Vision, values, goals and strategy are the guiding principles of a corporation and culture culminates from them. Quality culture refers to the complete awareness, commitment, attitude, and behavior of the organization with respect to quality.  Corporate leadership must effectively communicate and more importantly demonstrate quality as an inherent value of the organization.

Look at Toyota, the poster child of a quality culture.  Everyone in the organization accepted responsibility for quality; this was demonstrated and communicated at all levels in the organization.  In the 1990s however, the company’s goals changed; its number one priority became growth.  Its new goal: to become the world’s largest automotive company.

This shift meant that employees weren’t focused on quality as they once were, and defects went either undetected or unreported, resulting in the 2009 recall of 9 million vehicles, costing billions of dollars.  Toyota’s growth culture replaced its quality first, continuous improvement culture.

Toyota, however, isn’t alone. In today’s economy, everyone is expected to do more with less which may seem diametrically opposed to a quality culture, but it isn’t.  Organizations that embrace quality by putting the customer first and by striving for continual improvement will be able to do more with less while delivering quality.

Continual improvement starts with a focus on process and process improvement, and it involves everyone in the value chain (company, vendors and customers).  Four key assumptions must be embraced if an organization is to focus on process improvement and live a quality culture:

  1. There is a root cause for each defect.
  2. Defects are preventable.
  3. It is better to prevent than correct defects.
  4. Inspection/testing can be reduced for capable processes.

Quality initiatives commonly deployed in an organization to focus on process improvement may include, but are not limited to

  • Six Sigma
  • TQM
  • Lean Manufacturing
  • Design Controls

Companies embracing quality initiatives may also deploy guidelines and standards such as GxP and ISO9000/9001. All of these elements are critical to process improvement.

However, as the four key assumptions imply, the processes and procedures that need to be well documented, understood, deployed and effective are those that determine the root cause of defects that do occur and prevent them in the first place.  Therefore, best practice nonconformance (NC) reporting, Corrective and Preventive Action (CAPA) and complaint management must be in place and in use across the organization, not just in the QA department.

Improvement activities can fail for a number of reasons. Organizations may have extensive quality control measures in place, but not everyone lives and breathes them.  Quality has not become a natural part of the culture. With the competitive pressures of the economy today, companies cannot afford to have anything but the very best quality. In an action-oriented quality culture, this attitude and willingness must be developed among everyone if the organization is to thrive.

With quality being the job of everyone, information about the company’s sales, customer needs, orders, finances, delivery of parts, productivity, efficiency, the activities of different people and teams, and how one team affects another, are vital.  Employees make decisions about what to do based on information. Limited information means that decisions will not be made based on facts and therefore are more likely to introduce uncertainty into the organization and its processes.

Clearly documented processes and procedures, regular training and educational sessions are also important tools in keeping employee’s informed, ensuring factual decision making and teamwork.

Kari Miller

Regulatory & Product Management Leader, IQVIA Quality Compliance