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The QA Pharm

Quality Insider

Who Owns the Quality System?

When ownership behaviors are expected and nurtured, awesome things happen.

Published: Wednesday, January 5, 2011 - 08:43


understand on a philosophical level that everyone owns “quality.” Much like safety, everyone has responsibility for following safe practices and calling attention to potentially unsafe conditions. However, there are also safety departments responsible for establishing safety policies and procedures, as well as conducting periodic safety inspections. They also report safety metrics such as “OSHA reportable” incidents and near misses. Members of the safety department keep current with the latest safety equipment, changes in the regulations, and benchmark against best industry practice. Management takes these reports and metrics quite seriously, because it is ultimately responsible for ensuring a safe work environment.

This is fairly analogous to a quality management system (QMS). Everyone has personal responsibility for following current good manufacturing practices (CGMPs) in general and procedures in particular. The quality assurance department is responsible for establishing and measuring the effectiveness of the QMS. It periodically conducts internal audits and reports quality system performance metrics. The findings are reported to management, because it is ultimately responsible for ensuring that products are manufactured in a state of control and in accordance with CGMP regulations.

But allow me to break away from generalities and get very specific, because it is in the specifics where I believe the QMS falls apart in practice. It has to do with the notion of “ownership” and having a person—by name—for each element of the QMS who “owns” that particular element and exhibits defined “ownership behavior.”

In my opinion, creating an environment where ownership behaviors are defined and expected is a powerful part of a compliance sustainability strategy.

What are some ownership behaviors? Take these for example:

Own the (system) procedure. The owner is responsible for ensuring that the procedure(s) his particular element of the QMS remains current with regulatory expectations and best industry practice. The owner does not wait for negative feedback from a regulatory agency or corporate audit to identify the problems or to be motivated to improve to the system. For example, the owner is the first to know that an identity test is required for each drum of active ingredient and is the driver to ensure that the procedure is changed.

Own the implementation. The owner is responsible for ensuring that the particular element of the system is deployed. It is in the owner’s best interest to know that all the employees required to be trained on the procedure have been identified, and the procedure is incorporated in the employee’s curriculum. For example, the owner of the complaint-handling system ensures that anyone who could possibly receive a product complaint has been trained. It would not be unusual for the owner to conduct the training as the subject-matter expert. In fact, the collective owners in the company should be the focus of a “train the trainer” program.

Own the performance metrics. The owner is responsible for identifying the best possible performance metrics that would indicate how well the system is being managed, as well as what problems the system is detecting. It is the owner who first detects an unacceptable trend and calls it to management attention. It will be the owner who presents the system metrics to the management review forum. For example, it is the owner of the corrective and preventive action (CAPA) system who reports to management about the significant backlog and the associate regulatory and product quality risk.

Own the recommendation. The owner is responsible for knowing what the solution to the problem is. She will have consulted with the users of the system to understand implementation issues and identify targeted action to address the problem. When the owner presents metrics to the management review forum, recommendations are suggested. In many cases, it will not be necessary for management approval to proceed with the solution. For example, it is the owner of the preventive maintenance (PM) system who first detected the backlog but has also determined with the production manager that an integrated PM and production schedule is required. So they just do it and inform management.

Own the knowledge. The owner is the subject-matter expert (SME). The company has supported continuing education for the owner to ensure that he remains current in the field. The owner takes the initiative to identify educational opportunities. When companies cut back on the training budget, they certainly want to “red circle” the owners to ensure that they are exempt from the budget cut. The owner shares the knowledge to continually raise the competency bar. The owner is the person who represents the system for problem solving, as well as addresses questions during regulatory inspections.

“Ownership” does not imply isolation or autonomy. But in this world of managing business and decision-making through teams and consensus, “ownership” and personal accountability tend to get lost or totally diffuse.

Just imagine the organization’s strength if ownership behaviors were expected and nurtured within an operating site, as well as across the company sites.

Just imagine the framework for continuous improvement at the site and company network levels to turn owners loose to drive best compliant practices.

Your assignment:

• Make a list of the elements of your quality system (e.g., deviations, CAPA, batch record review, and incoming inspections) and enter the name of each owner
• Develop a strategic plan to support and enhance ownership behaviors


Watch awesome things happen!


About The Author

The QA Pharm’s picture

The QA Pharm

The QA Pharm is a service of John Snyder & Co. Inc., provider of consulting services to FDA-regulated companies to build quality management systems and develop corrective actions that address regulatory compliance observations and communication strategies to protect against enforcement action. John E. Snyder worked at the lab bench, on the management board, and as an observer of the pharmaceutical industry for more than 30 years. His posts on The QA Pharm blog are straight talk about the challenges faced by company management and internal quality professionals. Synder is the author of Murder for Diversion (Jacob Blake Pharma Mystery Series Book 1).


Obvious & Simple, but Missed

An obvious and simple point that is altogether missed in organizations: assign ownership to a system element for increased performance in multiple dimensions e.g. employee engagement & empowerment, compliance to standards & regulations, identifying opportunities for improvement, etc.

I will be circulating this article for my colleagues to consider how we plan and work.

Shrikant Kalegaonkar
twitter: shrikale