7 Keys To Establishing A Quality Culture Your Senior Management Will Love
By Christine Park, Quality Architech
Executive Management participation and support is key to the successful development, implementation, and management of pharmaceutical quality systems. The FDA guidance document (Quality Systems Approach to Pharmaceutical CGMP Regulations) defines the expectations for management with executive responsibility (MWER). These expectations for MWER are aligned with the Q10 Guideline, published by International Conference for Harmonization (ICH).
Bottom line: Executive management has the responsibility and authority to assure compliance to the quality system and appropriate regulations for your product. MWER are those individuals who have ultimate responsibility for the quality of the product, as well as providing overall support and management of the business. These are usually the most senior executives in the organization. One of the most important responsibilities and activities to drive compliance is to develop and support a strong quality culture within the organization!
We all know that establishing or changing the culture within an organization is very difficult and requires strong leadership skills from the entire executive management team. As the QA manager or QA staff, you will need to influence the executive management commitment to provide strong quality culture.
As the quality assurance manager, it is critical that you understand these expectations, as well as the role and responsibilities of the executive management team. You will be expected to provide guidance and support to assure the quality system meets the regulations and compliance requirements.
Let’s take a look at some of the basic expectations and requirements related to leadership that the executive management team (and you as the QA manager) should consider as part of the quality system implementation. Here are some recommendations I have used during my career to be personally successful, as well as to achieve success and compliance for the executive management team.
Recommendations For Success For The QA Manager
1 – Quality is really just good business!
- Designing quality into the product development and manufacturing processes, rather than inspecting quality into the product, reduces scrap and non-added value work, thus providing high-quality products at lower costs.
- Integrating and aligning the quality system plan with the other strategic business plans will drive this business success.
- In addition, providing meaningful metrics demonstrating how the systems approach can reduce cost and increase quality can create a compelling story for the executive management team.
I find positing quality with this approach much more effective than focusing on fear of potential FDA action for noncompliance.
2 – Provide guidance on the wording of a quality policy to support the business and executive vision.
The quality policy must demonstrate the management vision and commitment to quality and compliance. It must have meaning, and resonate throughout the entire organization; calling them to action to do it right the first time. Linking the quality policy to the business objectives and goals provides Executive Management the tools to keep their finger on the pulse of the operations and drives business success.
3 – Don’t expect everyone in the organization to be a quality and/or compliance expert.
Memorizing the regulations or laws doesn’t really help them do their job any more effectively. I often use the saying, “It’s your job to do your job and document what you do. It is my job (as the quality manager) to ensure what you do meets the requirements of the regulations.” This allows employees to focus on their job and manufacture good quality product, rather than memorizing regulations. You will be surprised at how much more cooperation you can get with this approach.
4 – The members of the quality unit should be independent of any other function within the organization, and report directly to executive management.
- The quality unit has the responsibility to assure products are properly released in accordance with regulations.
- They should not have to police the other functions to assure there is an appropriate focus on quality and compliance.
- There should be an appropriate escalation system to resolve any conflicts and/or issues that may develop between organizations related to quality.
As the quality manager, you should ensure your management team understands all sides of key decisions from an objective (yet compliant) perspective. Rather than say “No, it’s against the regulations,” take the time to understand the situation and look to the guidance documents and other resources for potential solutions to obtain a win-win-win outcome.
5 – Make the quality manual simple and meaningful. It should reflect how the organization meets the regulations to ensure compliance.
The quality manual is not just a regurgitation of the regulations and guidance documents. It is the company interpretation of the regulations and references to the other lower level documents and procedures. The integration of quality with business strategy and plans can assure continued regulatory compliance without the penalty of the cost of poor quality. If you use this approach to the quality manual, it becomes a valuable tool for executive management, as they have something easy to follow and explain when being interviewed by the agency or other regulatory bodies.
6 – Keep the procedures simple and clear.
- Right-size the documentation you need to fit your organization and scope of work.
- Define the differences between various types of documents that you need to support your quality system activities and processes. (E.g. policy, procedure, process, work instruction).
- Do not make procedures and documents overly prescriptive and difficult for the employees to follow. Identify those activities that are critical to quality (either process or product), and ensure employees understand why they are doing something a specific way.
7 – Have meaningful management reviews.
The data presented should tell a story. Executive management should be able to determine what is happening in key areas of the business from the data presented. I once sat through a management review that presented 300+ Powerpoint slides over 8 hours. The slides were pretty, but there was no action or explanation of what the data was showing. A discussion with executive management after that meeting revealed everyone thought it was a waste of time. Working with the quality unit and the other functional management, we modified the review and focused on the areas that were critical to the management team, and received much greater support to initiate change.
Over the next few articles, I will be delving deeper into specific areas of the quality system mentioned above. Remember, you can have influence with the executive management team, as well as all areas of the organization. The key is for you to completely understand the business and fit the daily operations into the regulations. Keep it simple, while keeping it relevant. Your ability to educate the executive management team, while providing practical and pragmatic solutions, will enable you to become a valued and respected member of the management team.
*Please note: While this article is targeted at the Pharmaceutical Quality System, the principles are applicable in the Medical Device, Biologics and other regulated industries.
Source: Quality Architech
