1.1 Mission

​​​​​​​​​​​​A. Background & Definitions

According to the EQIPD Quality System's Implementation Strategy, the first step taken by the 1.5.2.3 Process owner is to prepare a statement explaining why they have chosen to implement a Quality System. It is expected that this decision will raise questions, not only from members of their own research unit but also from colleagues, collaborators, advisors, and other stakeholders. Therefore, the Process Owner should be ready to present a clear and compelling rationale that justifies the time and effort required to implement and maintain the Quality System.

In EQIPD terms, this statement is referred to as the mission statement which is a concise summary of why quality is important to the research unit. For more on how EQIPD defines quality, and for examples of how researchers from various sectors answer the question "why quality matters," please visit the EQIPD Quality System page.

EQIPD stresses that the effectiveness of the mission statement lies not in its length, but in its clarity and its ability to be understood and embraced by all members of the research unit.

This Toolbox item relates to one of the Core Requirements (Core Requirement 3 – "The research unit must have defined quality objectives").

B. Guidance & Expectations

The mission statement may have the following three sections:

1. General statement about research data quality

• Define what quality means in your environment or context.
• Determine which quality aspects matter the most in your research, and which of them should be addressed in priority.
• ​State the goal of your research unit or parent organization with regard to research quality.

This statement should briefly describe your understanding of the term research quality. Since interpretations of research quality may vary depending on the organizational context, your focus might differ from that of others. For example, you may emphasize aspects such as data accurately representing the population, implementing measures to reduce bias, or providing adequate training.

Depending on your setting, it is advisable to approach this as a group exercise. In a CRO or biopharmaceutical company, it can be done together with leadership; in academia, it may involve all group members, including students.

2. What is at stake when research quality is not maintained

• Describe the potential consequences of non-compliance or inferior quality for your research unit and/or parent organization.
• Identify and highlight the biggest risks for non-compliance or inferior quality in your environment.
• List specific measures to be taken to address these risks.

Everyone in the research unit should understand and be aware of the consequences of not maintaining research quality. It must be clear what the potential impact can be if individual team members do not contribute to generating high-quality research data. This description should outline the key consequences—both for the research unit as a whole and for individual researchers. In this context, it is also advisable to identify measures that can help protect the research unit from negative outcomes.

3. Quality objectives

• Describe what exactly the Quality System shall improve in your research unit and/or parent organization.
• Define the specific, measurable and traceable goals that your research unit and/or parent organization wants to achieve with the EQIPD Quality System.
• Provide indicators for each objective and describe how you will use them.

A description of improvements may focus on the research process itself, such as experimental design, data analysis, or reporting. However, it can also include supporting processes like the storage of research materials, documentation of research data, or archiving practices. It is important to identify and describe the areas where your research unit has the most pressing needs. While defining measurable goals can be challenging, it is highly recommended, as such goals help assess the long-term effectiveness of the implemented measures.

PLEASE DO NOT FORGET

• ​​To make sure that an incentive and award/reward structure is aligned with the quality objectives (please refer to items 1.3.1-1.3.4 for more information). The following questions serve as examples of how such an alignment can be tested:
  • Do we encourage / support publication of "negative" or "null" results, i.e., findings that are different from those expected?
  • Do we recognize / reward high-quality studies irrespective of the outcome ("positive" or "negative/null" results)?
  • Do we encourage people to develop and implement risk-mitigating strategies and procedures? Do we recognize these efforts?
  • Do we encourage people not to rush experiments but to invest time and resources in developing/using robust methods, optimizing experimental set-ups and to conduct experiments properly according to high-quality standards (even if it takes more time than initially allocated)?​
  • Do we review internal processes to make sure that there is no pressure to generate "positive results"? If there is such pressure, do we have processes to mitigate the risks?
  • When hiring new people, do we consider the quality and rigor of the applicants’ research?​

C. Resources

Template to create a Mission Statement based on the above guidance - [1]

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