1.1 Mission

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

According to the EQIPD Quality System's Implementation Strategy, the first thing that the 1.5.2.3 Process owner does is to prepare a statement explaining why she / he has decided to implement a Quality System. It is expected that questions will be asked, not only by the members of her / his research unit but also by other colleagues, collaborators, advisors and other stakeholders. Thus, the Process Owner should be prepared to provide a compelling rationale to justify the efforts and time that will be invested in the implementation and maintenance of the Quality System.

In EQIPD terms, the mission statement is a concise summary of why quality matters for the research unit. Please visit the EQIPD Quality System page for information on how EQIPD defines quality and examples of how scientists from different sectors answer the question "why quality matters".

EQIPD emphasizes not the length of the mission statement but its ability to be understood and endorsed by all members of the research unit.

This Toolbox item refers 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 shall briefly describe your understanding of the term research quality. Since this understanding might vary depending on the context of your organization, you might have a different focus compared to others (e.g., data points being an accurate representation of the population, having implemented measures against bias or providing adequate training). Depending on your setting, it is advisable to see this as an exercise within a larger group; e.g., within a CRO or a biopharmaceutical company it can be done together with leadership or in academia with 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.

The understanding and awareness of the consequences of not maintaining research quality should be known to everyone in the research unit. It should be clear what the impact can be if each team member is not working to generate high-quality research data. This description should point out most, if not all, consequences for the research unit but also for the individual researcher. In this context it is also advisable to identify measures to protect the research unit against the negative impact.

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 can be about the research process itself such as experimental design, data analysis and reporting. But it can also be about the supplementary processes such as storage of research materials, the documentation of research data or the archiving thereof. It is important to identify and describe these aspects for which your research unit has the greatest need. Finding measurable goals is difficult but advisable, since they will help assess the effectiveness of the implemented measures over the years.​

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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