Basic controls for R&D
Establish a risk-based quality system for R&D work that is designed to control what needs to be controlled, rather than to set controls just for the sake of setting controls.
Establish a quality system in which the levels of control increase as a product progresses through the development phases.
Institute appropriate documentation practices that provide flexibility for scientists but result in a complete and accurate history of purpose and scope of work; how the work was performed; where the work was performed and by whom; and observations, results, or conclusions.
Establish mechanisms whereby related pieces of work can be linked or cross-referenced so that the story of product development can be assembled efficiently.
Basic controls for projects.
Develop and follow an experimental plan (part of a project plan) that sets forth the specific types of controls deemed appropriate according to the purpose and scope of the work that is planned.
Establish appropriate controls over known sources of variability including:
PeopleEstablish procedures describing how work should be performed. These procedures may be presented in memoranda, protocols, SOPs, or other forms of documentation. Provide training, instructions, or demonstrations for employees to ensure that procedures are interpreted and will be followed correctly and consistently. It is particularly important to ensure that technique-based skills (e.g., pipetting) are consistently applied. Do not assume that individuals with equivalent years of education and experience will perform critical functions or interpret instructions in the same manner.
EquipmentUse clean or new equipment, accessories, and other labware; use instruments that are in good working order and calibrated; specify as many equipment operating conditions as possible and document the actual conditions used or observed.
MethodologyDescribe analytical methods and manufacturing instructions as thoroughly and specifically as possible.
Samples and other materialsDescribe and characterize samples, controls, and ingredients in manufactured products according to the scope and purpose of the work. At a minimum there should be a record describing: source, appearance, storage, and handling conditions. As development progresses, and specifications are developed, further testing and characterization is expected.
Applying these simple principles and recommendations will improve the quality of R&D work, add credibility and validity to study results, and help to streamline the product development process.