Quality Planning
What a definition is not
A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.
The systematic process of defining the quality objectives, resources, procedures, and verification points needed for a specific product, project, or process before work begins — commonly documented in a quality plan that identifies which SOPs, specifications, and acceptance criteria apply and where the quality unit must be involved.
Quality planning happens up front, before manufacturing, a validation campaign, or a new product introduction begins. It answers practical questions: which specifications apply, which stages require quality unit sign-off, what sampling and testing plan will be used, and what documentation will be generated as evidence.
For a new product or process, quality planning typically produces a quality plan or project quality plan that maps deliverables (protocols, batch records, specifications) against a timeline and assigns ownership, so gaps are identified while they are still cheap to fix rather than discovered during a pre-approval inspection.
Quality planning is distinct from quality objectives: objectives describe the “what good looks like” targets over time, while quality planning describes the specific activities and controls that will be executed for a defined scope of work.
- —Performed before execution begins, not retrospectively
- —Identifies applicable specifications, procedures, and quality-unit checkpoints
- —Typically documented as a project or product quality plan
- —Assigns ownership and timeline for required quality deliverables
- —Complements, but is distinct from, quality objectives
ISO 9001:2015 Clause 5.3 and Clause 6 (Planning); ICH Q10
Frequently asked questions
What is Quality Planning?
The systematic process of defining the quality objectives, resources, procedures, and verification points needed for a specific product, project, or process before work begins — commonly documented in a quality plan that identifies which SOPs, specifications, and acceptance criteria apply and where the quality unit must be involved.
Which regulations cover Quality Planning?
ISO 9001:2015 Clause 5.3 and Clause 6 (Planning); ICH Q10