Agree on who decides before the study starts.
A protocol discussion should settle more than a deployment date. Use this guide to identify the decisions, records and people your proposed study needs. It is a preparation checklist, not a validated protocol or an approval to begin work. Your quality team determines the applicable requirements and approves the study criteria.
Request a mapping quoteDefine what the approval covers
- Purpose and decision
- State whether the request concerns a new area, a change, an investigation or another purpose. Name the decision that depends on the findings, and distinguish that decision from simply receiving a report by a certain date.
- Boundaries and conditions
- List the areas, loading states and operating conditions proposed for assessment. Mark exclusions and unknowns. Ask which layout version, equipment settings and site information reviewers need before accepting the scope, rather than leaving those choices to deployment day.
- Criteria and their owner
- Provide the proposed temperature limits and the product or internal requirements behind them. Identify who approves acceptance criteria, recording settings and study duration. Separate confirmed requirements from preferences or assumptions that still need a documented decision.
Assign execution and exception decisions
- Author, reviewer and site contact
- Identify who prepares the protocol, who reviews it and who authorizes execution. Name an operational contact who can arrange access and record relevant site activity. Confirm how the team will know it holds the approved version before starting.
- Changes and deviations
- Agree on how to record an unavailable location, a moved sensor, an unplanned operating event or missing data. Identify who assesses the effect on the study, who authorizes a change, and how the original records remain available for review.
- Interruption and escalation
- Decide whom staff contact when the planned conditions cannot be maintained. Define who can pause work, protect stock and authorize resumption. Any deliberate challenge needs separately agreed authorization and stop conditions; a mapping request does not grant that permission.
Make the handover reviewable
- Records and deliverables
- List the placement records, sensor identification, calibration evidence, data files and operating notes expected in the handover. Confirm file formats, document language and review rounds in the written scope. Do not assume a report automatically includes every supporting file.
- Results and unresolved questions
- Ask how the report will distinguish the planned study from the conditions actually recorded. Agree how deviations, data gaps and limitations will be presented, and identify the quality reviewer responsible for deciding whether the evidence answers the original question.
- Acceptance and follow-up
- Assign responsibility for report acceptance and any corrective action. Clarify whether additional analysis or a repeat study requires a separate scope. A report handover does not itself authorize product release, use of an area or closure of a quality issue.
Methodology and further reading
WHO separates protocol preparation, approval, execution and reporting for storage-area mapping.
- WHO: Temperature mapping of storage areas, Supplement 8 (2015)
- ATEK guide to USP <1079.4>
- ATEK guide to ISPE temperature mapping
These resources inform scoping; they do not determine which requirements apply to your facility. Your quality team confirms the applicable requirements and approves the protocol.
Continue planning your study
Start with the information you have.
Tell us what needs mapping, where the site is and when you need the work. Mark unknown details as unknown. ATEK confirms service availability, scope and scheduling during review.