REPORTREFERENCE OUTLINE

Site Selection & Feasibility Assessment

Structured comparison and decision-record template for choosing a manufacturing site: candidate matrix, regulatory jurisdiction and inspection-regime analysis, utilities and infrastructure feasibility, workforce and supply-chain factors, EHS/permitting, and a defensible recommendation.

What a template is not

A template is a document baseline to adapt inside your own quality system. SPEQ does not approve, validate, or take responsibility for what you issue from it, and using one is not evidence of compliance.

CHECKING ACCESS

Checking your Professional access…

REGULATIONS MAPPED
ISPE Good Practice Guide: Project ManagementICH Q9(R1)
DOCUMENT TYPE
Report
LAST UPDATED
August 2026
PURPOSE

The record of why one site was chosen over the others, written while the alternatives are still live rather than reconstructed years later when an inspector asks. The jurisdiction decision is the one that outlives every other criterion — it determines which authority inspects the facility for its operating life. Weighting the criteria is the organisation’s judgement; the template only insists that the weighting is agreed before scoring starts.

What's Inside

Evaluation criteria and weightings, fixed before any candidate is scored so the result is not reverse-engineered
Weighted candidate comparison matrix, with the evidence behind each score recorded next to it
Regulatory jurisdiction analysis per candidate — which authority inspects, under which regime, at what cadence
Utilities and infrastructure feasibility, including the capacity headroom the site will need at year five
Workforce availability and supply-chain feasibility, tested against the skills the process actually requires
EHS, permitting and zoning review, with the permits whose lead time gates the schedule flagged
Recommendation and sponsor decision record, capturing the criteria that were traded away and why

How to Use It

1Agree the criteria and their weightings with the sponsor before scoring anything; weightings set after scoring will read as justification
2Score each candidate against evidence you can cite — a site visit, a utility study, a permit register — not impressions
3Analyse the regulatory jurisdiction and inspection regime for every candidate, including the markets you intend to supply from it
4Verify utilities, workforce and permitting with the local authority or provider rather than with the developer selling the site
5Record the criteria you knowingly traded away; a matrix showing only strengths is the version nobody believes later
6Capture sponsor sign-off as the decision record, and reopen it formally if the product mix or target markets change
DOCUMENT CONTENTS

The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.

Document Control
Document InformationApproval SignaturesRevision HistoryDistribution List
1Purpose, Scope, and Evaluation Method
2Candidate-Site Comparison Matrix
3Regulatory Jurisdiction and Inspection-Regime Analysis
4Utilities and Infrastructure Feasibility
5Workforce and Supply-Chain Feasibility
6EHS, Permitting, and Zoning
7Recommendation and Decision Record
REGULATORY CONTEXT

No authority licenses a site selection. The ISPE Good Practice Guide: Project Management frames it as a project-governance decision with a defined stage gate, and ICH Q9(R1) supplies the risk-management thinking applied to jurisdiction, utility and supply-chain risk. What no guidance decides is your weighting, your risk appetite, or which criterion is allowed to veto a candidate. The comparison structure here is SPEQ synthesis; the obligation it serves is that the decision remain explicable long after the alternatives are forgotten.

MAPPED STANDARDS
ISPE Good Practice Guide: Project ManagementICH Q9(R1)
Browse the standards catalog →