Standards Development

Scope

This document specifies the general terminology, requirements, procedures and documentation for temperature validation that shall be used for temperature-controlled storages and road vehicles. This document does not intended to evaluate the safety and technology of storage and transportation equipment or facilities

Purpose

Cold chain management is a crucial element in the temperature sensitive product storage and distribution process in temperature-controlled environments. It has been growing due to the expansion and complexity to maintain the right temperature throughout the supply chains. It is important to keep the quality of components as planned, while appropriately controlling all procedures including not only manufacturing, but also storage and transportation processes. In order to verify the integrity of cold chain, it should be possible to perform risk-based analyses and inspections at the highest scientific level possible, and to be documented within a quality system.

Validation of devices and equipment related to storage and transportation during distribution is an important activity of integrated supply chain management for handling, storage and distribution of temperature-sensitive products. It aims to help ensure the quality and integrity of temperature-sensitive products in cold chain management.

If the temperature is not properly controlled or guaranteed, the quality of temperature-sensitive products will be affected, so the safety, stability and efficiency of users cannot be guaranteed.

This standard helps all parties involved in handling temperature-sensitive products, including governments, regulators and cold-chain professionals, ensure the integrity of temperature-sensitive products through a temperature validation process during storage and distribution of temperaturesensitive products. This standard should be beneficial not only for manufacturers of finished goods and distributors of temperature-sensitive products, but also for companies involved in the production, logistics and distribution of temperature-sensitive products, such as brokers, suppliers, logistics companies, business partners, transport companies and carriers.

This standard applies to the verification of storage and road vehicles for quality control during distribution of temperature-sensitive products. It also provides people, equipment and facilities, materials, procedures and methods for quality control.

Within ISO TC315, WG3 (Services between businesses - Storage and Transport) is currently developing ISO/AWI 31512 (Cold chain logistics services in B to B sector - Requirements for low temperature storage services and low temperature transport services Low temperature storage services and low temperature transport services for food.)

The Scope of NP specifies the temperature validation related terms, requirements for the procedures and documents of storage and road vehicle while WD31512 is focusing on B2B service and business. NP is focusing on equipment and technical qualification and validation. WD31512 is more focusing on management and business service contract.

If there is any duplicated or overlaps, it shall be avoided in the drafting process.

An initial draft is attached in separate document. The proposed contents are:

Foreword

Introduction

1 Scope

2 Normative references

3 Terms and definitions

4 General requirement 4.1 Storage 4.2 Road vehicles

5 Validation procedure

5.1 General

5.2 Validation Plan

5.3 User Requirement Specification

5.4 Design Qualification

5.5 Installation Qualification

5.6 Operation Qualification

5.7 Performance Qualification

5.8 Re-Qualification

6 Validation Report Annex A(Informative) Examples of validation process (to be added)

Bibliography