IATA Chapter 17 Update on Changes. Donald Harrison, United Airlines Cargo

Transcription

1 IATA Chapter 17 Update on Changes Donald Harrison, United Airlines Cargo

2 Needs Identified Gap in the Cold Chain Airlines were identified as a broken link in the cold chain for transporting time and temperature sensitive health care products. Improve air freight logistics for highly hl regulated healthcare freight 60% of the total time a package travels by air is spent at the airport As much as 54% of temperature excursions of healthcare freight occurs while in possession of the airlines 81

3 IATA Time and Temperature Task Force Dominique Coultier Air France / KLM Shirley-Ann Feld Sanofi-Aventis Mary Foster Catalent t Pharma Solutions Donald Harrison United Airlines Franco Nanna CargoLux Kevin O Donnell Chair, TTTF ThermoSafe Brands Aynur Rasulova-Rzepa Co-chair, Emirates Cargo Hany Ahmed Ragab Egypt Air Mark Mohr Continental Air Cargo Nicolas Walzik Lufthansa Air Cargo Tony Wright Excelsius, UK Francis i Yuen Cathay Pacific 82

4 TTTF Directive The Guiding Principal Develop minimum standards for the air transport and handling of time and temperature-sensitive healthcare freight. - Gregg Pittlekow, Chair, Live Animals & Perishables Board, IATA 83

5 TTTF Realignment March 2010 IATA Time & Temperature Task Force (Airline Members Only) TTTF Advisory Body TTTF Care Team (Organization Representation) (Subject Matter Experts) 84

6 TTTF Advisory Body March Subject Matter Experts from industry NGO s Industry Associations Regulatory Bodies Standards Organizations 85

7 TTTF Care Team March Subject Matter Experts from industry Logistics Drug Manufacturing Active/Passive Packaging Systems Freight Forwarding Training 86

8 Major Changes 9 th Edition of IATA PCR, Chapter 17 Quality Management Systems requirements Shipper, forwarder, ground handlers/transportation t ti service provider, consignee, and air carrier processes and responsibilities Product storage/handling temperature ranges Critical control points Storage and warehousing requirements (including temperature mapping) Training expectations Introduction of a new Handling Label usage requirement (effective July 1, 2010) 87

9 Quality Managements Systems 9 th Edition of IATA PCR, Chapter 17 Must be developed and utilized by the airline to ensure alignment with requirements of the Healthcare Sector Quality or Service Level Agreements Approved written procedures w/ change control Individual roles and responsibilities Documented training program Quality metrics Audit program Corrective and preventative action (CAPA) program 88

10 Roles and Responsibilities Defined 9 th Edition of IATA PCR, Chapter 17 Includes defined roles and responsibilities for logistics providers Shipper Forwarder Ground transportation providers Airlines Consignees 89

11 Product Temperature Ranges 9 th Edition of IATA PCR, Chapter 17 Includes standardized product temperature ranges Refrigerated: +2 C to +8 C Controlled Room Temperature: +15 C to +25 C (with some allowances for brief exposures to +15 C to + 30 C ) Protect from Freezing: Products that have temperature stability above +2 C but cannot be frozen Deep Frozen: -10 C or colder 90

12 Critical Control Points 9 th Edition of IATA PCR, Chapter 17 Defines critical control points during the logistics chain Product/package preconditioning Product loading Ground transportationt ti Warehousing Tarmac/airport apron Aircraft cargo hold 91

13 Storage and Warehousing Requirements 9 th Edition of IATA PCR, Chapter 17 Provides storage and warehousing process guidance for airlines, forwarders and shippers First document to provide guidance to airlines for handling of time and temperature sensitive healthcare products Outlines steps for storage and handling through all phases of the airline process Booking Acceptance Warehousing Tarmac transport Loading 92

14 Training Programs 9 th Edition of IATA PCR, Chapter 17 Training programs should address policies, processes, procedures and written instructions related to operational activities, products/services, and the quality system Classroom or E-learning Practical on the job training (OJT) Written tests or demonstration of task Documented training records 93

15 Time and Temp Handling Label Label and Label Requirements High visibility to handlers 4 x 4 Must be used in conjunction with QMS between shipper and TSP Unique to healthcare but does not allude to contents Conveys external handling temperaturest Label typically added by shipper Optional temperature range designation area if included on AWB and Quality Agreement. Otherwise handling temperatures assumed to be +15 to +25C Area for carrier operations information Sunset date, July 1,

16 TTTF Next Steps TTTF/05 April Hosted by Continental Airlines in Houston, TX Nominations for TTTF Chairperson Nominations for Advisory Board members Nominations for Care Team members Develop IATA certified training program Seek regulatory recognition of Chapter 17 95