Compliance tracking method

• US 6,839,604 B2
• Filed: 02/21/2001
• Issued: 01/04/2005
• Est. Priority Date: 02/26/2000
• Status: Expired due to Term

• Current Assignee: GlaxoSmithKline LLC (GlaxoSmithKline PLC)
• Original Assignee: Smithkline Beecham Corporation (Smithkline Beecham PLC)
• Inventors: Bonney, Stanley George, Godfrey, James William
• Primary Examiner(s): Picard, Leo
• Assistant Examiner(s): FRANK, ELLIOT L
• Application Number:
  US10/204,838
• Publication Number:
  US 20030023337A1
• Time in Patent Office: 1,413 Days
• Field of Search: 700/115, 700/116, 700/221, 700/225
• US Class Current: 700/116
• CPC Class Codes: A61P 11/08 Bronchodilators
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: G05B 19/4183 characterised by data acquisition, e.g. workpiece identification
• CPC Class Codes: G05B 2219/31283 Communication memory, storage, ram, eprom on workpiece or pallet
• CPC Class Codes: G05B 2219/31304 Identification of workpiece and data for control, inspection, safety, calibration
• CPC Class Codes: G05B 2219/32049 Store program data, manufacturing history on workpiece, shifts to next

Abstract

There is provided a method for automatically tracking compliance in a manufacturing process involving successive manufacturing operations comprising selecting an object; associating an identifier with said object, said identifier comprising a memory; performing a first manufacturing operation relating to the object; following the successful completion of said first manufacturing operation, writing an associated compliance data item to the memory; performing one or more further manufacturing operations relating to the object; and following the successful completion of each said further manufacturing operation or any package thereof, writing an associated compliance data item to the memory.

Claims

1. A method for automatically tracking compliance in a manufacturing process involving successive manufacturing operations comprising

selecting an object;

associating an identifier with said object, said identifier comprising a memory, wherein the identifier is a radiofrequency identifier comprising an antenna for transmitting or receiving radiofrequency energy; and

an integrated circuit chip, connecting with said antenna, said chip comprising the memory;

performing a first manufacturing operation relating to the object;

following the successful completion of said first manufacturing operation, writing an associated compliance data item to the memory;

performing one or more further manufacturing operations relating to the object; and

following the successful completion of said one or more further manufacturing operations, writing an associated compliance data item to the memory,

wherein said object retains said identifier through distribution to consumers.

2. A method according to claim 1, additionally comprising reading the memory prior to performing the first or any of the one or more manufacturing operations relating to the object.

3. A method according to claim 2, wherein said memory comprises a unique signature data item and said reading step comprises reading said unique signature data item.

4. A method according to claim 3, wherein said unique signature data item is read only prior to performing the first manufacturing operation.

5. A method according to claim 2, wherein said reading step comprises reading at least one compliance data item.

6. A method according to claim 5, additionally comprising checking said at least one compliance data item against a defined compliance criterion.

7. A method according to claim 6, wherein at least one compliance data item is associated with the last performed manufacturing operation or a package thereof.

8. A method according to claim 6, wherein non-compliance with any check results in the abandonment of the manufacturing process for the object.

9. A method according to claim 2, wherein reading of the memory is by wireless data transfer therefrom.

10. A method according to claim 1, additionally comprising a final reading step involving reading all compliance data items in the memory subsequent to the completion of all manufacturing operations.

11. A method according to claim 10, additionally comprising checking said all compliance data items against defined full compliance criteria.

12. A method according to claim 11, wherein compliance with said check results in writing of a full compliance data item to the memory.

13. A method according to claim 1, wherein the first manufacturing operation is carried out at a first manufacturing site and at least one of the one or more further manufacturing operations is carried out at a second or further manufacturing site.

14. A method according to claim 13, wherein the fist manufacturing site and said one or more further manufacturing sites are linked via a network computer system to enable transfer of data therebetween.

15. A method according to claim 1, wherein writing to the memory is by wireless data transfer thereto.

16. A method according to claim 15, wherein said wireless data transfer is by data transfer means selected from the group consisting of capacitative data transfer means, transformative coupling data transfer means, electrical data transfer means and magnetic data transfer means.

17. A method according to claim 15, wherein said wireless data transfer is by optical data transfer means.

18. A method according to claim 15, wherein said wireless data transfer is by radiofrequency data transfer means.

19. A method according to claim 1, wherein the antenna is capable of transmitting or receiving radiofrequency energy having a frequency of from 100 KHz to 2.5 GHz.

20. A method according to claim 19, wherein the antenna is adapted to transmit or receive radiofrequency energy having a frequency selected from the group consisting of 125 KHz, 13.56 MHz and 2.4 GHz.

21. A method according to claim 1, wherein the identifier connects to the object.

22. A method according to claim 1, wherein the manufacturing process is an assembly process.

23. A method according to claim 22, wherein the manufacturing process is a process for assembling a medical device.

24. A method according to claim 23, wherein the medical device is an inhalation device.

25. A method according to claim 1, wherein the object is a container and the manufacturing process is a container filling process.

26. A method according to claim 25, wherein the container is an aerosol container and the filling process involves filling the aerosol container with a suspension of a medicament in a propellant.

27. A method according to claim 26, wherein, said propellant comprises liquefied HFA134a, HFA-227 or carbon dioxide.

28. A method according to claim 27, wherein said aerosol container comprises a solution of a medicament in a solvent.

29. A method according to claim 25, wherein the container is a dry-powder container and the filling process involves filling the dry-powder container with medicament in dry-powder form.

30. A method according to claim 29, wherein said dry-powder container comprises a blister pack.

31. A method according to claim 25, said filling process involves filling said container with a medicament and wherein the medicament is selected from the group consisting of albuterol, salmeterol, fluticasone propionate, beclomethasone dipropionate, salts or solvates thereof and any mixtures thereof.

32. A method according to claim 1, wherein the radiofrequency identifier is on a carrier suitable for mounting to the object or a support therefor.

33. A method according to claim 32, wherein the carrier is a flexible label.

34. A method according to claim 32, wherein the carrier is a rigid disc.

35. A method according to claim 32, wherein the carrier is a rectangular block.

36. A method according to claim 32, wherein the carrier is mouldable to the object.

37. A method according to claim 32, wherein the carrier encases the identifier.

38. A method according to claim 37, wherein the carrier forms a hermetic seal for the identifier.

39. A method according to claim 32, wherein the carrier comprises an insulating material.

40. A method according to claim 39, wherein the insulating material comprises a glass material, paper material or organic polymeric material.

41. A method according to claim 39, wherein the carrier comprises a ferrite material.

42. A method according to claim 1, wherein the memory is integrated memory having plural memory areas thereon.

43. A method according to claim 42, wherein any memory area contains data in encrypted form.

44. A method according to claim 1, additionally comprising transferring each compliance data item read from the memory to an electronic data management system comprising

a data memory for storage of data;

a microprocessor for performing operations on said data; and

a signal output for outputting a signal relating to the data or the outcome of an operation on the data.

45. A method according to claim 44, wherein the electronic data management system forms part of a robotics system.

46. A method according to claim 44, additionally comprising communicating with a gateway to a network computer system to enable transfer of data between the network computer system and the electronic data management system or any individual electronic data collectors thereof.

47. A method according to claim 46, enabling two-way transfer of data between the network computer system and the electronic data management system.

48. A method according to claim 46, wherein the data are communicable between the network computer system and the electronic data management system in encrypted form.

49. A method according to claim 46, wherein the network computer system comprises a public access network computer system.

50. A method according to claim 46, wherein the network computer system comprises a private access network computer system and the gateway is a secure gateway.

51. A method according to claim 46, comprising communicating with a user-specific network address in the network computer system.

52. A method according to claim 51, wherein the user-specific network address is selected from the group consisting of a web-site address an e-mail address and a file transfer protocol address.

53. A method according to claim 1, additionally comprising transferring each compliance data item read from the memory to a distributed electronic data management system comprising plural electronic data collectors, each comprising

a data memory for storage of data;

a microprocessor for performing operations on said data; and

a signal output for outputting a signal relating to the data or the outcome of an operation on the data,

wherein said plural electronic data collectors are in networked relationship to form said distributed electronic data management system.

54. A computer program product comprising a computer readable recording medium having recorded thereon a computer program comprising code means for, when executed on a computer, instructing said computer to control the steps in a method for automatically tracking compliance in a manufacturing process involving successive manufacturing operations of

selecting an object;

associating an identifier with said object, said identifier comprising a memory, wherein the identifier is a radiofrequency identifier comprising an antenna for transmitting or receiving radiofrequency energy; and

an integrated circuit chip connected with said antenna, said chip comprising the memory;

performing a first manufacturing operation relating to the object;

following the successful completion of said first manufacturing operation, automatically writing an associated compliance data item to the memory;

performing one or more further manufacturing operations relating to the object; and

following the successful completion of said one or more further manufacturing operations, writing an associated compliance data item to the memory.

wherein said object retains said identifier through distribution to consumers.