WO2014062914A1

WO2014062914A1 - Method and system for verifying a product packaging label

Info

Publication number: WO2014062914A1
Application number: PCT/US2013/065426
Authority: WO
Inventors: Dennis MCLAUGHLIN
Original assignee: Nutec Systems, Inc.
Priority date: 2012-10-18
Filing date: 2013-10-17
Publication date: 2014-04-24
Also published as: WO2014062914A8

Abstract

A method, device, and system are disclosed for scanning a product packaging label. The method of using the device and system includes storing, in the batch record memory, batch record data that contains information related to a batch of products being packaged on a product packaging line. The scanner is used, in accordance with a sample plan, to scan a package code on a product packaging label affixed to a product package on the product packaging line. The package code on the product package is decoded to obtain package data that contains information related to a product in the product package and is stored in the package data memory. The package data and the batch record data are compared. If the package data and said batch record data match, indicate that package data has been verified. Otherwise, the package data is not verified.

Description

METHOD AND SYSTEM FOR VERIFYING A PRODUCT PACKAGING LABEL

REFERENCE TO RELATED APPLICATIONS

[0001] This application is a non-provisional application claiming priority to U.S.

Provisional Patent Application Serial Nos. 61/715,601 filed October 18, 2012 and 61/716,743 filed October 22, 2012, both of which are hereby incorporated by reference as if fully disclosed herein.

FIELD OF THE DISCLOSURE

[0002] The present disclosure relates to automated methods for verifying product packaging labels. More specifically, the present disclosure relates to systems and methods for verifying the validity and accuracy of product packaging labels in regulated industries where labeling accuracy is critical.

BACKGROUND OF THE INVENTION

[0003] In the past, the data applied to Products (Lot Code, Expiration Date, etc.) was overwhelmingly of the human readable (e.g., alpha-numeric) format, and could be verified visually. Due to the increase in data required to meet the new regulations (potentially up to 60 alpha-numeric characters), regulating agencies world-wide have begun to specifically recommend and/or standardize the use of two dimensional (2D) barcodes, e.g., error correct code (ECC) 200 data matrix codes such as those used in the Global Specifications (GS1) standard.

[0004] The data encoded in the GS1 code can identify the product by global trade identification number (GTIN), lot number, expiration date, and unique identification number (UID). This information can be used to identify counterfeit product, diverted product, and/or in product recalls. [0005] The ECC200 data matrix code, by design, is not human readable, so manual (visual) verification of the code data is not possible. The verification activities are currently performed by the manufacturer quality assurance (QA) group at the manufacturing/packaging line. The QA representative removes product samples from the line, and scans the 2D Codes using a hand held scanner. The scanned code data is then visually verified, ensuring that the code is proper (relative to batch record data). This procedure is performed periodically during a Product run, and is referred to as line sampling. The risk with this process, as it exists, is that the validity of the data scanned by QA personnel is still verified by a visual comparison of the scanned data and the Batch Record data. With a potential of more than 60 characters encoded in the 2D code, the opportunity for "human error" mistakes is greatly increased.

[0006] In Bansal et al., "Anti-Counterfeit Technologies: A Pharmaceutical Industry Perspective," illustrates many of the important issues that are raised when product labels are not properly verified. There have been a number of attempts to solve these problems by automating portions of the in-line packaging labeling process. For example, U.S. Application Publication No. 2007/0145142 to Lubow et al. discloses a method and system for applying bar code information to products during manufacturing production with information associated with the production run. However, Lubow only checks for inconsistencies that between data elements on the same label. U.S. Patent No. 6,819,975 to Watanabe discloses a method of using bar codes to control production of semiconductor devices. The method of Watanabe prints a barcode on a semiconductor that is used by the production line to encode process parameters that are to be used to manufacture a semiconductor device, thereby eliminating human errors associated with data entry of the process parameters. Other examples include U.S. Patent No. 6,027,022 to Hong and U.S. patent No. 8,175,732 to Dam et al. both of which describe methods and systems associated with improving quality in a production line.

SUMMARY OF THE INVENTION

[0007] A method, device, and system are disclosed for scanning a product packaging label. The system and device includes a processor, a scanner, a memory that includes a batch record data memory and a package data memory, and a computer readable storage medium. The system and device are specifically adapted to perform the disclosed method.

[0008] The method includes storing, in the batch record memory, batch record data that contains information related to a batch of products being packaged on a product packaging line. The scanner is used, in accordance with a sample plan, to scan a package code on a product packaging label affixed to a product package on the product packaging line. The package code on the product package is decoded to obtain package data that contains information related to a product in the product package and is stored in the package data memory. The package data and the batch record data are compared. If the package data and said batch record data match, indicate that package data has been verified. Otherwise, the package data is not verified.

BRIEF DESCRIPTION OF THE DRAWINGS

[0009] Embodiments will be described with reference to the following drawing figures, in which like numerals represent like items throughout the figures, and in which:

[0010] FIG. 1 is a flow chart showing a method for verifying a product packaging label;

[0011] FIG. 2 is a flow chart showing a method for re-verifying a product packaging label that generated an error

[0012] FIG. 3 is a flow chart showing a method for verifying a product packaging label on a returned product package; [0013] FIG. 4 is a flow chart showing a method for verifying a product packaging label product package in the field;

[0014] FIG. 5 is a block diagram of computer hardware capable of implementing the methods described herein; and

[0015] FIG. 6 is an example of a display screen for displaying product packaging codes.

DETAILED DESCRIPTION

[0016] The disclosed systems and methods are intended to minimize the effects of human error in the packaging industry. Although specifically tailored to regulated industries where package labeling accuracy is critical, the systems and methods described in this document may also be useful in any process where accuracy of machine readable codes is of high importance. The suite of applications implementing the methods focus on separate yet connected areas, for example, batch verification and track and trace/EPedigree programs. Batch verification will ensure that imported batch information received matches what is actually printed on the production line. This program is to be used to assist companies with their standard operating procedures (SOP) and to give a high level of confidence to completed batches.

[0017] The disclosed system is part of a software suite for use in regulated industries (e.g., pharmaceuticals, medical device, foods, and the like) which must provide users and customers with a high level of confidence that regulatory requirements relating to product labeling and identification are met. Use in non-regulated industries may be beneficial as well. In one implementation, the system is Windows-based. In alternate implementations, the system may be based on a mobile platform, e.g., Android, iOS, or other mobile platform.

[0018] The disclosed method and software application may be used to specifically address potential "human error" occurrences in the execution of a sample plan on a production line. A sample plan defines the length of time between sample verification and how many samples are removed from the line for verification. Human errors may occur during the setup of the sample plan and during the application of global marking standards (e.g., GSl 2D Codes) on regulated products within the Product Manufacturing and Packaging environs. Federal agencies (e.g., the Food and Drug Administration (FDA), for example) have recommended the use of codes formatted to the GSl standard. These codes are not human readable. However, product packages must still be sampled out of the production line and checked.

[0019] The disclosed system is capable of performing code verification on all currently used code formats. Specifically, the FDA regulations covering "E Pedigree/Track and Trace" activities (currently set to take effect in 2015) may result in increased amounts of data being developed and attached to product labels at the manufacturing and packaging floor level. The integrity of this data is critical since improper data can result in a product recall and/or other liability issues. If used effectively the disclosed system and method can assist in the elimination of quarantine items on the batch and recalls due to incorrect printed batch information.

[0020] Software attributes of the disclosed system include password protection to ensure that only the appropriate level of personnel have access. The software suite can also include an electronic signature for records management purposes.

[0021] In addition to the areas described above, the disclosed system can also be utilized for the following internal and/or external tasks: aid in the area of reworks in current batch process; screen returns to manufacturer for counterfeit products; and external product verification for diverted products. Counterfeit products are products that are not genuine but are passed off as genuine products. Diverted products are genuine products that are diverted out of a controlled and specified chain of custody or distribution channel. Both counterfeit and diverted products present serious safety and quality concerns to the industry, government regulators, and the public.

[0022] Referring to FIG. 1, flow chart is provided that shows a preferred embodiment of a method 100 for verifying product packaging label. The method 100 begins when batch record data is received 102. A batch record is a set of data that defines a batch of products being packaged. In an example in the pharmaceutical industry, the batch record may include a global trade identification number (GTIN), a lot number, and an expiration date. The batch record may also include information defining a unique identification number for each product package, e.g. a number of digits or a particular format of characters the UIN must have. In the pharmaceutical example, this information may be used to identify counterfeit products and/or diverted products or in product recalls.

[0023] The batch record data may be presented in any form without departing from the spirit of the disclosed embodiments. In a preferred embodiment, the batch record data is presented in the form of a machine-readable code, as described above. The batch record code may be scanned and, optionally, displayed in a batch record code field 104. The data is checked to ensure it is a correct format 106. The data check may include a code length check, a code format check, or any other check useful for determining whether the code is valid. Importantly, the code check at step 106 does not include any check to ensure that the encoded information is correct. The batch record is assumed to accurately reflect the information that is intended to be placed on the label, and provides a reference to conduct spot checks of the labeling printing and packing process. The purpose is not to confirm the accuracy of the batch record itself. If there is a code error, e.g., if the code length or format is incorrect (such as too many or too few characters), a system error may be triggered and the operator is alerted 108. After the batch record code is reviewed and corrected, the corrected batch record code is received 102, the corrected code is scanned 104, and the code is validated 106.

[0024] In the preferred embodiment, a screen is used to display the scanned data. An example screen is provided in FIG. 6. Referring to FIG. 6, the valid code data string may be displayed on the application display in the "BATCH RECORD 2D SCAN" field 602. The batch record data string may be separated into its constituent parts. In the example of a pharmaceutical label, the batch record data includes a GTIN which may be displayed in the "BATCH RECORD GTIN" field 604, a UIN or serial number which may be displayed in "BATCH RECORD SERIAL NUMBER" field 606, an expiration date which may be displayed in "BATCH RECORD EXP DATE" field 608, and a lot number which may be displayed in "BATCH RECORD LOT CODE" field 610.

[0025] Once a valid code is read, it is accepted and held in a buffer or memory for comparison to in-process codes, discussed in more detail above. All subsequent in-process code reads will be compared to this data string for match. If no error is found, the method 100 may then be used to conduct spot checks of in-process product packaging. An in-process code (i.e., a code currently being printed on a product component in the packaging line) may be scanned, and, optionally, displayed in an in-process data field 110. The in-process scanned code data may be compared to the previously scanned batch record code data 112. The in-process scanned code data must exactly match the data provided on the batch record. In the pharmaceutical industry example described above, the GTIN in the batch record data must exactly match the GTIN in the in-process data. Similarly the expiration data and lot number must exactly match. The UIN need not match exactly since each number is unique, but the format of the UIN must also match exactly. [0026] In the preferred embodiment, a screen is used to display the scanned data. An example screen is provided in FIG. 6. Referring to FIG. 6, the valid code data string may be displayed on the application display in the "IN PROCESS GS1 CODE" field 612. The in process data string may be separated into its constituent parts. In the example of a pharmaceutical label, the batch record data includes a GTIN which may be displayed in the "IN PROCESS GTIN" field 614, a UIN or serial number which may be displayed in "IN PROCESS SERIAL NUMBER" field 616, an expiration date which may be displayed in "IN PROCESS EXP DATE" field 618, and a lot number which may be displayed in "IN PROCESS LOT CODE" field 620.

[0027] If the in-process code data and the batch record code data do not exactly match, a system error is triggered and the operator is alerted 114. In the case of an error, the process line is stopped and all packaging that has gone through the packaging process line since the previous code check is quarantined for rework. Referring now to FIG. 2, a method 200 for reworking packaging labels is shown. The error is first characterized 202. In the example of the pharmaceutical label, the error is characterized by determining which of the constituent codes creates the error. In the example of a pharmaceutical packaging label, the expiration date may have been changed, for any number of reasons, from what is required by the batch record. In this example, the data shown in "IN PROCESS EXP DATE" field 618 will be displayed in red, allowing an operator to see that the error was caused by an invalid expiration date. Once the error is confirmed, corrected labels may be printed that include corrected in-process data codes 204. The in-process data code is rescanned and checked for additional errors 206. If additional errors exist, method 200 is repeated. If there are no more errors, an indication that the reworked packaging has been verified is displayed and the package is replaced in the line and/or batch 208. [0028] Referring again to FIG. 1, if the in-process code data matches the batch record code data, the method 100 determines if there are any more packages in the batch 116. If the codes do match, method 100 returns to scan another package code 110 and steps 110-112 are repeated until there are no more packages in the batch. Optionally, the method 100 may generate a verification record 118. The verification record may include a batch number, a count of the total scanned items, number of error codes, a date and time stamp, and the like. Method 100 may also provide a mechanism for an operator to electronically sign the verification record 120.

[0029] Referring now to FIG. 3, a method 300 for processing returned items is shown. Return item data is received and associated with the appropriate batch record that was used when the items were initially packaged 302. The returned item data code is scanned 304. Similar to method 100 of FIG. 1, the returned item data code is compared to batch record code data 306. If the codes do not match, a system error may be triggered and the operator is alerted 308. Because the error occurs with respect to a returned item, that initial left the packaging plant with a correct label, the returned item may be counterfeit or otherwise tampered with. The item may, therefore, be quarantined. If the codes do match, the returned item is processed 310. If returned item is a warranty return, the processing may include refurbishing and replacing the item into inventory. In the case of a product recall, the processing may include destruction or repair of the item to correct for whatever defect caused the recall. One of skill in the art will recognize that the disclosed embodiments are not limited in this regard.

[0030] Referring now to FIG. 4, a method 400 is provided for scanning items in the field to check for counterfeit or diverted items. An item is scanned in the field 402. Advantageously, the scanner used to scan the field item may be any portable consumer device capable of reading codes. In one scenario, a tablet personal computer may be used to scan the item with a camera. In another scenario a smart phone may be used. The disclosed embodiments are not limited in this regard. The data may be transmitted to a server 404. The server may be any computing device connected a network accessible by the scanner. In a preferred embodiment, the server is accessible through the Internet. The server maintains a database of valid product codes which may have been used as batch records during the packaging process for the scanned item. Therefore, the server can compare data transmitted from the scanner to the data for that item to ensure the code on the item is valid 406. If the code is not valid, the display on the tablet and/or smart phone will show the item code as invalid and flag the item in the server 408. If the code is valid, the display on the tablet and/or smart phone may show the item code as valid and update the item status in the server 410.

[0031] FIG. 5 depicts a block diagram of hardware that may be used to contain or implement program instructions to perform the methods described above. A bus 500 serves as an information highway interconnecting the other illustrated components of the hardware. CPU 505 is the central processing unit of the system, performing calculations and logic operations required to execute a program. CPU 505, alone or in conjunction with one or more of the other elements disclosed in FIG. 4, is an example of a production device, computing device or processor as such terms are used within this disclosure. Read only memory (ROM) 510 and random access memory (RAM) 515 constitute examples of non-transitory computer-readable storage media.

[0032] A controller 520 interfaces with one or more optional non-transitory computer- readable storage media 525 to the system bus 500. These storage media 525 may include, for example, an external or internal DVD drive, a CD ROM drive, a hard drive, flash memory, a USB drive or the like. As indicated previously, these various drives and controllers are optional devices. [0033] Program instructions, software or interactive modules for providing the interface and performing any querying or analysis associated with one or more data sets may be stored in the ROM 510 and/or the RAM 515. Optionally, the program instructions may be stored on a tangible non-transitory computer-readable medium such as a compact disk, a digital disk, flash memory, a memory card, a USB drive, an optical disc storage medium, such as a Blu-ray™ disc, and/or other recording medium.

[0034] An optional display interface 540 may permit information from the bus 400 to be displayed on the display 545 in audio, visual, graphic or alphanumeric format. Communication with external devices, such as a printing device, may occur using various communication ports 550. A communication port 550 may be attached to a communications network, such as the Internet or an intranet.

[0035] The hardware may also include an interface 555 which allows for receipt of data from input devices such as a keyboard 560 or other input device such as a mouse, a joystick, a touch screen, a remote control, a pointing device, a video input device and/or an audio input device. Additionally, the hardware may include a scanner 565.

[0036] Although the invention has been described and illustrated in the foregoing illustrative embodiments, it is understood that the present disclosure has been made only by way of example, and that numerous changes in the details of implementation of the invention can be made without departing from the spirit and scope of the invention, which is limited only by the claims which follow. Features of the disclosed embodiments can be combined and rearranged in various ways.

Claims

CLAIMS We claim:

1. A method for verifying the accuracy of a product packaging label, the method

comprising:

receiving batch record data, wherein said batch record data contains information related to a batch of products being packaged on a product packaging line;

scanning a package code, in accordance with a sample plan, on a product packaging label affixed to a product package on said product packaging line;

decoding said package code on said product package to obtain package data, wherein said package data contains information related to a product in said product package;

comparing said package data with said batch record data; and

if said package data and said batch record data match, generating an indication that said package data has been verified.

2. The method according to claim 1, further comprising:

scanning a batch record code from a batch record sheet; and

decoding said batch record code to obtain said batch record data.

3. The method according to claim 2, further comprising:

comparing said batch record data obtained from said batch record code to a batch record format; if said batch record data obtained from said batch record code matches said batch record format, indicating that the batch record code is verified; and

if said batch record data obtained from said batch record code does not match said batch record format, alerting an operator.

4. The method according to claim 3, wherein alerting an operator comprises:

parsing said batch record data obtained from said batch record code to produce a plurality of data elements; and

displaying the plurality of data elements with an indicator that indicates whether a particular one of said plurality of data elements matches said batch record format.

5. The method according to claim 1, further comprising:

after all product packages in a batch are verified, generating a verification record for the batch; and

receiving an electronic signature.

6. The method according to claim 1, further comprising:

if said package data and said batch record data does not match, alerting an operator with an error message.

7. The method according to claim 6, wherein alerting an operator comprises:

parsing said package data to produce a plurality of data elements; and displaying the plurality of data elements with an indicator that indicates whether a particular one of said plurality of data elements matches said batch record data.

8. The method according to claim 7, further comprising:

scanning a corrected product packing label on said product package;

decoding said package code on said product package to obtain corrected package data; and

if said corrected package data matches said batch record data, displaying an indication that said corrected package data has been verified.

9 The method according to claim 8, further comprising:

receiving return batch code data for a returned package, wherein said return batch code data is said batch record data used when packaging said returned package;

scanning a return package code on a return packaging label on said returned package; and decoding said return package code to obtain said return package data.

10. The method according to claim 9, further comprising:

comparing said return package data to said return batch code data;

if said return package data matches said return batch code data, display an indication that the returned package is acceptable; and

if said return package data does not match said return batch code data, display an indication that the returned package is not acceptable.

11. A device for scanning a product packaging label, the device comprising:

a processor;

a scanner;

a memory that includes a batch record data memory and a package data memory; and a computer readable storage medium for storing program instructions that, when executed, cause the processor to:

store, in said batch record memory, batch record data, wherein said batch record data contains information related to a batch of products being packaged on a product packaging line;

scan, using said scanner and in accordance with a sample plan, a package code on a product packaging label affixed to a product package on said product packaging line; decode said package code on said product package to obtain package data, wherein said package data contains information related to a product in said product package and is stored in said package data memory;

compare said package data with said batch record data; and

if said package data and said batch record data match, indicate that package data has been verified.

12. The device according to claim 11, wherein the program instructions, when executed, further cause the processor to:

scan, using the scanner a batch record code from a batch record sheet; and

decode said batch record code to obtain said batch record data.

13. The method according to claim 12, further comprising a display, wherein the program instructions, when executed, further cause the processor to:

compare said batch record data obtained from said batch record code to a batch record format;

if said batch record data obtained from said batch record code matches said batch record format, indicate, on the display, that the batch record code is verified; and

if said batch record data obtained from said batch record code does not match said batch record format, indicate, on the display, that the batch record code is not verified.

14. The method according to claim 13, wherein the program instructions, when executed, further cause the processor to:

parse said batch record data obtained from said batch record code to produce a plurality of data elements; and

display, using said display, the plurality of data elements with an indicator that indicates whether a particular one of said plurality of data elements matches said batch record format.

15. The method according to claim 11, wherein the program instructions, when executed, further cause the processor to:

after all product packages in a batch are verified, generate a verification record for the batch; and

receive an electronic signature.

16. The method according to claim 11, wherein the program instructions, when executed, further cause the processor to:

if said package data and said batch record data does not match, alert an operator with an error message.

17. The method according to claim 16, further comprising a display, wherein the program instructions, when executed, further cause the processor to:

parse said package data to produce a plurality of data elements; and

display, using said display, the plurality of data elements with an indicator that indicates whether a particular one of said plurality of data elements matches said batch record data.

18. The method according to claim 17, wherein the program instructions, when executed, further cause the processor to:

scan, using the scanner, a corrected product packing label on said product package;

decode said package bar code on said product package to obtain corrected package data; and

if said corrected package data matches said batch record data, display, using said display an indication that said corrected package data has been verified.

19 The method according to claim 18, wherein the program instructions, when executed, further cause the processor to:

receive return batch code data for a returned package, wherein said return batch code data is said batch record data used when packaging said returned package; scan a return package code on a return packaging label on said returned package; and decode said return package code to obtain said return package data.

20. The method according to claim 19, wherein the program instructions, when executed, further cause the processor to:

compare said return package data to said return batch code data;

if said return package data matches said return batch code data, display, using said display, an indication that the returned package is acceptable; and

if said return package data does not match said return batch code data, display, using said display, an indication that the returned package is not acceptable.