Appeared in Good Packaging Magazine
Janssen Pharmaceutica, Inc. is a manufacturer of pharmaceutical drugs with multiple manufacturing locations. In the last five years, the company has increased the number of products in its line from 8 to 30 resulting in an increase from 250 to 1600 packaging documents.
In the early phases of this expansion, it became clear that the company's existing manual specification management process would soon be overwhelmed. Accordingly, a search was initiated to identify a better way to manage the documentation. The old, manual process consisted of creating specifications on a word processor and routing them to the personnel involved for approval or dissemination for documentation purposes. It often took a week or two (or more) to disseminate the documents. Afterwards they were frequently misplaced. These difficulties were overcome by installing a quality assurance / packaging specifications database system called PC-SPECS from Keene Systems, Inc. This software system manages all aspects of specification information, including CAD drawings, graphics and supporting text documents. Once entered into the system, material specification information is available over a local area network (LAN) instantaneously to users at headquarters and through a dial-up connection to manufacturing plants.
With the help of this system, it has been possible to handle a six-fold increase in specifications administration workload without adding staff.
Janssen, a subsidiary of Johnson & Johnson with headquarters in Beerse, Belgium, has product areas which include gastrointestinal drugs, cancer medications, antifungals, antihistamines and narcotics. Administration, marketing and research, as well as packaging development and documentation are handled at the U.S. headquarters in Washington Crossing, New Jersey. The company also has a manufacturing plant in Fort Washington, Pennsylvania which produces injectable products and another in Gurabo, Puerto Rico, which operates under the name of OMB Pharmaceutical Partners, Inc.
The large expansion in the company's product line in the last several years has come mainly from new products and expansion of existing products. For example, Nizoral antifungal cream has been expanded to include five different pack-outs including two different 2-, 10-, 15-, and 30-gram containers. Each of the new products requires a considerable amount of documentation. It was estimated that the number of packaging components numbers would be increasing to the 800-1000 range when the product development and documentation process even more critical than usual.
As the new products started to come on line, the packaging specifications department found itself buried under a mountain of paper. The documents had to be drafted with a word processor and then pass through an approval process which added considerable additional paper handling and delays. Every new document or change to existing documents had to be reviewed by the packaging development, purchasing and regulatory groups as well as several other departments.
In the past, the approval process was initiated by attaching a cover sheet to the specification listing the various people that needed to approve it and sending it to the first person on the list who reviewed and signed it and sent it along to the next person. This process normally took at least a few weeks but could extend considerably longer if it ran into a snag along the way - such as a person being out of town or the document being misplaced under a stack of papers on someone's desk. It also presented difficulties for managers who are part of the approval process.
Since the process was based entirely on paper, it was often necessary for documents to be faxed around the country in an effort to reach a manager on a trip or sometimes, even, for trips to be interrupted to pick up documents requiring immediate attention. After approval, the documents were shipped by mail to the different groups which were each responsible for filing the new documents and discarding the old ones.
Another problem with the old system was the average one month delay from the time the specification change was initiated until the new documentation was in place at the group. There was no way for the groups to find out if a change was in progress so the situation frequently arose where people were working with old documents during the one-month time lag that it would typically take for new documents to be created, approved, delivered and filed. In some cases, once the change was finally received, overtime or rush charges were required in order to meet manufacturing deadlines. In other cases, purchase orders had already been placed with the old specifications and they had to be canceled and replaced with updated versions. In essence, valuable time was being lost in correcting errors instead of doing things right the first time.
Another problem arose from the fact that documents were sometimes misplaced in the manufacturing plants or, being of the delays inherent in the old system, manufacturing personnel did not have confidence in the documents in their files. This meant that the packaging department had to field a steady stream of inquiries which provided a distraction from the main job of creating new documentation. On the average, 30 pages per week of documents were faxed from headquarters to the Puerto Rico plant.
Packaging engineers at the company had long recognized the problem but were not able to find a promising solution until about two years ago when they heard about PC-SPECS. This software package, which was just being introduced, was reportedly the first PC-based program to specifically address purchased materials specifications documentation. The uniqueness of the product rests in its ability to seamlessly integrate into a single system information in multiple media formats, including CAD drawings, graphics and artwork, pallet diagrams and text-based support documents - in a multi-user environment. The package is sold as an off-the-shelf system with customization added as necessary to match existing control procedure requirements. Features of the program include: maintaining records of all changes made to specifications; ability to search for specifications matching specific parameters; specifications can be maintained according to finished product or individual components; control over user access is provided through use of passwords and security access level assignments on an individual user basis; palletization software solution files can be imported into the system; and the electronic signature capability for approval purposes is included, removing the need to route paper copies.
One of the most important benefits of the new system was the time saved in creating specification documents. Using a word processor, a considerable amount of the time was required just to format the document. With the specifications database, all that needs to be done is to fill in relevant information on a standardized form which is much quicker. Normally, a clerk would start by copying a similar document which the packaging engineer would then mark with the required changes. With PC-SPECS, the engineer can search to find the document to be copied and only new information needs to be entered.
A recent example was changing one component on each of four put-ups which required four packaging specifications and four bills of materials. Making the change, changing the status and sending the document out for approval electronically took about 45 minutes. Under the old system this would have easily taken a full day because it would have required formatting the document, checking grammar and spelling, copying the document, producing a routing slip, and mailing the package. Further improvements are expected in the near future when drawings and graphic images of labels will be added to the database so that the entire specification is available on line.
Another benefit of implementing the computerized system was the streamlining of the approval process. The specification system includes all packaging specifications with a list of the people who are required to approve them before they go into effect. This makes it possible to present the proposed package changes simultaneously to everyone who needs to approve it and offers the capability of recognizing that certain participants in the process will begin their review only after one or more other parties have already approved the design.
Using the new computerized system, it is easy to determine the status of any particular approval or to produce a list of all items out for approval which indicates how long since the approval process began and who still needs to sign. Likewise, any person on the approval cycle can easily call up a list of all labels requiring their signature. With the manual approach, on the other hand, tracking down a particular routing slip requires contacting each person on the list until the slip is found. Using this approach, it is possible to route a new document through the entire approval chain in as little as an hour. Managers who are traveling can dial into the system and remotely approve the documents from long distance.
Another major benefit of the new system is improved communications with remote manufacturing locations. The remote sites can now establish a dial-up communications link with the specifications database in New Jersey. As soon as a specification is updated, the information is available to the remote sites. Thus, the need to distribute and maintain paper documents is eliminated. Anyone with the proper security authorization can access the specification in seconds on their computer. Providing production personnel with correct specifications on a real-time basis has eliminated production errors caused by outdated specifications and also reduced the amount of time it takes to get a new product to market by weeks. When production calls in to query a particular specification, they receive notification if a change is in process and they have the opportunity to comment on pending changes. Production can even use the system to initiate changes which took considerably more time because they had to follow the same cumbersome process used by the packaging department to initiate changes. The packaging department also benefits because they receive far fewer phone inquiries and requests for emergency faxes.
Overall, the system reduces time required to create specifications, and simplifies and streamlines the approval process. The system provides other valuable time saving features. It allows for the provision of accurate, timely and readily accessible information throughout a company.
