Pharmaceuticals, medical devices, diagnostics, food & beverage and cosmetics are all examples of industries subject to intensive government regulations. Stringent documentation is required to assure that processes and procedures are correctly executed in order to assure the safety and quality of the end product. Through the use of electronic records, in combination with other manufacturing operations management tools, companies can ensure compliance while also realizing major efficiency and productivity improvements.
Compliance the hard way
Some of the most common reasons for non-compliance include inadequate documentation of procedures and not following documented procedures and controls correctly. This points to an unmet need on the factory floor when it comes to the access and use of standard procedures and instructions, as well as providing an easy way to document work that has been completed.
Many plants still have a large number of paper procedure documents. Making sure these are accessible and up to date can be a challenge. Likewise, many plants have a large number of log books or paper records that are manually completed by operators, supervisors, and QA personnel. There is no assurance that all tasks and associated records are completed on time, that the records are legible, or that they are complete.
Paper records must also be reviewed by either a supervisor or quality person after they have been completed. So, there is a tremendous time investment in collecting, reviewing, and investigating non-compliances. Furthermore, without any electronic linkage there is no ability to connect the dots to drive real improvement in the business or production processes.
Electronic records deliver EFFICIENCY + COMPLIANCE
Replacing paper-based systems with an electronic records solution can lead to major efficiency gains. And by connecting the process via MOM (Manufacturing Operations Management) software you can completely change the complexion of your operations, not only from a compliance viewpoint, but also from a continuous improvement and real-time analysis viewpoint.
Utilizing electronic records in this way can facilitate:
Reduce requirements for human interaction and data entry.
Control of, and access to, SOPs
Immediate computer access to the relevant SOP for the current process. No risk of an out-of-date version. No time spent hunting for the paper records.
Computer validation of data at the point of collection assures that there is never a situation where information is missed, illegible, or out of range of acceptable values.
Computer driven task management
Assures that every required check is carried out on time.
If checks are missed or quality goes out of control, immediate email alerts and text messages will be sent to key managers. This provides a real-time problem solving, management by exception environment.
Dashboards can be installed on big screen TVs and accessed on portable devices that improve communications between all personnel involved. For example, if a production line is stopped because they are waiting for approval of a first article from the quality department, that information will be immediately available to all. In addition, when quality approves the sample, which can be incorporated in a workflow, that will immediately notify the line operator that there sample is approved and they can begin production.
Rapid access to electronic records
In the event of a customer complaint or other investigation, no time is wasted hunting through file cabinets. All data is immediately available in a relational database.
Many companies end up scrapping or reworking a lot of product that could have been saved, had it been determined that the process was heading out of control, or if records existed documenting the process conditions. With a MOM software in place, real-time SPC charts can be used and linked to the alerts system. A Historian can be used to log and alert based on key process variables such as temperature and pressure remaining within the desired range.
Electronic batch records can be generated based on the collected data. Data can be collected from a combination of processing controls (PLCs, DCS, Historian), benchtop instruments (scale, torque tester, micrometer, Ph tester, Hardness tester, etc.), and manual data entry. The collection of data can be tied into display of relevant procedures and specifications thereby significantly reducing the possibility of a non-compliance observation.
Electronic data can be easily used and shared between multiple factories in the enterprise that have similar processes for internal benchmarking and sharing of best practices.
More efficient communication can be achieved with the help of electronic journals, which relate information to a date, asset, and specific type of information (component problems, unplanned maintenance, training, supervisor notes, etc.).
Taken together, the utilization of electronic records along with other tools available in MOM can have a dramatic impact on operations and provide substantial rewards for the plant team. It can help to reduce risk of violations, improve processes, reduce risk of recalls, improve throughput and customer service levels, and improve the bottom-line performance of the business.