During the past decade, manufacturers in the process industries have been applying automation software solutions and associated controls to reduce costs and waste, to improve the quality and consistency of their products, and to eliminate variability.
However, with many manufacturing plants now automated to the degree justified, plant managers are now targeting plant operations as a potential area where a variety of benefits can be gained in product quality, throughput and cost. This is particularly true in the specialty chemical and pharmaceutical industries where operator actions during production can have significant safety or environmental impact, and where the recording and verification of those operator actions may be a regulatory requirement.
Electronic work instructions: improving performance, achieving compliance
With the increasing implementation of electronic work instructions (EWI) in the plant floor manufacturing process, process manufacturers today are discovering an effective method for reducing variability, increasing consistency, and bringing new product to market significantly faster. Moreover, electronic work instructions are also enabling manufacturers to implement electronic record keeping solutions that meet the requirements of the 21CFR11 rule.
What are electronic work instructions?
Work instructions have long been a fixture of manufacturing in the process industries. Variously called work instructions, batch sheets, batch production records, etc, they have all served the same purpose; that is, to describe exactly what to make, and to some degree how to make it.
The instructions provide several functions for the operators on the plant floor:
* They describe the actions that the plant floor operator is responsible to do.
* They contain information specific to the materials and process parameters.
* They provide a record of the actions taken, and any discrepancies or deviations from the specifications.
An electronic version of this paper work flow is called an electronic work instruction and fulfils the same role for the operator. An operator workflow solution, based on electronic work instructions, seeks to automate the production paper batch records, simplify the collection of information, consolidate the reporting of the batch, and most importantly, synchronise operator actions with the automation of the batching system.
The value proposition for electronic work instructions
Electronic work instructions have two distinct, yet very relevant value propositions depending on whether an industry is regulated by the cGMPs (current good manufacturing practices) or not.
cGMP regulated industries
For industries regulated by cGMPs, the value case is clear. These manufacturing operations are required to define and enforce a sequence of operations that operators follow in the manufacture of a product. These manufacturers must also maintain documentation to prove that the exact sequence was executed within specification, with any deviations noted. This has been the area, historically, where electronic work instructions have flourished in manufacturing, providing a major piece of the value for MES packages.
To understand this value, consider the requirements to manufacture a product without electronic work instructions under the cGMPs. First, a set of paper instructions must be prepared from an approved master document, and those paper instructions are then customised for the specifications of the particular batch. This set of paperwork would typically be around a 100 pages in length.
These pages are then passed to operators who execute each instruction, record data and sign each line as required, while noting any deviations. When the product is complete, it is moved into quarantine. The product cannot be sold until it is released from quarantine. The quarantine release process involves circulating that same set of 100 pages around various departments, such as plant management, maintenance, QA, etc, for approval.
Value proposition: non-regulated industries
The value propositions for non-regulated manufacturers in the evolving 'new manufacturing' world are just as dramatic as those in regulated industries.
Stable manufacturing execution and predictable quality are the keys to supply chain performance, particularly in an eManufacturing environment where realtime information is providing decision support to the business functions. Industry analyst advanced marketing research has conservatively estimated that 40% of product variability relates to practices and procedures performed on the shop floor. This variability is directly related to the efficiency, yield and quality of the products produced. Automation only provides consistent process control. As plants become more automated, a point of diminished returns is reached where better control no longer delivers 'better, faster, cheaper' manufacturing. At this point, the effect of inconsistent operator actions becomes magnified. The implementation of electronic work instructions provides a mechanism to 'automate' the operator, and represents the next level of cost savings on the plant floor.
The second major benefit of electronic workflow instructions for non-regulated industries derives from the product genealogy. As recent history has shown, catastrophic product failures, coupled with the inability to determine the root cause - and hence reduce the scope of a recall - can significantly affect the viability of even global manufacturers with brands that are household names.
Four pieces of data are needed to provide a full accounting for how a product is made:
* Raw materials used.
* Equipment used.
* The process parameters for that equipment.
* Who did what and when.
The latter part - 'Who did what and when' - is the part that an electronic work instruction satisfies, providing a record of specific actions that are traceable to individual operators. By using iWorkInstruction, manufacturers can verify the sequence of operations, critical set points and deviations from specifications. This then becomes the critical 'fourth leg' of genealogy.
Benefits of electronic records and signatures
In their comments to the FDA regarding their implementations of Electronic Records and Signatures, process manufacturers identified a number of key benefits that are achieved by electronic work instructions, both for manufacturers and the FDA, including:
* Increasing the speed of information exchange.
* Cost savings from the reduced need for storage space.
* Reduced errors.
* Improved data integration and data trending.
* Product improvement.
* Manufacturing process streamlining.
* Improved process control.
* Reduced vulnerability of electronic signatures to fraud and abuse.
* Job creation in industries involved in these technologies.
Advantages of electronic records and signatures over paper-based systems:
* Automated databases enable more advanced searches of information, thus obviating the need for manual searches of paper records.
* Permitting information to be viewed from multiple perspectives.
* Permitting determination of trends, patterns, and behaviours.
* Avoiding initial and subsequent document misfiling that may result from human error.
iWorkInstruction and the FDA's 21 CFR Part 11 Rule
The Food and Drug Administration (FDA) established the 21 CFR 11 regulation (often referred to as 'Part 11' or 'The Rule') to establish criteria under which electronic records and signatures will be considered equivalent to paper records and handwritten signatures.
GE Fanuc's iBatch automation software provides enabling technology that supports compliance with 21CFR 11. This assumes that the end user's Best Practices, Corporate Policies, or Standard Operating Procedures (SOPs) are in place to enforce security measures and ensure the safeguard of electronic records and signature information. iWorkInstruction was "designed for 21 CFR 11" and can be implemented to allow records of operator actions to be stored as electronic records that meet the requirements of 21 CFR 11.
GE Fanuc's initiatives regarding 21CFR11 solutions
As a leader in providing automation solutions to process manufacturers since 1984, GE Fanuc believes that it is at the vanguard position in regard to delivering solutions designed for 21CFR11 to its pharmaceutical customers, as well as other customers in FDA-regulated industries who are affected by the rule. GE Fanuc's support initiatives include:
* iFIX/FIX 32 Security tied to Windows NT security to prevent unauthorised access to data files and operating systems.
* Participation in important industry forums addressing compliance issues.
* Creating and publishing of best practices white paper on implementing GE Fanuc products in a regulated environment.
* Partnering with major pharmaceutical companies to ensure the highest value solutions for compliance.
* Release of iWorkInstruction, an electronic work instruction software add-on for GE Fanuc's iBatch software.
* Development of iFIX product enhancements to add new functionality to support compliance.
GE Fanuc's electronic work instruction solutions
IWorkInstruction is GE Fanuc's solution for operator workflow control. The iWorkInstruction solution fully integrates operator workflow into an iBatch S88 recipe allowing the generation of a single batch report that captures both the automatic execution of the batch, as well as the manual actions and data entry.
The solution consists of three applications, the authoring tool for writing class-based work instructions, the work instruction server for managing and executing active work instructions, and the iWorkInstruction Client ActiveX control, which displays work instructions and allows the operator to interact with them.
Each work instruction is configured with its instruction, data entry requirements and its signing requirements. The instruction can be customised to be class based through the use of field codes embedded in the instructions, including the batch ID, the product code, the unit used. Hyperlinks to drawing and other documents can be directly embedded into instruction text. Data entry can be defined as static, or can be connected to information with SQL databases, or the batch control system. Each work instruction is arranged as part of a group in a block called an EIB (electronic instruction block).
The EIB server provides a single point for storage and execution of all EIBs. The EIB server supports multiple iWorkInstruction clients. An instruction locking mechanism means that while many can view an EIB, only one person at a time can work on it, to prevent errors and data over writes.
The iWorkInstruction client control runs within the iFIX workspace, or an HTML page in a Web browser, and displays a list of active EIBs. It allows the operator to select and lock an EIB and then enter data and sign instructions. Security for signing of instructions is provided via domain or local node operating system security, on a group basis.
Conclusion
By implementing electronic work instructions (EWI) in the manufacturing process, manufacturers in the process industries today are achieving a number of critical business goals, including the ability to reduce variability, increase consistency, improve communication, reduce costs and bring new products to market significantly faster. Moreover, electronic work instructions are also enabling manufacturers to implement electronic record keeping solutions that meet the requirements of the 21CFR11 rule. As the FDA continues to strictly enforce the rule, and as manufacturers continue to face tougher, highly agile competition from all corners of the globe, electronic work instructions is a powerful solution that will enable market leading manufacturers to respond faster to ever-changing market demands and more easily comply with regulatory requirements.
For more information contact Daniel Coetzee, GE Fanuc Automation, 082 453 301, [email protected]
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