- Email: [email protected]
LIMS in the manufacturing environment
Laboratory automation and information management ELSEVIER
Laboratory Automation and Information Management 31 (1995) 109-113
LIMS in the manufacturing environment Mary Hinton Applied Computer Systems, 3540 Country Ct. N., Mobile, AL 36619, USA
Received 19 April 1995; accepted 30 June 1995
Abstract The type of laboratory that implements a LIMS is very important in determining the requirements of the LIMS. This article focuses on the requirements for a manufacturing LIMS. The objectives of a manufacturing laboratory that a LIMS should support are presented. Issues that should be considered in the initial planning stage of implementing a manufacturing LIMS are discussed. Functional requirements for a manufacturing LIMS examined in the article are the ability to: (1) handle various material types, (2) grade products, (3) allow flexibility in test method configuration, (4) handle data limits and variable sets of data. (5) revise and track test methods and specifications, and (6) maintain a customer and/or supplier database. Keywords: LIMS; Manufacturing; Implementation; Function; Planning
1. Introduction The type of laboratory that implements a LIMS is very important in determining the requirements of the LIMS. For example, a testing services laboratory has a far different approach to managing laboratory information than a manufacturing laboratory. In a testing services laboratory the cost of each test performed is a major consideration in company profitability, whereas the cost of a test in a manufacturing environment is usually minuscule compared to the price of producing the product itself. So schedules, worklists, and other cost reducing measures are very important in a testing services LIMS, but are not the primary emphasis in a manufacturing LIMS. Historically, the functional requirements of a LIMS have been primarily directed at satisfying the needs of testing services laboratories. When the LIMS
vendor entered the manufacturing environment, the same testing services LIMS were used. Consequently, it is not surprising that current LIMS often fall short in meeting the process requirements placed on the manufacturing laboratory. This article will focus on the requirements for a manufacturing LIMS.
2. Objectives in a manufacturing laboratory The manufacturing laboratory's primary function is to contribute to the overall success of producing and selling quality grade products. In today's fastpaced world, the quality of a product must be continually improved to stay competitive [1]. Thus, the manufacturing laboratory is expected to • manage data throughout the life cycle of products • aid in process control decisions • assure product specifications
0925-5281/95/$09.50 © 1995 Elsevier Science B.V. All rights reserved SSDI 0925-5281(95)00018-6
110
M. Hinton/ LaboratoryAutomation and Information Management31 (1995)109-113
3. Manage data throughout the life cycle of products The life cycle of products parallels the life cycle of process samples entering the laboratory. The life cycle of the product may be divided into the following categories for the purposes of a LIMS • raw materials to create the product • work-in-progress product • final product. The manufacturing LIMS needs to handle samples representing these various stages of the product. Beginning with the raw material to make the product, samples of the material are sent to the laboratory, logged-in, tested, and log-out/graded. The LIMS database should store all pertinent product information, including data results, lot information, product specifications, supplier information, and units made. Some manufacturers will want to record which lots (batches) of raw material were used to make which lots (batches) of product and which work-inprogress results correspond to which product lots (batches). Traceability of sample results and sample information is important in tracking the life cycle of products.
4. Aid in process control decisions Work-in-progress data results are often used to make on-the-spot process control decisions. The LIMS can be used to check test parameters before the laboratory gives approval to process control to proceed to the next process step. Also the LIMS must either provide a module for statistical analysis of final-product results or provide export ability to statistical packages to aid in future process control decisions.
5. Assure product specifications Often product sample results need to be compared to numerous specifications. Specifications are determined by many factors, including the following: (1) the tests performed, (2) which product grades (brands), the lot (batch) is checked against for conformity, (3) customer specifications and (4) internal
specifications. The LIMS should not allow an offspec or incorrect product to be shipped to a customer. The LIMS can check the customer information in the database to make sure that the customer purchases the product on the bill of lading and the customer's specifications have been met for the particular product lots listed for shipment. Only then using the customer's specifications should the LIMS print the COA (Certificate of Analysis). 5.1. Initial planning stage of LIMS implementation
Although the LIMS is controlled by the laboratory, the information maintained by the LIMS will be consumed by many areas outside the laboratory. This includes process control, shipping and receiving, customer service, material handling and inventory, quality assurance, and management. During the initial planning stage, the needs of both the laboratory and the consumers of the laboratory data must be analyzed to determine the functional requirements of a manufacturing LIMS [2]. For instance, the shipping department must decide which products can be sold to which customer. Therefore, the shipping department should have access to the LIMS final-product test results. This department may also require the LIMS to manage bill of lading information for each shipment. On the other hand, receiving needs access to the LIMS' raw material data, since receiving must often wait for the laboratories approval before raw material can be unloaded. Even if a supplier furnishes a COA, the laboratory will often need to perform a qualitative test on the raw material. If the LIMS is expected to track the quality of raw material, it must store the COA information received from suppliers. Statistical analysis of the raw material data can be very valuable to process control in tracking down the reasons for process problems such as increased degradation or the sudden lowering of product quality. Material handling and inventory also use the final-product results stored in the LIMS. Based on these results, material handling must decide whether out-of-spec product should be: (1) reworked, (2) sold as product after receiving customer approval, (3) repackaged or relabelled as lower grade product, or (4) rejected outright [2].
M. Hinton /Laboratory Automation and Information Management 31 (1995) 109-113
A close association between the LIMS and the inventory information system is essential to answer the following questions • For each product lot logged into the LIMS, what amount of product does it represent? • How much of the lot has been sold, and conversely how much is left in inventory? • Can the product be sold as different grades of product? Since there are many consumers of laboratory information, a questionnaire addressing the needs of the laboratory and the requirements of departments using laboratory data should be circulated. This will generate interest in the project and help refine the functional requirements in the early stages where project changes are not expensive to make. The questionnaire should address the following topics [3] Materials information Locations information Sample information Sampling strategies Test method information Grades and specifications Customer/vendor information Log-in and log-out procedures Material-release procedures Material-exception procedures Reports/graphs Certificates of analyses (COAs) User access information Quality assurance procedures. The above topics are related to the way the manufacturer produces its products and conducts business. Thoughtful questions on these subjects will help model the LIMS on current business practices. A questionnaire more specific to computer software, hardware, and laboratory instruments should also be circulated to the laboratory personnel, the company's MIS (management information systems) department, and any department with an existing computer information system that may impact the design or implementation of a LIMS.This questionnaire should address the following • Operating systems • Software portability • Computer hardware • Computer networks • Databases
111
• Screen managers (also called, application framework, GUI, etc.) • Interfaces to existing information systems (e.g., inventory, material resource planning, etc.) • Data acquisition systems.
6. Data acquisition systems Data acquisition is one of the many functions that a LIMS needs to address. Using this topic as an example, some questions to ask about data acquisition systems are • If there are data acquisition systems in place, will they work with the selected LIMS? • Does the LIMS have its own data acquisition modules or can it interface to other vendors data acquisition modules? • Do the data acquisition systems adhere to standard data collection formats? • If the data collection is not automated, should some of the data collection systems in the laboratory be automated? • Which data collection systems should be automated first? To answer the last question, instruments that produce copious amounts of data would be the logical choice to automate first and interface with a LIMS. For instance, a test method requires eight injections on a gas chromatograph (GC) and the manual transcription of 30 peaks for each injection into a spreadsheet. It is easy to see that a GC data acquisition/data management system would greatly reduce the workload on the technicians and reduce data transcription errors. Some data acquisition systems collect data only, while others perform sample data management. For example, using a GC data acquisition/data management system, the laboratory personnel should be able to set up or change the calibrations for each method and analysis and decide which GC peaks to import to the LIMS. The system may be robust enough to allow the laboratory technician to recalibrate on the fly or rename peaks on the fly that have been misidentified. Unknown components may also be tracked and identified at a later time. The LIMS and data acquisition system should be tightly coupled to take full advantage of any data management performed by the data acquisition system.
112
M. Hinton /Laboratory Automation and Information Management 31 (1995) 109-113
Since a manufacturing laboratory is usually highly automated, a LIMS that can interface to data acquisition systems will greatly increase the productivity of the laboratory. The Analytical Instruments Association (AIA) is taking an active role in defining the file formats for data acquisition files. The standardization of data acquisition files by instrument vendors will help the LIMS vendor interface to other vendors' data acquisition systems.
7. Functions needed in a manufacturing LIMS Many of the functions required in a manufacturing LIMS are intrinsic to all LIMS, such as automatic calculations, range checking, fast data retrieval, and security, but a manufacturing LIMS may also be expected to • Handle various material types • Grade products • Allow flexibility in test method configuration • Handle data limits and variable sets of data • Revise and track test methods and specifications • Maintain a customer and/or supplier database.
8. Handle various material types A manufacturing LIMS must process a variety of material types, each of which may be handled very differently. Samples coming into the manufacturing laboratory represent various stages of the manufacturing process. A manufacturing LIMS should handle: (1) raw material, (2) work-in-process samples, (3) final product, (4) environmental samples, and if needed, (5) stability test samples. Consider the difference between work-in-progress and final-product samples. Work-in-progress samples may be processed at various times in the laboratory until the process meets a certain measurement in the laboratory. There may not be a certain number of replicates that have to be performed on work-in-progress samples, but rather a parameter specification must be met before the process can continue to the next stage. For example, a certain by-product must be below a specified amount before a process can continue. On the other hand, a final-product sample may have specifications on both the various mea-
surement parameters and on the number of runs (replicates) that must be performed. Each of the above mentioned material types may need to be grouped and analyzed on different sets of conditions.
9. Grade products Many manufacturers have grades or brands for the same product. A product may fail a test that is important for one customer and not important at all to other customers. For many manufacturers, the ability of a LIMS to grade products is a necessity. The manufacturer will also have his own internal specifications as to what constitutes good product. A LIMS that can test the product against more than one set of specifications can help maximize profits by selling properly graded product to customers. If the product can be sold as a higher grade it should not be inadvertently sold to a customer that only requires a lower grade.
10. Allow flexibility in test method configuration A manufacturing laboratory is in a continually changing environment and the LIMS should allow the LIMS manager to configure test methods for the system without the need of a software programmer. A flexible LIMS can allow the LIMS manager to design test method data entry screens similar to the way the laboratory currently logs the data. Any bench sheets in-use for data calculations and data entry may often be used by the LIMS manager as the basis for the design of the test method data entry screen.
II. Handle data limits and variable sets of data Besides handling numeric and descriptive data, a manufacturing LIMS may need to handle data limits and variable sets of data. In this context, data limits are data with ' < ' or ' > ' values. Suppose that three readings are taken for a measurement: '12', ' < 10', and '11'. The LIMS should be able to handle the algebraic meaning of averaging these values. Numerically, the average would be '11', but using inequalities, the average is ' < 11' [2].
M. Hinton /Laboratory Automation and Information Management 31 (1995) 109-113
A variable set of data is defined here to be a data set that can consist of both expected and unexpected data points. An example of a variable data set would be data from a chromatogram chart, where known and unknown peaks are present. A manufacturing LIMS may need to handle variable data sets so that unknown components may be identified at a later time. Analyzing and storing unknown components can aid process control in refining the process.
12. Revise and track test methods and specifications A manufacturer is constantly striving for the competitive edge in quality of existing products and the introduction of new products. The LIMS in a manufacturing laboratory must be flexible to adapt to changes in a manufacturer's processes. The LIMS manager should be able to add a n d / o r revise test methods and specifications without having to have the system reprogrammed. Data collected using the old test methods and specifications should still be interpreted and reported for the test methods and specifications in effect at the time of sample processing. Therefore, a manufacturing LIMS must allow for test method and specification revisions, yet be able to track the method and specifications in-place at the time of data collection
[11. 13. Maintain database
a
customer
and/or
supplier
Often the manufacturing laboratory deals directly with the customers. The laboratory may be responsible in deciding what product lots to ship to a particular customer and to provide COAs customized for the individual customer. If the customer requests transmission of data results by modem or fax, the LIMS should be able to send the COA directly to the customer by modem or fax software. To automate customer reports, the LIMS needs to maintain a
113
customer database that may include company name, addresses, contact names, which products are purchased by a customer, and customer product specifications [2]. To store COA information from suppliers, the test results and the supplier's name are entered at log-in. To correlate these COA raw material tests results and any tests performed by the laboratory with the supplier information, a LIMS supplier database module is required. The information contained will be similar to the customer database and should include supplier name, address, and contacts, which raw materials are purchased from the supplier, and supplier specifications for each test performed by the supplier. Again the LIMS should be flexible enough to allow the LIMS manager to add or change information about customers a n d / o r suppliers without requiring the resources of the LIMS vendor [2].
14. Conclusion Implementing a manufacturing LIMS is a complex endeavor and the literature on functional requirements for a manufacturing LIMS has been sparse. At the present time, no single LIMS on the market will give all the functionality needed by the manufacturing laboratory, but by examining the current manufacturing environment, realistic compromises can be accepted. Any LIMS contributes to the quality assurance of laboratory data results, but a manufacturing LIMS that handles the various stages in the life cycle of products is also expected to help improve the quality of the products themselves.
References [1] M. Hinton, M.E. Sawyer and D. Davis, Am. Lab., Oct. (1992) 31. [2] M. Hinton, Laboratory Information Management Systems: Development and Implementation for a Quality Assurance Laboratory, Marcel Dekker, New York, 1995, pp. 36-53. [3] M. Hinton, Initial LIMS Planning, Applied Computer Systems, Mobile, Alabama, Company Literature, 1995.
Laboratory Automation and Information Management 31 (1995) 109-113
LIMS in the manufacturing environment Mary Hinton Applied Computer Systems, 3540 Country Ct. N., Mobile, AL 36619, USA
Received 19 April 1995; accepted 30 June 1995
Abstract The type of laboratory that implements a LIMS is very important in determining the requirements of the LIMS. This article focuses on the requirements for a manufacturing LIMS. The objectives of a manufacturing laboratory that a LIMS should support are presented. Issues that should be considered in the initial planning stage of implementing a manufacturing LIMS are discussed. Functional requirements for a manufacturing LIMS examined in the article are the ability to: (1) handle various material types, (2) grade products, (3) allow flexibility in test method configuration, (4) handle data limits and variable sets of data. (5) revise and track test methods and specifications, and (6) maintain a customer and/or supplier database. Keywords: LIMS; Manufacturing; Implementation; Function; Planning
1. Introduction The type of laboratory that implements a LIMS is very important in determining the requirements of the LIMS. For example, a testing services laboratory has a far different approach to managing laboratory information than a manufacturing laboratory. In a testing services laboratory the cost of each test performed is a major consideration in company profitability, whereas the cost of a test in a manufacturing environment is usually minuscule compared to the price of producing the product itself. So schedules, worklists, and other cost reducing measures are very important in a testing services LIMS, but are not the primary emphasis in a manufacturing LIMS. Historically, the functional requirements of a LIMS have been primarily directed at satisfying the needs of testing services laboratories. When the LIMS
vendor entered the manufacturing environment, the same testing services LIMS were used. Consequently, it is not surprising that current LIMS often fall short in meeting the process requirements placed on the manufacturing laboratory. This article will focus on the requirements for a manufacturing LIMS.
2. Objectives in a manufacturing laboratory The manufacturing laboratory's primary function is to contribute to the overall success of producing and selling quality grade products. In today's fastpaced world, the quality of a product must be continually improved to stay competitive [1]. Thus, the manufacturing laboratory is expected to • manage data throughout the life cycle of products • aid in process control decisions • assure product specifications
0925-5281/95/$09.50 © 1995 Elsevier Science B.V. All rights reserved SSDI 0925-5281(95)00018-6
110
M. Hinton/ LaboratoryAutomation and Information Management31 (1995)109-113
3. Manage data throughout the life cycle of products The life cycle of products parallels the life cycle of process samples entering the laboratory. The life cycle of the product may be divided into the following categories for the purposes of a LIMS • raw materials to create the product • work-in-progress product • final product. The manufacturing LIMS needs to handle samples representing these various stages of the product. Beginning with the raw material to make the product, samples of the material are sent to the laboratory, logged-in, tested, and log-out/graded. The LIMS database should store all pertinent product information, including data results, lot information, product specifications, supplier information, and units made. Some manufacturers will want to record which lots (batches) of raw material were used to make which lots (batches) of product and which work-inprogress results correspond to which product lots (batches). Traceability of sample results and sample information is important in tracking the life cycle of products.
4. Aid in process control decisions Work-in-progress data results are often used to make on-the-spot process control decisions. The LIMS can be used to check test parameters before the laboratory gives approval to process control to proceed to the next process step. Also the LIMS must either provide a module for statistical analysis of final-product results or provide export ability to statistical packages to aid in future process control decisions.
5. Assure product specifications Often product sample results need to be compared to numerous specifications. Specifications are determined by many factors, including the following: (1) the tests performed, (2) which product grades (brands), the lot (batch) is checked against for conformity, (3) customer specifications and (4) internal
specifications. The LIMS should not allow an offspec or incorrect product to be shipped to a customer. The LIMS can check the customer information in the database to make sure that the customer purchases the product on the bill of lading and the customer's specifications have been met for the particular product lots listed for shipment. Only then using the customer's specifications should the LIMS print the COA (Certificate of Analysis). 5.1. Initial planning stage of LIMS implementation
Although the LIMS is controlled by the laboratory, the information maintained by the LIMS will be consumed by many areas outside the laboratory. This includes process control, shipping and receiving, customer service, material handling and inventory, quality assurance, and management. During the initial planning stage, the needs of both the laboratory and the consumers of the laboratory data must be analyzed to determine the functional requirements of a manufacturing LIMS [2]. For instance, the shipping department must decide which products can be sold to which customer. Therefore, the shipping department should have access to the LIMS final-product test results. This department may also require the LIMS to manage bill of lading information for each shipment. On the other hand, receiving needs access to the LIMS' raw material data, since receiving must often wait for the laboratories approval before raw material can be unloaded. Even if a supplier furnishes a COA, the laboratory will often need to perform a qualitative test on the raw material. If the LIMS is expected to track the quality of raw material, it must store the COA information received from suppliers. Statistical analysis of the raw material data can be very valuable to process control in tracking down the reasons for process problems such as increased degradation or the sudden lowering of product quality. Material handling and inventory also use the final-product results stored in the LIMS. Based on these results, material handling must decide whether out-of-spec product should be: (1) reworked, (2) sold as product after receiving customer approval, (3) repackaged or relabelled as lower grade product, or (4) rejected outright [2].
M. Hinton /Laboratory Automation and Information Management 31 (1995) 109-113
A close association between the LIMS and the inventory information system is essential to answer the following questions • For each product lot logged into the LIMS, what amount of product does it represent? • How much of the lot has been sold, and conversely how much is left in inventory? • Can the product be sold as different grades of product? Since there are many consumers of laboratory information, a questionnaire addressing the needs of the laboratory and the requirements of departments using laboratory data should be circulated. This will generate interest in the project and help refine the functional requirements in the early stages where project changes are not expensive to make. The questionnaire should address the following topics [3] Materials information Locations information Sample information Sampling strategies Test method information Grades and specifications Customer/vendor information Log-in and log-out procedures Material-release procedures Material-exception procedures Reports/graphs Certificates of analyses (COAs) User access information Quality assurance procedures. The above topics are related to the way the manufacturer produces its products and conducts business. Thoughtful questions on these subjects will help model the LIMS on current business practices. A questionnaire more specific to computer software, hardware, and laboratory instruments should also be circulated to the laboratory personnel, the company's MIS (management information systems) department, and any department with an existing computer information system that may impact the design or implementation of a LIMS.This questionnaire should address the following • Operating systems • Software portability • Computer hardware • Computer networks • Databases
111
• Screen managers (also called, application framework, GUI, etc.) • Interfaces to existing information systems (e.g., inventory, material resource planning, etc.) • Data acquisition systems.
6. Data acquisition systems Data acquisition is one of the many functions that a LIMS needs to address. Using this topic as an example, some questions to ask about data acquisition systems are • If there are data acquisition systems in place, will they work with the selected LIMS? • Does the LIMS have its own data acquisition modules or can it interface to other vendors data acquisition modules? • Do the data acquisition systems adhere to standard data collection formats? • If the data collection is not automated, should some of the data collection systems in the laboratory be automated? • Which data collection systems should be automated first? To answer the last question, instruments that produce copious amounts of data would be the logical choice to automate first and interface with a LIMS. For instance, a test method requires eight injections on a gas chromatograph (GC) and the manual transcription of 30 peaks for each injection into a spreadsheet. It is easy to see that a GC data acquisition/data management system would greatly reduce the workload on the technicians and reduce data transcription errors. Some data acquisition systems collect data only, while others perform sample data management. For example, using a GC data acquisition/data management system, the laboratory personnel should be able to set up or change the calibrations for each method and analysis and decide which GC peaks to import to the LIMS. The system may be robust enough to allow the laboratory technician to recalibrate on the fly or rename peaks on the fly that have been misidentified. Unknown components may also be tracked and identified at a later time. The LIMS and data acquisition system should be tightly coupled to take full advantage of any data management performed by the data acquisition system.
112
M. Hinton /Laboratory Automation and Information Management 31 (1995) 109-113
Since a manufacturing laboratory is usually highly automated, a LIMS that can interface to data acquisition systems will greatly increase the productivity of the laboratory. The Analytical Instruments Association (AIA) is taking an active role in defining the file formats for data acquisition files. The standardization of data acquisition files by instrument vendors will help the LIMS vendor interface to other vendors' data acquisition systems.
7. Functions needed in a manufacturing LIMS Many of the functions required in a manufacturing LIMS are intrinsic to all LIMS, such as automatic calculations, range checking, fast data retrieval, and security, but a manufacturing LIMS may also be expected to • Handle various material types • Grade products • Allow flexibility in test method configuration • Handle data limits and variable sets of data • Revise and track test methods and specifications • Maintain a customer and/or supplier database.
8. Handle various material types A manufacturing LIMS must process a variety of material types, each of which may be handled very differently. Samples coming into the manufacturing laboratory represent various stages of the manufacturing process. A manufacturing LIMS should handle: (1) raw material, (2) work-in-process samples, (3) final product, (4) environmental samples, and if needed, (5) stability test samples. Consider the difference between work-in-progress and final-product samples. Work-in-progress samples may be processed at various times in the laboratory until the process meets a certain measurement in the laboratory. There may not be a certain number of replicates that have to be performed on work-in-progress samples, but rather a parameter specification must be met before the process can continue to the next stage. For example, a certain by-product must be below a specified amount before a process can continue. On the other hand, a final-product sample may have specifications on both the various mea-
surement parameters and on the number of runs (replicates) that must be performed. Each of the above mentioned material types may need to be grouped and analyzed on different sets of conditions.
9. Grade products Many manufacturers have grades or brands for the same product. A product may fail a test that is important for one customer and not important at all to other customers. For many manufacturers, the ability of a LIMS to grade products is a necessity. The manufacturer will also have his own internal specifications as to what constitutes good product. A LIMS that can test the product against more than one set of specifications can help maximize profits by selling properly graded product to customers. If the product can be sold as a higher grade it should not be inadvertently sold to a customer that only requires a lower grade.
10. Allow flexibility in test method configuration A manufacturing laboratory is in a continually changing environment and the LIMS should allow the LIMS manager to configure test methods for the system without the need of a software programmer. A flexible LIMS can allow the LIMS manager to design test method data entry screens similar to the way the laboratory currently logs the data. Any bench sheets in-use for data calculations and data entry may often be used by the LIMS manager as the basis for the design of the test method data entry screen.
II. Handle data limits and variable sets of data Besides handling numeric and descriptive data, a manufacturing LIMS may need to handle data limits and variable sets of data. In this context, data limits are data with ' < ' or ' > ' values. Suppose that three readings are taken for a measurement: '12', ' < 10', and '11'. The LIMS should be able to handle the algebraic meaning of averaging these values. Numerically, the average would be '11', but using inequalities, the average is ' < 11' [2].
M. Hinton /Laboratory Automation and Information Management 31 (1995) 109-113
A variable set of data is defined here to be a data set that can consist of both expected and unexpected data points. An example of a variable data set would be data from a chromatogram chart, where known and unknown peaks are present. A manufacturing LIMS may need to handle variable data sets so that unknown components may be identified at a later time. Analyzing and storing unknown components can aid process control in refining the process.
12. Revise and track test methods and specifications A manufacturer is constantly striving for the competitive edge in quality of existing products and the introduction of new products. The LIMS in a manufacturing laboratory must be flexible to adapt to changes in a manufacturer's processes. The LIMS manager should be able to add a n d / o r revise test methods and specifications without having to have the system reprogrammed. Data collected using the old test methods and specifications should still be interpreted and reported for the test methods and specifications in effect at the time of sample processing. Therefore, a manufacturing LIMS must allow for test method and specification revisions, yet be able to track the method and specifications in-place at the time of data collection
[11. 13. Maintain database
a
customer
and/or
supplier
Often the manufacturing laboratory deals directly with the customers. The laboratory may be responsible in deciding what product lots to ship to a particular customer and to provide COAs customized for the individual customer. If the customer requests transmission of data results by modem or fax, the LIMS should be able to send the COA directly to the customer by modem or fax software. To automate customer reports, the LIMS needs to maintain a
113
customer database that may include company name, addresses, contact names, which products are purchased by a customer, and customer product specifications [2]. To store COA information from suppliers, the test results and the supplier's name are entered at log-in. To correlate these COA raw material tests results and any tests performed by the laboratory with the supplier information, a LIMS supplier database module is required. The information contained will be similar to the customer database and should include supplier name, address, and contacts, which raw materials are purchased from the supplier, and supplier specifications for each test performed by the supplier. Again the LIMS should be flexible enough to allow the LIMS manager to add or change information about customers a n d / o r suppliers without requiring the resources of the LIMS vendor [2].
14. Conclusion Implementing a manufacturing LIMS is a complex endeavor and the literature on functional requirements for a manufacturing LIMS has been sparse. At the present time, no single LIMS on the market will give all the functionality needed by the manufacturing laboratory, but by examining the current manufacturing environment, realistic compromises can be accepted. Any LIMS contributes to the quality assurance of laboratory data results, but a manufacturing LIMS that handles the various stages in the life cycle of products is also expected to help improve the quality of the products themselves.
References [1] M. Hinton, M.E. Sawyer and D. Davis, Am. Lab., Oct. (1992) 31. [2] M. Hinton, Laboratory Information Management Systems: Development and Implementation for a Quality Assurance Laboratory, Marcel Dekker, New York, 1995, pp. 36-53. [3] M. Hinton, Initial LIMS Planning, Applied Computer Systems, Mobile, Alabama, Company Literature, 1995.