Manufacturing Audit Trail

The value of full process traceability and product genealogy in a globally accessible and searchable format cannot be understated. Camstar's customers report that since deploying Camstar's Enterprise Platform with manufacturing audit trails that include electronic device history records (eDHR), electronic batch records (eBR) or electronic lot history records (eLHR), their traceability search efforts are shortened from weeks or months to just minutes.

The intelligence in Camstar's electronic manufacturing audit trail enables correlating product and test results with earlier processes, measurements, equipment, people, materials and specifications – regardless of where it was manufactured. The benefits of an MES with a complete self-auditing manufacturing audit trail result are:

• Dramatically improved root cause analysis

• Fast determination and containment of affected products

• Elimination of the source of problems at every site

Supply Network Genealogy

To improve product quality across the supply network, brand owners must monitor their products across all suppliers, contract manufacturers (CMs) and original design manufacturers (ODMs). Rapid access to complete supply network genealogy – from prototypes to production; across the value chain from suppliers to final manufacturing; through end users and service/returns – makes is possible to:

• Dramatically improve root cause analysis

• Quickly determine and contain affected products

• Eliminate of the source of problems throughout the supply network

Camstar's electronic supply network genealogy captures the as-manufactured hierarchy of parts on serial numbered or lot-based products and subassemblies – across the entire supply network. Automatically collecting product, component and test data make is possible to redirect engineering from time-consuming supply network genealogy data gathering tasks to high-value problem solving. This intelligence enables correlating final test results, service data and returns data with supplier, CM and ODM materials, test result and specifications.

Product genealogy across the supply chain

Do we want to use “network” or are we trying to capture different searches?

To improve product quality across the supply chain, brand owners must have instant visibility into product genealogy across the supply chain, that is, from all suppliers, contract manufacturers (CMs) and original design manufacturers (ODMs). Rapid access to the entire supply chain product genealogy – from prototypes to production; from suppliers to final manufacturing; through end users and service/returns – makes is possible to:

• Dramatically improve root cause analysis

• Quickly determine and contain affected products

• Eliminate of the source of product problems throughout the supply chain

Camstar's electronic supply chain product genealogy captures the as-manufactured hierarchy of parts on serial numbered or lot-based products and subassemblies – across the entire supply chain. Automatically collecting product genealogy, component and test data make is possible to redirect engineering from time-consuming data gathering tasks to high-value problem solving. This intelligence enables correlating final test results, service data and returns data with supplier, CM and ODM materials, test result and specifications.

Supplier Quality Analysis

Improving product quality at the source – supplier, contract manufacturer (CM) and original design manufacturer (ODM) – will result in lower costs, shorter lead times and higher customer satisfaction.

Supplier quality analysis is often limited to observing product yield at the brand owner’s incoming inspection. Although it is good information, the ideal supplier quality analysis takes place at the source: Supplier, contract manufacturer (CM) and original design manufacturer (ODM) locations – while the products are manufactured and tested.

Instant access to web-based dashboards and alerts of supplier quality and process results will yield early detection of issues, early correction, and higher yields for all parties. The dashboards can includes real-time, actual data from suppliers’ test equipment, and this parametric and attribute test data associated with each serial number and subassembly and be analyzed for quick discovery of issues. In this way, analysis of supplier quality takes place before shipment reduces costs and delays, and can eliminate most supplier audits and incoming inspections.

Where-Used Analysis

Forward and backward traceability of products, components, equipment, processes, operators and test results – across multiple sites – is necessary for comprehensive where-used analysis.

If a defective component lot is identified, forward traceability tells us “where-used,” or every sub-assembly or final product in which it is found. Likewise, if a piece of equipment or a process revision caused a nonconformance during a specific time period, where-used analysis tells us every lot or unit that was processed on it during that time. Instant access to where-used details enables fast bracketing, and precisely identifies the affected products that need to be contained.

Backward traceability complements forward traceability and where-used analysis in that it details every component, sub-assembly, equipment, process and operator that contributed to a given lot or unit.

Camstar’s complete as-manufactured audit trail spans all activities across the entire supply chain. This intelligence enables correlating test results and field data with components, equipment, processes and operators - dramatically improving root-cause analysis, and leading to proper where-used analysis, containment, and resolution.

Traceability and Correlation

Correlation of forward and backward product, components, equipment, process, operator and test result traceability – across multiple sites – is necessary for true root-cause analysis and effective resolution. These traceability data can be correlated to reveal the combination of conditions that cause a product issue.

An easily searchable database of traceability provides fast analysis for correlation, and replaces the burden of manual engineering trial and error. For example, if certain units of a product are found defective, it may not be readily apparent what manufacturing conditions they have in common. Fast computer correlation analysis might reveal that all 15 were processed on Machine 2 on Tuesdays, just before weekly PM was due. The correlation of these elements points to the need for more frequent maintenance, and is only possible with complete and accessible traceability.

Camstar’s complete as-manufactured audit trail spans all activities across the entire supply chain. This traceability intelligence enables correlating test results and field data with components, equipment, processes and operators - dramatically improving root-cause analysis, and leading to proper, containment, and resolution.

Exception Monitoring

Prevention and early detection of issues are key to improving product quality. But finding process exceptions and deviations among the plethora of data is nearly impossible. “Management by exception” requires online exception monitoring to expose variability and issues immediately, making it possible to take action before the issue becomes a product problem.

Exception monitoring is used from the shop floor to executive office. Camstar’s MES is designed to easily integrate with shop floor equipment, collecting data, tracking results and alerting on process control limits and suspect trends. Examples include:

• Operators are alerted (and stopped) when they attempt to use material, equipment or processes that are not specified for the work.

• An operator sees an SPC chart only when an out-of-control condition occurs. The same exception monitoring alert is sent to engineering.

• Production dashboards monitor throughput and yield trends, and highlight when an exception such as slow output or low yields occur.

• Management looks for exceptions in overall productivity, product mix, costly scrap and nonconformances. Exception monitoring dashboards provide clear, concise charts when results are near to or exceed tolerances.

Real-time Alerts

Prevention and early detection of issues are necessary to reduce variability and improve product quality. Real-time alerts expose variability and issues immediately, making it possible to take action before the issue becomes a product problem.

Real-time alerts are essential on the shop floor. Camstar’s MES integrates with shop floor equipment, collecting data, tracking results and alerting on process control limits and suspect trends. It systematically prevents actions that will result in non-compliance or processing errors. Examples include:

• Operators presented with a real-time alert (and stopped) when they attempt to use material, equipment or processes that are not specified for the work. The action is automatically stopped.

• Operators cannot begin work if they are not trained and certified for the operation and product. The real-time alert prevents the action.

• An operator sees an SPC chart only when an out-of-control condition occurs. The same real-time alert is sent to engineering.

SPC / SQC

Statistical Process Control (SPC) and Statistical Quality Control (SQC) are statistical monitoring and alerting methods using control charts.

SPC monitors the process, or the parameters of the machines, the equipment and the environmental conditions (such as time, speed, pressure, concentration, etc.) SPC alerts the operator and engineer when a condition over time is behaving in an out- of-control manner, such as wide swings or trending in one direction. SPC will also alert when a single instance of the condition is outside the specification limits.

SQC monitors the attributes of the physical product (dimension, performance, appearance, etc.) SQC alerts the operator and engineer when over time the attributes are trending in an out-of-control manner, such as wide swings or trending in one direction. SQC will also alert when a single instance of the attribute is outside the specification limits.

Theoretically – and typically – a stable process will produce a stable product, and thus the process should be controlled with SPC. It is still important to monitor the attributes of the product with SQC, as that is the ultimate test of product quality. A product in control implies that the process is in control.

Utilizing live production information from Camstar’s Manufacturing Execution System, Camstar provides both SPC and SQC to enable manufacturers to solve production problems before they cause a reduction in quality, yield or throughput. Engineers can configure SPC/SCQ control charts that are automatically updated when process or product quality data is collected. Operators view real-time SPC/SQC charts that provide immediate feedback, and engineers can review historical charts when analyzing specific events.

Root Cause Analysis

True root cause analysis identifies the actual source of an issue. Often, the goal for a Corrective and Preventive Action (CAPA) is to close it quickly. Since researching through incomplete and manual records for a root cause is labor intensive and time-consuming, the “analysis” frequently concludes that the root cause is “operator training” – and the problem recurs.

Effective root cause analysis can only be achieved by discipline and the leveraging of a continually growing – and accessible – knowledge base of product design, process design, manufacturing (as-manufactured and as-tested), after market returns and field service, and quality event data. Quality and product engineers need immediate access to relevant contextual data facilitates the investigation process when something goes wrong.

These data include actual manufacturing locations, product, components, equipment, processes, revisions, operators, test results, field failures – and the tools to distill them, correlate them, and drill through them – to achieve true root cause analysis. Simple to complex relationships can then be uncovered by the system and served up as potential root causes, dramatically shortening the time to true resolution.

Pattern Discovery & Drill-down

Pattern discovery requires rapid access to real-time manufacturing locations, product, components, equipment, processes, revisions, operators, test results, field failures – and the tools to distill them, correlate them, and drill-down through them.

Camstar’s Enterprise Platform provides pattern discovery through systematic analysis of its vast amounts of manufacturing and quality data that enables understanding of the interaction among variables that cause problems, so you avoid conditions that lead to undesirable outcomes. With simple drill-down, early warning indicators are revealed and root cause analysis can be effectively performed – before the conditions lead to product problems.

Supply Networks & Manufacturing Dashboards

Manufacturing and supply network dashboards provide on-demand product intelligence – from test results to yields to statistical quality control – so brand owners, manufacturers and suppliers can improve quality and productivity.

Management by exception enables quick response to out-of-compliance shifts and other events – prior to shipment throughout the supply network. Dashboards provide instant visibility into: Yield, Overall Equipment Effectiveness (OEE), Cycle Time, and Throughput.

Intelligence gathered from product quality data across the supply network and managed manufacturing allows early warnings of quality risks and the ability to diagnose the source of problems.

• Manufacturing, supplier or contract manufacturer dashboards monitor throughput and yield trends, and highlight when an exception such as delayed output or low yields occur.

• Management dashboards reveal exceptions in overall productivity, product mix, costly scrap and nonconformances. These dashboards provide clear, concise charts when results are near to or exceed tolerances.

Dashboards provide complete visibility across the supply network and enterprise – in real time and with the right visual representation – making it possible to quickly make informed decisions that impact throughput and cycle time.

Certificates of Compliance / Analysis

Suppliers and contract manufacturers can now deliver electronic Certificate of Analysis (COA) or Certificate of Compliance (COC) data to brand owners, transforming paper reports into accurate, searchable information. These are based on established mission-critical components and critical-to-quality product test specifications and limits.

Brand owners can automatically receive test results data from contract manufacturers, redirecting engineering from time-consuming data gathering tasks and incoming inspections to high-value problem solving. The test results serve as automatic Certificates of Analysis or Certificates of Compliance.

Real-time electronic Certificates of Analysis or Certificates of Compliance replace help replace supplier and contract manufacturer audits with real-time monitoring, and replace incoming quality inspections with dock-to-stock deliveries.

Test Specifications and Limits

The Camstar manufacturing model provides revision-controlled, auditable, structured definition of the product definition and associated manufacturing processes (“Design Master Record” in life sciences.) It includes workflows with approved alternate paths, step-by-step operator procedures, parametric data collection requirements with test specifications, limits and out-of-spec actions, electronic signature requirements and detailed bills of materials. By enforcing adherence to processing rules, this model is the basis for the manufacturing audit trail.

The Camstar supply network manufacturing model for suppliers and contract manufacturers defines parametric data collection requirements with critical-to-quality product test specifications and limits.

In both cases, data acquisition integrates easily with shop floor equipment, or data can be collected through simple user interfaces. The application compares results in real time to test specifications and limits, and alerts when product attributes do not meet the test specifications and limits. Units that fail test specifications and limits can be automatically placed on hold, scrapped or sent to MRB.

Mission-critical Components

The Camstar supply network manufacturing model for brand owners defines mission-critical components and critical-to-quality parametric limits for supplier and contract manufacturer deliverables. The brand owner defines test specifications and limits for these mission-critical components, and test results for the mission-critical components are monitored, providing all parties with exception alerts when results do not comply.

Deviation Management

Camstar’s deviation management (often called Nonconformance Management) solution enables the identification and documentation of quality events from any production or non-production source across the enterprise, and applies standard risk criteria to triage and route events appropriately. This deviation management immediately contains suspect material, resources, and assets; enables the necessary investigation; and enforces disposition decisions.

Nonconformance Management

Camstar’s Nonconformance Management solution enables the identification and documentation of quality events from any production or non-production source across the enterprise, and applies standard risk criteria to triage and route events appropriately. Nonconformance Management immediately contains suspect material, resources, and assets; enables the necessary investigation; and enforces disposition decisions.

Containment

Forward traceability of products, components, equipment, processes, operators and test results – across multiple sites – are necessary for rapid and accurate product containment.

If a defective component lot is identified, forward traceability tells us “where-used,” for effective containment of every sub-assembly or final product in which it is found Likewise, if a piece of equipment or a process revision caused a nonconformance during a specific time period, where-used analysis tells us every lot or unit that was processed on it during that time for rapid containment. Instant access to as-manufactured details enables fast containment or bracketing, and precisely identifies the affected products that need to be contained.

For global, multi-site containment, Camstar’s complete as-manufactured audit trail spans all activities across the entire supply chain. This intelligence enables correlating test results and field data with components, equipment, processes and operators - dramatically improving root-cause analysis, and leading to proper where-used analysis, containment, and resolution.

Quality Management and Compliance

Camstar offers a fundamentally different approach to Quality Management from traditional compliance-focused Quality Management Systems (QMS). Camstar Quality creates a closed-loop quality process that proactively monitors events from any source – including supplier issues, manufacturing nonconformances, complaints, service, and audits – across local, distributed, or outsourced operations – to identify potential problems before a quality issue occurs. Quality Management with Camstar provides rapid containment and corrective action methods to minimize the scope and impact of quality issues when they do occur.

More effective and less costly compliance is a natural outcome of the closed-loop Quality Management process.

Camstar Quality Management not only ensures compliance with corporate and industry regulations, it also enables quality programs such as Lean and Six Sigma to advance product quality and prevent adverse events.

Virtual Product Quality Audit

A virtual product quality audit is based on electronic manufacturing process enforcement and a continuous self-auditing as-manufactured device history records. A virtual product quality audit requires enforcement through automatic control of the five “Ms”: Material, machine, (hu)man, measurements and methods. This part of the virtual product quality audit reduces process variability, eliminates errors and redundant checks, removes the overhead of manual paper processes, and ensures proactive enforcement of corrective and preventive actions. It also delivers a self-auditing as-manufactured record of electronic, real-time, searchable virtual product quality audit trail of the entire manufacturing and quality process – including traceability and genealogy, exceptions, and automated data verification and product release.

Concurrent Product / Process Design

For concurrent product and process design, the MES model should provide a structured method to define and align manufacturing process plans with product design, mBOM and their requirements. This enables execution of the “R&D” product and process design concurrently with the production products and processes.

Camstar’s manufacturing process design and modeling capabilities enable concurrent product and process design early during stages, allowing more rapid and reliable transition to manufacturing during new product introductions.

With revision-controlled and auditable definitions of the production processes – including operations, specifications, routes, resources and materials – engineering and utilizing past performance of similar processes and products plus current capabilities and capacity for more rapid process optimization. Understanding of actual throughput, yield, cycle times and as-built product quality data enable more accurate capacity planning and concurrent product and process designs that can be manufactured according to core capabilities.

ECO Enforcement and Audit Trail

Camstar Manufacturing delivers global engineering change orders (ECO) immediately or as specified by an effectivity date, ensuring that new processes are adhered to. ECO enforcement is verified in the as-manufactured audit trail, which requires enforcement through automatic control of the five “Ms”: Material, machine, (hu)man, measurements and methods. The as-manufactured audit trail makes it possible to understand the impact of an ECO and the effectivity of corrective and preventive actions. The electronic, real-time, searchable as-manufactured audit trail of the entire manufacturing and quality process – including ECO revisions, traceability and genealogy, exceptions, and automated data verification and product release – is essential.

Risk Analysis

Effective global risk analysis moves from a compliance-focused process to a closed-loop risk analysis process that proactively monitors events from any source – supplier issues, manufacturing nonconformances, complaints, service and audits – to identify potential problems when or even before a quality issue occurs.

To reduce risk, data sources and events across the enterprise are monitored to allow early detection of potential problems, early trend escalation, and alerts to appropriate individuals. Each item is scanned and analyzed to identify highest risk items, which are then given highest resolution priorities.

More effective and less costly compliance is a natural outcome of the closed-loop risk analysis process.

Manufacturing Process Design

For manufacturing process design, the MES model should provide a structured method to define and align manufacturing process plans with product design, mBOM and their requirements. This enables execution of the “R&D” manufacturing process designs concurrently with the production products and processes.

Camstar’s manufacturing process design and modeling capabilities enable vetting of the manufacturing process early during stages, allowing more rapid and reliable transition to manufacturing during new product introductions.

With revision-controlled and auditable definitions of the production processes – including operations, specifications, routes, resources and materials – engineering and utilizing past performance of similarly designed manufacturing processes and products, plus current capabilities and capacity for more rapid process optimization. Understanding of actual throughput, yield, cycle times and as-built product quality data enable more accurate capacity planning process designs that can be manufactured according to core capabilities.

Discrete and Batch Processes

Camstar’s MES offers industry-specific platform configurations for the Medical Devices, Biotechnology, Solar, Electronics, Semiconductor and Metals industries to deliver specific capabilities for the industries and accelerate deployment. Camstar’s platform is designed to readily support batch, discrete and hybrid manufacturing processes.

Camstar customers can standardized on Camstar’s Enterprise Platform for batch and discrete manufacturing processes in order to provide full traceability from finished product back to raw material, and to improve root cause analysis across multiple batches and discrete devices.

Camstar has the only MES model that supports a broad diversity of manufacturing industries and batch and discrete processes – it supports very complex process workflows, high volume automated data collection, mass customization, discrete assembly, batch process, rolled products and more. The highly configurable platform adapts to the users’ business without custom code.

Camstar Manufacturing’s Audit Trail is the basis for the complete electronic as-manufactured discrete Device History Record, Batch Record or Lot History Record (eDHR, eBR, or eLHR).

Weigh and Dispense

Manufacturers that standardize on Camstar’s Enterprise Platform for their batch (weigh and dispense) and hybrid processes are ahead of the game, with proven ability to improve quality levels and shorter time to volume. They can achieve effective root-cause analysis and corrective action based on materials and processing conditions from process start (including weigh and dispense) through end product.

Camstar customers can standardized on Camstar’s Enterprise Platform for batch weigh and dispense and discrete device manufacturing processes in order to provide full traceability from finished product back to raw material, and to improve root cause analysis across multiple batches and devices. The single, integrated system gives the flexibility and configurability to meet the business needs of hybrid operations that include weigh and dispense as well as discrete device manufacturing. As a result, they have a much better understanding of weigh and dispense processes, fewer product issues, and higher yields for more reliable quality output.

Weigh and Dispense capabilities in Camstar’s MES include:

• Procedural recipe execution

• Online operator instructions

• Target weight adjustments with tolerances

• Positive weighing against targets

• Automatic weight input from scale prior to dispensing

• Assay and potency compensation

• Manual override of scale with authority

Fabrication Fab, Assembly and Test

Camstar’s leading SemiconductorSuite MES is ready to support wafer fabrication, as well as IC and discrete assembly and test operations out-of-the-box. It is powerful enough to handle high transaction volumes, and is flexible enough to meet each site’s specific needs.

Camstar’s MES enables work in process (WIP) tracking in complex workflows with hundreds of fab operations, frequent rework paths and parametric data collection. The MES supports complex routings in wafer test, die preparation, bumping, back grind, assembly and final test. Multiple products on a wafer in the fab, multi-die parts, stacked die assembly, and final test binning are all part of the solution, eliminating the need to modify the system.

Self-auditing eDHR

The self-auditing eDHR is based on electronic manufacturing process enforcement and a continuous self-auditing as-manufactured electronic device history records (eDHR). For a self-auditing eDHR, the MES must enforce through automatic control at every step of the process all of the five “Ms”: Material, machine, (hu)man, measurements and methods. This part of the self-auditing eDHR reduces process variability, eliminates errors and redundant checks, removes the overhead of manual paper processes, and ensures proactive enforcement of corrective and preventive actions.

The self-auditing eDHR prevents product from moving forward or being shipped until every element is complete and correct. The delivery of a self-auditing eDHR includes of electronic, real-time, searchable history of the entire manufacturing and quality process – including traceability and genealogy, exceptions, and automated data verification and product release.

Camstar's customers report that since deploying Camstar's Enterprise Platform with self-auditing eDHRs:

• Their traceability search efforts are shortened from weeks or months to just minutes.

• They are able to prevent processes and product issues that would have cost as much as $200,000 per occurrence.

Materials Tracking & Certification

Camstar’s MES provides electronic manufacturing process enforcement and a continuous as-manufactured audit trail. Through automatic control at every step of the process, the MES tracks, certifies and enforces all of the five “Ms”: Material, machine, (hu)man, measurements and methods.

If a defective component lot is identified, material tracking provides the forward and backward material traceability that tells us “where-used,” or every sub-assembly or final product in which it is found. Instant access to where-used details enables fast bracketing, and precisely identifies the affected products and materials that need to be contained.

Backward traceability based on material tracking complements forward traceability and where-used analysis in that it details every component and sub-assembly that contributed to a given lot or unit.

Automatic material certification and enforcement certifies that the material used in a process is specified for the process and product, has been certified for use, and not expired. Material certification reduces variability, eliminates material certification errors and redundant checks, removes the overhead of manual material certification processes, and ensures proactive enforcement of corrective and preventive actions.

Likewise, if a piece of equipment or a process revision caused a nonconformance during a specific time period, where-used analysis tells us every lot or unit that was processed on it during that time. Instant access to where-used details enables fast bracketing, and precisely identifies the affected products that need to be contained.

Equipment Tracking & Certification

Camstar’s MES provides electronic manufacturing process enforcement and a continuous as-manufactured audit trail. Through automatic control at every step of the process, the MES tracks, certifies and enforces all of the five “Ms”: Material, machine (equipment), (hu)man, measurements and methods.

If a piece of equipment or a process revision caused a nonconformance during a specific time period, where-used analysis based on equipment tracking tells us every lot or unit that was processed on it during that time. Instant access to where-used details enables fast bracketing, and precisely identifies the affected products that need to be contained and equipment that needs to be investigated.

Backward traceability based on equipment tracking complements forward traceability and where-used analysis in that it details every equipment or machine that contributed to a given lot or unit.

Automatic equipment certification and enforcement certifies that the equipment used in a process is specified for the process and product, is in a ready state, and is not overdue for maintenance or calibration. Equipment certification reduces variability, eliminates equipment certification errors and redundant checks, removes the overhead of manual equipment certification processes, and ensures proactive enforcement of corrective and preventive actions.

Operator Tracking and Certification

Camstar’s MES provides electronic manufacturing process enforcement and a continuous as-manufactured audit trail. Through automatic control at every step of the process, the MES tracks, certifies and enforces all of the five “Ms”: Material, machine, (hu)man (operator), measurements and methods.

If an operator is suspected of causing a nonconformance during a specific time period, where-used analysis based on operator tracking tells us every lot or unit that was processed by the operator during that time. Instant access to where-used details enables fast bracketing, and precisely identifies the affected products that need to be contained and operators need to be trained.

Backward traceability based on operator tracking complements forward traceability and where-used analysis in that it details every operator that contributed to a given lot or unit.

Automatic operator certification and enforcement certifies that the operator that performs a process is trained and certified for the process and product, completes the electronic signature, is in logged into the work center, and is not overdue for training and certification. Operator certification reduces variability, eliminates operator certification errors and redundant checks, removes the overhead of manual operator certification processes, and ensures proactive enforcement of corrective and preventive actions.

Electronic Work Instructions

High quality products and regulatory compliance depend on operators performing the work exactly as work instructions specify. Human error can be high when operators have to look through paper instructions, write data and dates on forms, and analyze the data for validity. Electronic work instructions remove these errors.

Camstar’s electronic work instructions are step-by-step instructions or tasks that automatically guide an operator progressively through work at a work station. The electronic work instructions are complete and enforceable.

Electronic work instructions are “structured” so that the specifications and tasks are enforceable, and the operators and their actions are traceable. Tasks in the electronic work instructions can be configured to require operator acknowledgement or specific data collection, or to simply be informational history in the manufacturing audit trail.

Operators acknowledge each task in the electronic work instructions as it is performed, either with a simple click, or with a specific “yes” entry, or by collecting detailed parametric data.

Process and Procedure Enforcement

Camstar’s MES provides electronic manufacturing process and procedure enforcement and a continuous as-manufactured audit trail. Through automatic control at every step of the process, the MES tracks and enforces all of the five “Ms”: Material, machine, (hu)man, measurements and methods (processes and procedures).

If a process or procedure revision caused a nonconformance during a specific time period, where-used analysis based on process and procedure tracking tells us every lot or unit that was processed on it during that time. Instant access to where-used details enables fast bracketing, and precisely identifies the affected products that need to be contained and processes and procedures that need to be investigated.

Automatic process and procedure enforcement certifies that the revision of the process and procedure used is specified for the product and step, and is in an approved at the current time. Process and procedure enforcement reduces variability, eliminates process and procedure enforcement errors and redundant checks, removes the overhead of manual process and procedure enforcement, and ensures proactive enforcement of corrective and preventive actions.

Quality Data Collection and Enforcement

The Camstar manufacturing model includes step-by-step operator procedures for parametric and quality data collection with test specifications, limits and out-of-spec actions.

The Camstar supply network manufacturing model for suppliers and contract manufacturers defines parametric and quality data collection requirements with critical-to-quality product test specifications and limits.

If the quality data collected reveals that the process or product does not meet specifications, action such as putting the material on hold, stopping the process or taking the equipment out of service is automatically taken.

Automatic quality data collection enforcement certifies that the revision of the quality data collection definition used is specified for the product and step, and is in an approved at the current time. Quality data collection enforcement also ensures that the product does not move to the next step until all quality data is collected and meets the specifications.

Quality data collection enforcement reduces variability, eliminates quality data collection enforcement errors and redundant checks, removes the overhead of manual quality data collection enforcement, and ensures proactive enforcement of corrective and preventive actions.

Electronic Signatures

Regulated manufacturers deploy Manufacturing Execution Systems to eliminate the burdens of paperwork, increase efficiency and improve product quality. Accompanying these systems is the FDA mandate to ensure compliant and secure electronic signatures for the manufacturing audit trail.

Camstar’s Electronic Signatures comply fully with FDA Title 21 CFR Part 11, employing robust security access, computer-generated audit trails, fraud detection, data retention and archiving, unique username/password enforcement, and electronic signature event capture.

Electronic signatures are electronically stored records that denote accountability by the signer that he or she performed a particular activity. The description of the activity and the required electronic signatures are recorded in the electronic manufacturing audit trail.

Each electronic signature entry contains the electronic signature requirements, their meaning, and how they were met, that is the names of the signers, their roles, the activity with which they were associated, and the date and time stamp.

Labeling

Accuracy, quality and compliance in manufacturing can quickly be derailed if a unit, lot or batch is lost or improperly identified. Customers and regulatory bodies insist on accurate and informative product labeling, which can be cumbersome to produce with disconnected systems.

Camstar’ accurate and timely product labeling and label printing automatically prints product and tracking labels from original specifications and real-time manufacturing data, ensuring that labeling is complete and accurate, is produced in a timely manner, and is attached to the proper unit, lot or batch.

Camstar’s label printing automatically prints product labels based on your business rules. New labels can be printed whenever characteristics of material is established or changed.

Dispatch Management

Well-executed production plans result in shorter cycle times, on-time deliveries and less demand on limited resources. Dispatch management that properly sequences manufacturing orders and work in process (WIP), coupled with automatic enforcement, makes it easy for operators to work on the right material at the right time.

Camstar’s dispatch management shows operators the work-in-process priorities prescribed by production planners and schedulers. Dispatch management eliminates guess-work by instructing the operator to work on appropriate units first. By enforcing the dispatching rules, dispatch management improves manufacturing efficiency.

Dispatch Management instructs the operator to:

• Start work in process from manufacturing orders in the sequence as defined by your dispatch management rules

• Work on units, lots or batches at each operation or work center in the sequence as defined by your dispatch management rules