SlideShare a Scribd company logo
ARC WHITEPAPER


SEPTEMBER 2007




                   Achieving Compliant Manufacturing Excellence
                   through Real-time Performance Management
                   and Continuous Improvement




                   Executive Summary .....................................................................3

                   Manufacturing Excellence in Regulated Industries ............................5

                   Today’s Compliance Challenges .....................................................6

                   Additional Challenges...................................................................8

                   Real-time Performance Management ........................................... 10

                   Synchronized Manufacturing Operations ....................................... 15

                   Realizing Manufacturing Excellence .............................................. 17

                   Summary ................................................................................. 19




THOUGHT LEADERS FOR MANUFACTURING & SUPPLY CHAIN
ARC Whitepaper • September 2007




                      Greg Gorbach
                      About the Author:
                      Greg Gorbach: As ARC‟s Vice President, Collaborative
                      Manufacturing and Architecture, Greg Gorbach is a thought
                      leader in Collaborative Manufacturing and provides clients in a
                      number of manufacturing vertical markets with strategic advice
                      in dealing with boundary-crossing business processes. Greg’s
                      primary areas of focus are Collaborative Manufacturing, Oper-
                      ations Management, Business Process Management,
                      Manufacturing Performance Services, and the synchronization
                      of plant systems with CRM, ERP, PLM, Supply Chain and
                      other business systems. He brings over twenty years of hands-on experience to ARC,
                      with direct experience within manufacturing organizations, as well as extensive ex-
                      perience with suppliers to manufacturers.




                       This paper was commissioned by SAP. For additional information about SAP
                                      products and services, please contact SAP at:

                                                        www.sap.com




2 • Copyright © ARC Advisory Group • ARCweb.com
ARC Whitepaper • September 2007




                 Executive Summary

                 Life Sciences manufacturers are feeling new pressure on their operations
                 from many directions. Dynamic market needs, increased compliance re-
                 quirements, more distributed manufacturing operations, rapid product
                 innovation, Lean manufacturing, and the approaching transition to new IT
                 technology all manifest themselves on the plant floor and throughout the en-
                 terprise - and often lead to pleas for new technology solutions. Compliance
                 management, integration, and data utilization are key issues to address in
                 order to improve responsiveness and performance.

                 Many manufacturing companies recognize that improving corporate perfor-
                 mance demands better synchronization with the plant floor. At the same
                 time, moving to a risk-based approach to compliance may require new sys-
                 tems and improved data visibility. For too long, manufacturing has been
                                                            isolated.    Most of the important
                                                            production data has not been easily
                                                            accessible, and is therefore not very
                                                            useful in improving performance.
                                                            Today, however, feasible solutions
                                                            are available to drive excellence in
                                                            manufacturing              performance
                                                            through better manufacturing intel-
                                                            ligence and integration.

                                                            Real-time Performance Management
                                                            (RPM) solutions acquire manufac-
Fig 1: Value Network Dynamics Drive Manufacturing           turing data in real-time, establish
Performance Requirements; Better Integration and
Data Utilization Enable Manufacturing Excellence and        the operating context for that data,
Optimal Real-time Performance                               and ensure that it is stored in a
                                                            manner that makes it accessible at
                 later times for a variety of uses. RPM facilitates the visibility of this real-time
                 manufacturing data to users throughout the enterprise, and includes tools for
                 enhanced decision support and role-based display of performance against
                 operating metrics. Event-based triggers notify all who should be informed
                 when important or unforeseen events take place. These solutions help com-
                 panies achieve a higher level of manufacturing excellence by allowing them
                 to better leverage their detailed manufacturing information.




                                                   Copyright © ARC Advisory Group • ARCweb.com • 3
ARC Whitepaper • September 2007




                      In many companies, it falls to IT to envision new business possibilities in
                      concert with the technologies needed to realize them. At the same time, the
                      usual job of reducing the cost of doing business through increased efficiency
                      and productivity cannot be ignored. This paper outlines how modern solu-
                      tions can support both strategies at the same time.


                     Sample Business Challenges                   Strategies

                     Healthcare marketplace changes increa-       Drive efficiency to world-class levels;
                     singly are constraining prices and hence     for example, from 60% to 85% by bet-
                     profitability                                ter utilizing manufacturing data

                     Manufacturing to high quality standards;     Achieve significant improvement in First
                     need to reduce the “cost of quality” and     Pass Yield and OEE by improving visi-
                     improve productivity                         bility of quality data

                     Increase competitive advantage by driv-      Reduce operation costs through in-
                     ing down production costs and COGS           creased yield and efficiency; reduce
                                                                  material waste; avoid expensive peak
                                                                  outsourcing of manufacturing and dis-
                                                                  tribution by improving utilization of
                                                                  existing plant and facilities

                     Regulations seek to establish that each of   Document that Standard Operating Pro-
                     “5 Ms” (Man, Machine, Materials, Method,     cedures (SOPs) are followed by certified
                     and Measure) has been used appro-            operators on certified equipment, and
                     priately during manufacturing.               that approved manufacturing route, Bill
                                                                  of Materials (BOMs), recipes, and work
                                                                  instructions or manufacturing bills are
                                                                  used.

                     Need to continuously improve margins         Reduce operation costs through in-
                     and cost structure in core businesses to     creased yield and efficiency
                     fund product development and growth in
                     new markets

                     Imperative to improve competitive posi-      Reduce or eliminate non-value added
                     tion through innovation. In order to get     work to free up time for innovation by
                     to the next level, need creative solutions   providing data and analysis tools. Pro-
                     and improvements to the manufacturing        vide broad information visibility and
                     process.                                     analytics to spark innovative ideas.

                     Our Balanced Scorecard methodology           Provide real-time manufacturing per-
                     needs information from sources outside       formance information to corporate
                     our ERP system                               performance systems.

                     Our Six Sigma methodology has become         Automate the Six Sigma Control Plans
                     ingrained in our culture, but our Six Sig-   and provide real-time, exception-based
                     ma Control Plans have a limited value        notifications to owners so they can take
                     because they exist as a spreadsheet or       immediate action.
                     Word document and are difficult to ad-
                     here to.

                     To maintain and improve responsiveness       Increase data utilization: move from
                     and customer satisfaction, Plant opera-      data collection, to performance visibility
                     tions needs to be better integrated with     and analytics, to closed-loop business
                     business systems and the supply chain        scenario deployment

                     Table 1: Today’s Business Challenges Require Strategies Based on Better
                     Utilization of Manufacturing Data.

4 • Copyright © ARC Advisory Group • ARCweb.com
ARC Whitepaper • September 2007




Manufacturing Excellence in Regulated
Industries

Bio-pharmaceutical or medical device manufacturers can achieve compliance
with FDA and EU/ISO regulations by focusing on specific processes that in-
fluence product quality and safety. High-risk processes can be identified
using a scientific risk-based assessment, an approach supported by regulato-
ry agencies and industry.         By focusing on manufacturing excellence,
manufacturers can reduce the cost and time needed to achieve and maintain
compliance. A manufacturing performance excellence focus yields better
production management and recordkeeping, documented compliance with
regulations, and profitability, flexibility, and quality [Table 1].

Compliant Manufacturers in the Life Sciences industry pursue excellence in
manufacturing operations. Comparable to ARC‟s Collaborative Manufacturing
Management, SAP‟s Compliant Manufacturing is a vision for how companies
participate in an ecosystem or business network, are able to leverage the
network‟s cumulative ability to plan and anticipate demand and supply, ex-
ecute plans efficiently and effectively, comply with appropriate regulations,
sense meaningful events in real-time, and respond to and learn from ever-
changing business conditions.

Manufacturing Excellence is a critical aspect of compliant manufacturing op-
erations for regulated industries. Excellent performance is characterized by
the ability to react quickly to changing marketplace conditions, to dynamical-
ly reflect these changes in production targets, and to efficiently and reliably
achieve these targets. It also requires ongoing cost reductions and quality
improvement.

In order to achieve manufacturing excellence, manufacturers need to manage
based on real-time performance information. Grounded in operations, Real-
time Performance Management (RPM) encompasses the processes, metho-
dologies, metrics, systems, and information needed to measure and manage
the performance of a manufacturing organization. RPM places particular
emphasis on: acquiring and using real-time, plant level, performance and
operating data; providing actionable intelligence based on analytics, event
triggers, and visibility; KPI support; and, integration to business systems.
RPM provides the real-time plant level information needed by the planning
and financial reporting/analysis functions of Corporate Performance Man-
agement systems.



                                  Copyright © ARC Advisory Group • ARCweb.com • 5
ARC Whitepaper • September 2007




                       Today’s Compliance Challenges

                       With expanding regulatory initiatives [Table 2] and tighter enforcement poli-
                       cies, bio-pharmaceutical and medical device manufacturers need to have a
                       better view of manufacturing data as well as business processes that span
                                                  departments and applications. They need to en-
Regulated          Applicable                     force manufacturing best practices, while ensuring
Process Areas      Regulations
                                                  and documenting regulatory compliance. Specific
Equipment and      FDA 21 CFR Part 820.75,        regulated process areas and associated functional
Facilities         Part 211 subpart C and D
                                                  requirements for compliance are outlined here.
Production and     FDA 21 CFR Part
Process Control    820.70/72/75
                   Part 211 subpart F and I       Equipment and Facilities
                   EU/ISO 13485: 6.3, 7.5,
                                                  Life Sciences manufacturing requires a suitable en-
                   7.6, 8.2.3
                                                  vironment and specific equipment that is properly
Materials          FDA 21 CFR Part 820.
Incoming           50/80/86                       maintained and calibrated.    Specified and actual
Inspection         Part 211 subpart E             manufacturing information must be monitored and
                   EU/ISO 13485: 7.4.1,
                   7.2.2, 7.4.3, 7.5.3.2
                                                  recorded.   Compliance solutions should qualify
                                                  equipment suitability, verify environment status,
Product Design     FDA 21 CFR Part 820.30
and Definition                                    verify status of equipment and resources at time of
                                                  manufacture, support dynamic process routing, and
Validation         FDA Guidance, Part 11
                                                  assure proper maintenance and calibration.
Revision Control   FDA 21 CFR Part 820.40
                   EU/ISO 13485:4.2.3
                                                  Production and Process Control
Identity Control   21 CFR Part 11, EU cGMPs
                                                  Consider the "Five M's" for controlling manufactur-
Quality and SPC    FDA 21 CFR Part 820.250,
                   Part 211 subpart F
                                                  ing processes: Man, Machine, Materials, Method,
                   EU/ISO 13485: 8.1, 8.2.3,      and Measure. Regulations in this area seek to estab-
                   8.2.4, 8.4
                                                  lish that each has been used appropriately during
CAPA               FDA 21 CFR Parts 820.100       manufacturing.   Manufacturers must ensure that
                   Part 211 subpart F
                   EU/ISO 13485: 8.5.2, 8.5.3     Standard Operating Procedures (SOPs) are fol-
                                                  lowed by certified operators on certified equipment.
Traceability       FDA 21 CFR Parts
                   820.60/65                      It is important to document manufacturing routes,
                   Part 211 subpart J             approved Bill of Materials (BOMs), recipes, and
                   EU/ISO 13485: 7.5.3, 7.5.5
                                                  work instructions or manufacturing bills.     Some
Device, Batch      FDA 21 CFR Part 820.184
                                                  manufacturing in the life sciences industries re-
History Record     Part 211 subpart J
                   EU/ISO 13485: 4.2.4            quires solutions that integrate Statistical Process
RMA and Com-       FDA 21 CFR Parts 820.200
                                                  Control (SPC) with production.
plaint Tracking    EU/ISO 13485: 7.5.1.2.3,
                   7.5.1.3
                                                  Materials Incoming Inspection
Table 2: Major Regulated Processes in
Life Sciences Manufacturing                       The quality of the finished product depends on the



6 • Copyright © ARC Advisory Group • ARCweb.com
ARC Whitepaper • September 2007




quality of the materials used. This means tracking supplier quality ratings,
incoming quality assays and audits, material review, and integrated supplier
Corrective and Preventative Action solutions. Solutions should manage and
document raw material inventory, track raw material receipts, provide for
receiving and final acceptance, and link to LIMS systems.


Product Design and Definition
In the medical device industry, it is critical to ensure that manufacturing
stays in synch with product design changes, and that traceability extends to
design documentation. Manufacturers must document implementation of
Engineering Change Orders (ECO) and ensure that manufacturing process
documentation changes are made as of the effective date. Solutions should
provide revision controlled routings and BOMs, and generate Device Manu-
facturing Records and Device History Files.


Process Validation and Revision Control
In the bio-pharmaceutical industry, manufacturing systems and their sub-
systems must be validated with adequate change control. This requires Iden-
tity Assurance Management for access and authorization. Timely notification
of unauthorized attempts to access is also required. When changes are made,
the proper approvals are secured and changes are tracked. This requires
electronic signatures for revisions, adequate change control capability, and
the ability to ensure that proper versions of work instructions, recipes, and
SOPs are presented to the operator in production.


Identity Control
Assuring the identity of the person taking an action is critical to meeting reg-
ulatory requirements. The FDA states that there must be an environment
that ensures the "non-refutability" of a person's signature. Identity Assur-
ance Management should provide uniform procedures, a common
presentation across the platform, and a multiple application specific technol-
ogy capability.


Quality and SPC
Collecting, analyzing, and acting upon quality data is critical in any com-
pliance situation. Critical to manufacturing excellence are parametric data
collection and quality analysis tools to show yields, defects, and the like.
SPC capabilities should allow for custom SPC rules with rule violation trig-
gers to generate alerts or actions such as material holds.




                                 Copyright © ARC Advisory Group • ARCweb.com • 7
ARC Whitepaper • September 2007




                      CAPA
                      Corrective And Preventive Action (CAPA) solutions must touch all aspects
                      of manufacturing, and extend to external complaints as well as incoming ma-
                      terials and suppliers.       These systems should track and resolve non-
                      conformances, track failed acceptance criteria, provide flexible tools for the
                      design and execution of CAPA workflows, leverage SPC functionality for
                      root cause analysis, and facilitate the implementation of corrective actions.


                      Forward and Backward Traceability
                      Manufacturers must be able to track units, lots and batches from end to end, no
                      matter how complicated or simple the manufacturing process. This requires
                      unit, lot, and batch tracking and date code capabilities. Tracking lots through
                      „splits‟ and „combines‟ is also required.


                      Device or Batch History Record
                      Preparing for audits or required reporting is facilitated with an electronic
                      Device or Batch History Record.              This requires as-designed, as-
                      manufactured, and as-maintained traceability, with an easily retrievable and
                      viewable Device or Batch History Record, including links to other required
                      records associated with the Device or Batch History Record.


                      RMA, Complaint Tracking, and Adverse Event Reporting
                      Post-production services such as complaint tracking, Return Materials Au-
                      thorization, and field service must link back to manufacturing in order to
                      correct and improve the manufacturing process. RMA tracking, complaint or
                      adverse event tracking, as-maintained information capture, and integration
                      to CAPA systems should be provided.




                      Additional Challenges

                      Life Sciences manufacturers are directly feeling new pressure on their opera-
                      tions and it comes from many directions simultaneously. Dynamic market
                      requirements, increased compliance needs, more distributed manufacturing
                      operations, rapid product innovation, Lean manufacturing, and the ap-
                      proaching transition to new IT technology all manifest themselves on the
                      plant floor. Too often, the symptoms go unrecognized. For example, it may
                      be that supervisors are in a constant state of firefighting, or spending more
                      and more time expediting.       This can be related to shorter delivery promise



8 • Copyright © ARC Advisory Group • ARCweb.com
ARC Whitepaper • September 2007




 windows, faster turnaround, and more customer status inquiries. The situa-
 tion is exacerbated when plant personnel are not immediately informed
 about manufacturing exceptions, because small perturbations have a much
 larger impact when the system is running under pressure [Table 3].

 In other cases, operators may be missing their performance targets and are
 unable to meet continuous process improvement goals. Business and plant


Production Data Issues                         Remedies

Key data is in Excel spreadsheets, clip-       Collect key data electronically and make
boards, applications, production               it widely available throughout the or-
lines/equipment, and databases                 ganization

Plant production data needed by ERP is         Automatically collect and transfer plant
manually collected, often re-entered, and      data needed by ERP
manually transferred from spreadsheet to
spreadsheet as it moves from plant data
sources to the ERP system

It is very difficult to get information that   Collect and contextualize data from all
is in different departments. Different         departments electronically in real-time
systems/applications, conventions, busi-       and make it widely available throughout
ness cycles, and the like complicate the       the organization
collection and rationalization of data

It is difficult, time-consuming, and costly    Speed analysis and minimize cost by
to interpret the data and prepare              leveraging solutions that provide graph-
graphs/charts/reports that help identify       ical display, drilldown, and analytical
problems and root causes                       tools.

Shop floor technicians enter some data         Provide a simplified “front” screen for
via three, four, or five ERP screens. This     ERP data entry.
is too time-consuming and is prone to
errors.

We’ve gotten good at collecting lots of        Provide a unified, consistent view of
data – but our needs have matured and          data; visualization and analysis tools,
we need to integrate that data with other      and robust integration.
areas.

Our schedule is on a big whiteboard            Electronic schedule with extensive visi-
                                               bility, linked to real-time performance
                                               data.

We have to respond to customer Quality         Dramatically reduce the burden of re-
Notifications, even though the issues          search to answer customer quality and
may not end up being traceable to our          production inquiries. Collect and con-
products (because a number of materials        textualize data from all departments
come into play simultaneously down-            electronically in real-time and make it
stream in our customer’s manufacturing         widely available throughout the organi-
processes). It can take 5-7 days to pull       zation. Speed analysis and minimize
together the data needed to satisfy the        cost by leveraging solutions that pro-
customer                                       vide graphical display, drilldown, and
                                               analytical tools.

Table 3: A Sampling of Typical Issues Manufacturers Encounter When
Production Data is Underutilized



                                       Copyright © ARC Advisory Group • ARCweb.com • 9
ARC Whitepaper • September 2007




                      managers may be missing their budgets more frequently. Perhaps variations
                      in manufacturing performance across shifts, lines and plants are inexplicably
                      widening. These may all be signs that things are beginning to slip because
                      people are no longer able to effectively monitor, measure, analyze, control
                      and improve key performance indicators (KPIs) against targets as the pace
                      increases. Managers cannot get the information they need to measure and
                      control actual production costs against targets, and supervisors waste time
                      accessing and searching through multiple systems for needed data.

                      In mid-size and larger manufacturing enterprises, the problems are com-
                      pounded by the need to assess and improve performance across multiple,
                      possibly globally distributed, facilities and business units. Without accurate
                      and timely asset-to-asset and plant-to-plant comparison data, this is difficult
                      and impractical.

                      To address these challenges, manufacturers need solutions that allow them to
                      see and use real-time information from operations. They need solutions that
                      facilitate excellent manufacturing performance and enterprise-wide process
                      synchronization.




                      Real-time Performance Management

                      Real-time Performance Management (RPM) is a term that describes all of the
                      processes, metrics, techniques, and systems needed to measure and manage
                                    the performance of a manufacturing organization.         RPM is
                                    primarily focused at the plant level but has significant touch-
                                    points within the business systems.       It complements and
                                    extends Corporate Performance Management systems [Figure
                                    2] [Table 4].

                                    RPM solutions acquire manufacturing data in real-time, estab-
                                    lish the operating context for that data, and ensure that it is
                                    stored in a manner that makes it accessible at later times for a
                                    variety of uses. RPM facilitates the visibility of real-time man-
                                    ufacturing data to users throughout the enterprise, and
                                    includes tools for enhanced decision support and role-based
                                    display of performance against operating metrics. Event-based
  Fig 2: RPM Enables Adaptive
  Manufacturing                     triggers are also provided to notify all who should be informed
                                    when important or unforeseen events take place. These solu-



10 • Copyright © ARC Advisory Group • ARCweb.com
ARC Whitepaper • September 2007




                       tions help companies achieve a higher level of manufacturing excellence by
                       allowing them to better leverage their detailed manufacturing information.

                       Another important role for RPM solutions is to synchronize the plant floor
                       with increasingly dynamic business operations. This includes providing en-
                       terprise-wide visibility of manufacturing data, including certain operating
                       data, compliance information originating in the plant, and capacity and cost
                       data. Information needs to flow in both directions, to support work planning
                       and deployment as well as plant floor visibility of selected financial informa-
                       tion for plant floor metrics. As the need to use manufacturing data matures,
                       business processes become more automated, and closed loop scenarios begin
                       to operate between business systems and plant systems. RPM solutions pro-

Function        CPM                 RPM                 Notes

(Definition)    Corporate           Real-time           CPM is an umbrella term that describes all of the
                Performance         Performance         processes, techniques, metrics, and systems
                Management          Management          needed to measure and manage the performance
                                                        of an organization. RPM extends this to real-time
                                                        manufacturing information.

Planning        Strategic           Provide Real-time   Strategic planning, sales planning, expense plan-
                Planning, Sales     Mfg data for        ning, and risk analysis. Establish data, process, and
                Planning, etc.      Corporate Plan-     policy requirements. Budgeting, modeling, plan-
                                    ning Activities     ning, forecasting.

Financial       General Ledger,     Financial compo-    Multi-jurisdiction, reports, financial feed to metrics;
Reporting &     A/R, A/P, &         nent of plant       provide compliance info to financial sys-
Analysis        other financial     metrics;            tems/executives.
                analyses;           Compliance info
                Consolidation       from plant

Intelligence/   BI/Decision         MI/Decision         Performance indicators, reporting, analysis, dash-
Decision        Support             Support             boards, queries, alerts, notification, event/activity
Support                                                 management

Metrics/        Corporate           Production KPIs,    Metrics mgt, Planning-based metrics, Reporting,
Scorecarding    Metrics             Real-time OpX       etc. Establish targets, link metrics to underlying
                Management          Data                data, maintain and show relationships among me-
                                                        trics; drive Continuous Improvement initiatives

Real-time       n/a                 Real-time           Manufacturing data acquisition, contextualization,
Manufacturing                       Manufacturing       processing, storage
Information                         Information

Business        n/a                 Business            Closed loop business process integration; enter-
Integration                         Integration         prise-wide visibility of mfg data; Plant visibility of
                                                        selected financial info for metrics

Table 4: RPM Complements and Extends Corporate Performance Management

                       vide   the    real-time manufacturing        data,    information,      analysis,   and
                       synchronization needed to operate at a high level of manufacturing excel-




                                                        Copyright © ARC Advisory Group • ARCweb.com • 11
ARC Whitepaper • September 2007




                      lence, while supporting the corporation in excellent overall business
                      mance.

                      It is important to distinguish real-time solutions from solutions that provide
                      information on a daily or weekly basis. Real-time solutions make informa-
                      tion “actionable” at the point in time when it has the greatest potential
                      impact. This can mean the difference between one or two items and a whole
                      day‟s worth of out-of spec product taking up space, waiting for disposition
                      as scrap or rework while the customer awaits delivery of their orders. Real-
                      time solutions create ROI by exposing business opportunities that might oth-
                      erwise be lost.

                      In today‟s competitive environment, “Manufacturing Excellence” represents
                      far more than just making the machines and personnel in the plant effective.
                      Compliant Manufacturers respond proactively to unforeseen events, excep-
                      tions, and increasingly rapid changes in demand and supply. The manner in
                      which that manufacturer utilizes plant floor data determines their ability to
                      do this effectively. Historically, some data is gathered manually and other
                      data accumulates in isolated plant systems. Data gathered in this manner
                      may serve as a historical record, but is essentially unavailable for use in daily
                      operations or for continuous improvement programs.




              Fig 3: Manufacturing Excellence Depends Upon the Robust Use of Manufacturing Data




12 • Copyright © ARC Advisory Group • ARCweb.com
ARC Whitepaper • September 2007




               Many manufacturers are beginning to use systems to collect and contextual-
               ize plant data and make it visible to a variety of users. The availability of
               real-time information aids in operational decision-making and the organiza-
               tion reaps benefits in the form of efficiency and yield improvements, OEE,
               and the like. Analytical tools extend the ability to make better decisions.
               Adding event-triggered alerts reduces the reaction time for changes, failures,
               opportunities, and problems, and can significantly improve overall perfor-
               mance. Responses to certain alerts can be preordained and enforced by
               workflow solutions, further enhancing performance.

               Organizations can reap even greater gains when workflow or business
               process management tools are used to synchronize business processes across
               departments and operations and between business and plant floor systems.
               Solutions for this level of synchronization can also typically support multiple
               plants with a normalized view of performance across disparate systems. At
               the highest level, organizations can leverage the plant data/information to
               support the use of tools for modeling new business processes and the change
               management process for implementing them.




Fig 4: Improve Manufacturing Excellence by Using Data Effectively and Extending RPM to
the Enterprise and Across the Supply Network




                                              Copyright © ARC Advisory Group • ARCweb.com • 13
ARC Whitepaper • September 2007




                         Greater Than the Sum of the Parts
                         As RPM is rolled out beyond the original pilot implementation, higher levels
                         of benefits are obtained. Since RPM “snaps on” to existing systems, instead
                         of replacing or replicating them, an extended deployment can proceed at a
                         rapid pace. In addition, RPM is an approach that supports all categories of
                         metrics such as Assets, Quality, Manufacturing, and Cost, and therefore a
                         single solution can deliver performance benefits in all of these areas. When a
                         significant portion of one plant‟s operations are involved [Figure 4], that
                         plant sees better performance as well as better service to its customers. As
                         RPM is extended to multiple plants and the bulk of the enterprise, business
                         managers at all levels are empowered to make better decisions based on a
                         unified view of the distributed real-time manufacturing data. This can lead
                         to a quantum change in performance for any manufacturing enterprise. Each
                         plant has the information necessary to optimize its efforts in support of en-
                         terprise priorities.   Regional and corporate managers have accurate
                         information feeding their planning, allocation, risk management, and report-
                                                                    ing systems. The enterprise as a
                                                                    whole becomes much more adap-
                                                                    tive, and able to compete in
                                                                    previously unreachable areas.


                                                                    Real-time Manufacturing
                                                                    Data and Continuous
                                                                    Improvement
                                                                    A common use of RPM is to pro-
                                                                    vide data for the Measure phase
                                                                    of Six Sigma DMAIC processes.
                                                                    This can be implemented as data
                                                                    that appears in a quality dash-
Fig 5: SAP xMII Synchronizes Manufacturing Operations with          board.    Leading manufacturers
the Enterprise, in Heterogeneous Plant Floor IT Landscapes
                                                                    take this a step further. Instead of
                         trying to manage the Control phase with plans drawn up in Microsoft Word
                         or Excel documents, they use RPM to automate the control plans and notify
                         process owners in real time about events or exceptions so that they can im-
                         mediately take action.       This approach can have a huge impact in the
                         effectiveness of existing Six Sigma programs. Linking performance against
                         metrics with Continuous Improvement speeds the improvement cycle, which
                         creates more awareness of the value of RPM at other locations, as well as a
                         functional baseline so new installations can be deployed more quickly.



   14 • Copyright © ARC Advisory Group • ARCweb.com
ARC Whitepaper • September 2007




                                                 SAP xMII
                                                 SAP xMII connects to a wide variety of plant systems and data sources, such
                                                 as MES, DCS, HMI, Plant Historians, Laboratory systems, Maintenance sys-
                                                 tems, and other data sources [Figure 5]. It establishes the production context
                                                 for data from these systems and makes the information visible to users and
                                                                               available to other applications. It also provides
                             Category        Description                       analytical tools to aid in decision-making and
                             Data            Bi-directional data access
                                                                               integration services to facilitate connectivity to
                             Services        Metadata browsing                 business systems.
Manufacturing Integration




                                             XML-based data abstraction
                                             Connectors to external sys-
                                             tems
                                                                               SAP xMII collects and contextualizes plant data
                                                                               and make it visible to a variety of users. It sup-
                             Business        Logic
                             Logic           Integration services              ports optimal decision making by providing
                             Services        Notification services             “unified” real-time information and analytical
                                             Calculation and data
                                               transformation,                 tools.   Event-triggered alerts speed reactions,
                                             Content creation                  problem identification, and problem resolution.
                             Visualization   Charts, Grids, tickers, UI con-   It provides workflow-based responses, which
Manufacturing Intelligence




                             Services        trols,                            can be configured for certain alerts. SAP xMII‟s
                                             Dashboard components
                                                                               integration capability includes synchronizing
                             Analytic Ser- SPC/SQC (Six Sigma) analyses
                                                                               business processes across departments and oper-
                             vices         Statistical and other
                                            mathematical analyses              ations and between business and plant floor
                             Web             All services exposed as web
                                                                               systems. It scales to support multiple plants with
                             Services         services                         a normalized view of performance across dispa-
                                             Includes user-defined
                                                                               rate systems. SAP xMII plant data/information
                                              composite services
                                                                               is readily available to inform tools for modeling
Table 5: SAP xMII Core Functionality:
Manufacturing Integration and Intelligence                                     new business processes and the change man-
                                                                               agement process for implementing them.




                                                 Synchronized Manufacturing Operations

                                                 SAP xMII enables Compliant Manufacturing to drive manufacturing excel-
                                                 lence by synchronizing manufacturing operations with business systems to
                                                 deliver “one version of the truth”. Without such a solution in place, bad de-
                                                 cisions can be made due to out of date or wrong data, or because different
                                                 plants or departments have different methods and algorithms for populating
                                                 the data. At best, it wastes time to sort this all out, and delayed decisions
                                                 lead to lost profits and lost opportunities. “One version of the truth” is not
                                                 intended to imply that there must be a single data repository for all data. It



                                                                                 Copyright © ARC Advisory Group • ARCweb.com • 15
ARC Whitepaper • September 2007




                      refers to the unification of information, so that users in various roles have
                      personalized views of different aspects of the same information at the same
                      time. This unified view of manufacturing information is provided by the
                      combination of Manufacturing Intelligence – a real-time analytics engine
                      that aggregates and delivers unified visualization of events, alerts, KPIs, and
                      decision support to production personnel and appropriate other parties
                      through role-based Enterprise Portal dashboards - and Manufacturing Inte-
                      gration – a single, standards-compliant application enabling bi-directional
                      SAP ERP connectivity into real-time plant floor applications to drive efficien-
                      cy in enterprise business processes, whether in a single plant or across
                      multiple plants, business units, and regions.

                      Early adopters have identified performance improvements primarily in the
                      areas of yield, production output and Labor. Adverse events trigger quick
                      responses, so the line runs better and with more uptime. More product is
                      created faster (production) while less material is needed for a given output
                      (yield).    Labor savings come from three primary sources:       Less labor is
                      needed to clear out and dispose of bad product; a more efficient line can lead
                      to reductions in contingent labor, such as extra workers who can jump in to
                      fix problems, crank out additional work or support additional shifts; and, in
                      many cases, a significant reduction in labor occurs as the need to manually
                      collect, analyze, and chart data is eliminated.


                      How One Pharmaceutical Manufacturer Improved
                      Performance and Reduced Cost with SAP xMII
                      A large Pharmaceutical manufacturer, who is known for innovative products
                      and services, and as a leading supplier of medicines in its key markets, em-
                      ploys approximately 70,000 people in 150 countries. Having identified some
                      fairly typical performance issues, this European-based company decided to
                      introduce SAP xMII for data collection from a variety of sources, visibility at
                      operator‟s workstations, and enhanced data transfer between systems. Prior
                      to the implementation, the production staff could not easily identify issues
                      and root causes, so reaction times were slow. Too much time and labor was
                      used in manually copying and transferring data among multiple databases.
                      Too often, wrong entries were made in validation or quality-critical
                      processes. All of these issues were eliminated or improved with the imple-
                      mentation of SAP xMII.

                      The initial goals for the SAP xMII project were threefold. They sought to
                      provide time-optimized, structured visualization of production data from



16 • Copyright © ARC Advisory Group • ARCweb.com
ARC Whitepaper • September 2007




various systems. The second goal was integration between plant and enter-
prise applications. And they wanted to improve performance by automating
and enforcing pre-defined workflows and transactions in response to speci-
fied production events.

SAP xMII enabled the company to continuously display the duration of
process phases executed on certain equipment for batch production, allowing
monitoring and analysis.    Using the dashboard, users could now access
process data from an OSI PI Historian system. Batch and plant data were
displayed for a certain time slice, with all information presented in struc-
tured form. Process events were used to control the display and calculation
of minimum, maximum, and phase times, together with standard deviations.

Two plant-to-business integration scenarios were implemented. The first
involved the SAP ERP (PP PI Module), an Oracle database, an OSI PI Histo-
rian, and a SCADA operator panel. SAP process orders were combined with
product-and phase-related setpoints, stored in a SQL database, and dis-
played for plant operators. The second integration scenario was to calculate
material consumption in batch production, and transfer the value to the SAP
ERP system. In this case, the SAP ERP MM module, an OSI PI Historian, and
an Oracle database were involved. SAP xMII monitored batch completion
and obtained material consumption, plant and phase information, and PI tag
names from the Oracle database. It computed start and end times for each
material consumption, and transferred consumption values, material num-
ber, batch ID, and consumption time to SAP ERP.

This Pharmaceutical manufacturer realized significant process improvements
by Performance Monitoring and Plant-to-Business integration with SAP
xMII. They improved performance by enforcing planned reactions to events.
They reduced the manual effort involved in data collection and transfer
among databases. And they reduced cost associated with inaccurate data
entry. Based on this project, multiple additional SAP xMII were justified.




Realizing Manufacturing Excellence

Performance is the measure of manufacturing excellence, but how should
performance be measured? Unfortunately, no single measure is appropriate
for every manufacturing enterprise. Small scale deployments may focus on
OEE or cycle time, while enterprise-wide deployments require a complex set



                              Copyright © ARC Advisory Group • ARCweb.com • 17
ARC Whitepaper • September 2007




                      of coordinated metrics throughout various levels and regions. Metrics may
                      be crafted around profitability, asset utilization, quality, headcount, customer
                      satisfaction, and the like, but in the end, the performance measures currently
                      relied upon by your company and your industry are likely to be the best me-
                      trics to use to begin leveraging your manufacturing data in new ways to
                      achieve manufacturing excellence.

                      Improving the performance of the IT group can sometimes improve the per-
                      formance of the entire enterprise. With real-time data, it becomes easy to
                      prepare and distribute reports that were infeasible before. Armed with this
                      information, managers, supervisors, and operators make better decisions and
                      business performance improves. In many companies, the IT group has be-
                      come increasingly burdened by supporting homegrown and legacy plant
                      systems. An RPM solution can replace some of these applications, but a
                      more powerful strategy is “front-ending” legacy applications. With this ap-
                      proach, RPM user interfaces mimic those of legacy applications so the
                      introduction of RPM has little or no impact on the operators. Once it is in
                      place, rationalization of the underlying systems can proceed at any desired
                      pace without further impact. This in itself can justify many projects, based
                      on improving IT productivity by reducing legacy applications support costs.

                      To be sure, plant operations can benefit directly - in terms of reductions in
                      variable labor and overall production cost, together with increases in yield
                      and production output. In addition, more productive use of capital equip-
                      ment can enable manufacturers to avoid adding additional capital equipment
                      in order to get more output. It can also reduce the need to contract out man-
                      ufacturing during demand peaks.

                      Early adopters have reported dramatic changes in the effectiveness of their
                      morning meetings, which set the tone for the rest of the day. Instead of
                      working from static, dated reports, manufacturing teams begin using the live
                      RPM system at the daily meeting. Performance problems are spotted and
                      addressed immediately, using the system to drill down to individual events
                      and equipment to understand root causes. In some cases, Six Sigma or TPM
                      leaders are given action items to conduct further analysis –again leveraging
                      data from the live system.




18 • Copyright © ARC Advisory Group • ARCweb.com
ARC Whitepaper • September 2007




                    Summary

                    Manufacturers recognize that they need IT solutions designed to improve
                    performance in order to respond to dynamic market pressures, to become
                    more flexible, adaptive, and compliant to enhance competitive positioning.
                    Real-time Performance Management (RPM) solutions acquire manufacturing
                    data in real-time and synchronize the plant floor with increasingly dynamic
                    business operations. These solutions drive excellence in manufacturing per-
                    formance through better manufacturing intelligence and integration. They
                    provide enterprise-wide visibility of manufacturing data, including key op-
                    erating data, compliance information originating in the plant, and capacity
                    and cost data. These systems are relatively light touch and minimal risk, be-
                    cause they leverage existing systems and do not require expensive rip-and-
                                                      replace or replicate strategies. They are also
Category        Strategic Benefit                     relatively quick to deploy, so value is rapidly
                                                      generated. Despite this, they can have a po-
Corporate       Real-time manufacturing data
Performance     enhances corporate decision-          werful impact in two ways: by contributing to
                making and aligns the plant floor
                                                      reductions in the cost of doing business and
                with corporate initiatives
                                                      increased productivity and efficiency, and by
Competitive     Increase competitive advantage
Advantage       by driving down production costs
                                                      enabling new business processes or opportun-
                and increasing flexibility and res-   ities.
                ponsiveness

Continuous      Accelerate continuous improve-        Because RPM is an approach that spans all
Improvement     ment programs through increased       categories of metrics such as Assets, Quality,
                data velocity and process auto-
                mation                                Manufacturing, and Cost, a single solution
                                                      can deliver performance benefits in all of
Quality         Reduce the Cost of Quality with
                real-time operating data to im-       these areas. When the measurement data for
                prove margins and fund product        these metrics is linked to a continuous im-
                innovation
                                                      provement program such as Six Sigma, the
Capital         Avoid capital expenditure and
                                                      improvement cycle is accelerated and entire
Expense         peak outsourcing through better
                utilization of existing assets        operations can rapidly move to higher levels
Compliant       Real-time information and process     of performance.
Manufacturing   automation enable increased flex-
                ibility and responsiveness to         It is important to distinguish real-time solu-
                ecosystem changes
                                                      tions from solutions that provide information
Table 6: RPM Contributes to Strategic
                                                      on a daily or weekly basis. Real-time solu-
Enterprise Performance
                                                      tions make information “actionable” at the
                    point in time when it has the greatest potential impact. It can mean the dif-
                    ference between one or two items and a whole day‟s worth of out-of spec
                    product taking up space, waiting for disposition as scrap or rework while the



                                                      Copyright © ARC Advisory Group • ARCweb.com • 19
ARC Whitepaper • September 2007




                      customer goes waiting. Real-time solutions create ROI by exposing business
                      opportunities that might otherwise be lost.

                      SAP xMII enables Compliant Manufacturing for Life Sciences by synchroniz-
                      ing manufacturing operations with business systems to deliver “one version
                      of the truth” and driving manufacturing excellence. This unified view of
                      manufacturing information is provided by the combination of Manufactur-
                      ing Intelligence – a real-time analytics engine that aggregates and delivers
                      unified visualization of events, alerts, KPIs, and decision support to production
                      personnel and appropriate other parties through role-based Enterprise Portal
                      dashboards - and Manufacturing Integration – a single, standards-compliant
                      application enabling bi-directional SAP ERP connectivity with real-time plant
                      floor applications to drive efficiency in enterprise business processes, wheth-
                      er in a single plant or across multiple plants, business units, and regions.

                      SAP xMII connects to a wide variety of plant systems and data sources, such
                      as MES, DCS, HMI, Plant Historians, Laboratory systems, Maintenance sys-
                      tems, and other data sources. It establishes the production context for data
                      from these systems and makes the information visible to users and available
                      to other applications. It also provides analytical tools to aid in decision-
                      making and integration services to facilitate connectivity to business systems.

                      SAP xMII collects and contextualizes plant data and make it visible to a va-
                      riety of users. It supports optimal decision making by providing “unified”
                      real-time information and analytical tools. Event-triggered alerts speed reac-
                      tions, problem identification, and problem resolution. It provides workflow-
                      based responses, which can be configured for certain alerts. SAP xMII‟s inte-
                      gration capability includes synchronizing business processes across
                      departments and operations and between business and plant floor systems.
                      It scales to support multiple plants [Figure 6] with a normalized view of per-
                      formance across disparate systems.       SAP xMII plant data/information is
                      readily available to inform tools for modeling new business processes and
                      the change management process for implementing them.

                      For too long, manufacturing has been isolated and most important produc-
                      tion data has not been easily accessible. As manufacturing companies begin
                      their push to improve responsiveness and performance, they will find what
                      leading companies already know: Real-time Performance Management
                      (RPM) solutions drive excellence in manufacturing performance through
                      better manufacturing intelligence and integration.




20 • Copyright © ARC Advisory Group • ARCweb.com
ARC Whitepaper • September 2007




             Fig 6: SAP xMII in a Multi-Plant Context




Founded in 1986, ARC Advisory Group has grown to become the Thought
Leader in Manufacturing and Supply Chain solutions. For even your most
complex business issues, our analysts have the expert industry knowledge and
firsthand experience to help you find the best answer. We focus on simple,
yet critical goals: improving your return on assets, operational performance,
total cost of ownership, project time-to-benefit, and shareholder value.

All information in this report is proprietary to and copyrighted by ARC. No part
of it may be reproduced without prior permission from ARC.

You can take advantage of ARC's extensive ongoing research plus experience
of our staff members through our Advisory Services. ARC’s Advisory Services
are specifically designed for executives responsible for developing strategies
and directions for their organizations. For subscription information, please
call, fax, or write to:

      ARC Advisory Group, Three Allied Drive, Dedham, MA 02026 USA
      Tel: 781-471-1000, Fax: 781-471-1100, Email: info@ARCweb.com
                     Visit our web page at ARCweb.com




                               Copyright © ARC Advisory Group • ARCweb.com • 21
3 ALLIED DRIVE DEDHAM MA 02026          USA       781-471-1000

BOSTON, MA | WASHINGTON, D.C. | PITTSBURGH, PA | PHOENIX, AZ | SAN FRANCISCO, CA
CAMBRIDGE, U.K. | DÜSSELDORF, GERMANY | MUNICH, GERMANY | HAMBURG, GERMANY | TOKYO, JAPAN | BANGALORE, INDIA | SHANGHAI, CHINA

More Related Content

What's hot

Bs ppt 9
Bs  ppt 9  Bs  ppt 9
Campbell Nash Chemicals Industry
Campbell Nash   Chemicals IndustryCampbell Nash   Chemicals Industry
Campbell Nash Chemicals Industry
James Armstrong
 
Verticent Mfg Plus
Verticent Mfg PlusVerticent Mfg Plus
Verticent Mfg Plus
M-Focus
 
Ch18
Ch18Ch18
A Study of ERP Software for Sheet Metal Industries| Roadmap ERP
A Study of ERP Software for Sheet Metal Industries| Roadmap ERPA Study of ERP Software for Sheet Metal Industries| Roadmap ERP
A Study of ERP Software for Sheet Metal Industries| Roadmap ERP
Roadmap ERP
 
[CMMI Portugal 2012] CMMI ML5 Multimodel in a Portuguese company
[CMMI Portugal 2012] CMMI ML5 Multimodel in a Portuguese company[CMMI Portugal 2012] CMMI ML5 Multimodel in a Portuguese company
[CMMI Portugal 2012] CMMI ML5 Multimodel in a Portuguese company
Strongstep - Innovation in software quality
 
5 pedrohenriques-2confcmmiportugal-v2-3-split
5 pedrohenriques-2confcmmiportugal-v2-3-split5 pedrohenriques-2confcmmiportugal-v2-3-split
5 pedrohenriques-2confcmmiportugal-v2-3-split
isabelmargarido
 
Benefits and Risks in Dynamic Manufacturing Networks
Benefits and Risks in Dynamic Manufacturing NetworksBenefits and Risks in Dynamic Manufacturing Networks
Benefits and Risks in Dynamic Manufacturing Networks
imaginefuturefactory
 
The industrial model, an inevitability break for CIO’s?
The industrial model, an inevitability break for CIO’s?The industrial model, an inevitability break for CIO’s?
The industrial model, an inevitability break for CIO’s?
Capgemini
 
Catalogue of steel plant for Operational Excellence
Catalogue of steel plant for Operational ExcellenceCatalogue of steel plant for Operational Excellence
Catalogue of steel plant for Operational Excellence
Mattcons
 
C3 product design
C3 product designC3 product design
C3 product design
hakimizaki
 
Ch01 o.m.-introduction
Ch01 o.m.-introductionCh01 o.m.-introduction
Ch01 o.m.-introduction
ruchakarajgaonkar
 
Untangling Product Complexity in M&A
Untangling Product Complexity in M&AUntangling Product Complexity in M&A
Untangling Product Complexity in M&A
Michael Hu
 
A better way to manage change and transitions in project manufacturing
A better way to manage change and transitions in project manufacturingA better way to manage change and transitions in project manufacturing
A better way to manage change and transitions in project manufacturing
Julie Fraser
 
Observation report 20070720
Observation report 20070720Observation report 20070720
Observation report 20070720
營松 林
 
Quality Management System
Quality Management System  Quality Management System
Quality Management System
MetricStream Inc
 
Complexity in Industrial ERP: Getting Back to One Version of the Truth
Complexity in Industrial ERP:Getting Back to One Version of the TruthComplexity in Industrial ERP:Getting Back to One Version of the Truth
Complexity in Industrial ERP: Getting Back to One Version of the Truth
Charles Rathmann
 
Industrial model for sustainable IT efficiency
Industrial model for sustainable IT efficiencyIndustrial model for sustainable IT efficiency
Industrial model for sustainable IT efficiency
Philippe Roques
 

What's hot (18)

Bs ppt 9
Bs  ppt 9  Bs  ppt 9
Bs ppt 9
 
Campbell Nash Chemicals Industry
Campbell Nash   Chemicals IndustryCampbell Nash   Chemicals Industry
Campbell Nash Chemicals Industry
 
Verticent Mfg Plus
Verticent Mfg PlusVerticent Mfg Plus
Verticent Mfg Plus
 
Ch18
Ch18Ch18
Ch18
 
A Study of ERP Software for Sheet Metal Industries| Roadmap ERP
A Study of ERP Software for Sheet Metal Industries| Roadmap ERPA Study of ERP Software for Sheet Metal Industries| Roadmap ERP
A Study of ERP Software for Sheet Metal Industries| Roadmap ERP
 
[CMMI Portugal 2012] CMMI ML5 Multimodel in a Portuguese company
[CMMI Portugal 2012] CMMI ML5 Multimodel in a Portuguese company[CMMI Portugal 2012] CMMI ML5 Multimodel in a Portuguese company
[CMMI Portugal 2012] CMMI ML5 Multimodel in a Portuguese company
 
5 pedrohenriques-2confcmmiportugal-v2-3-split
5 pedrohenriques-2confcmmiportugal-v2-3-split5 pedrohenriques-2confcmmiportugal-v2-3-split
5 pedrohenriques-2confcmmiportugal-v2-3-split
 
Benefits and Risks in Dynamic Manufacturing Networks
Benefits and Risks in Dynamic Manufacturing NetworksBenefits and Risks in Dynamic Manufacturing Networks
Benefits and Risks in Dynamic Manufacturing Networks
 
The industrial model, an inevitability break for CIO’s?
The industrial model, an inevitability break for CIO’s?The industrial model, an inevitability break for CIO’s?
The industrial model, an inevitability break for CIO’s?
 
Catalogue of steel plant for Operational Excellence
Catalogue of steel plant for Operational ExcellenceCatalogue of steel plant for Operational Excellence
Catalogue of steel plant for Operational Excellence
 
C3 product design
C3 product designC3 product design
C3 product design
 
Ch01 o.m.-introduction
Ch01 o.m.-introductionCh01 o.m.-introduction
Ch01 o.m.-introduction
 
Untangling Product Complexity in M&A
Untangling Product Complexity in M&AUntangling Product Complexity in M&A
Untangling Product Complexity in M&A
 
A better way to manage change and transitions in project manufacturing
A better way to manage change and transitions in project manufacturingA better way to manage change and transitions in project manufacturing
A better way to manage change and transitions in project manufacturing
 
Observation report 20070720
Observation report 20070720Observation report 20070720
Observation report 20070720
 
Quality Management System
Quality Management System  Quality Management System
Quality Management System
 
Complexity in Industrial ERP: Getting Back to One Version of the Truth
Complexity in Industrial ERP:Getting Back to One Version of the TruthComplexity in Industrial ERP:Getting Back to One Version of the Truth
Complexity in Industrial ERP: Getting Back to One Version of the Truth
 
Industrial model for sustainable IT efficiency
Industrial model for sustainable IT efficiencyIndustrial model for sustainable IT efficiency
Industrial model for sustainable IT efficiency
 

Similar to Achieving Compliant Manufacturing Excellence through Real-time Performance Management

Br Us High Jump Supply Chain Advantage
Br Us High Jump Supply Chain AdvantageBr Us High Jump Supply Chain Advantage
Br Us High Jump Supply Chain Advantage
DCFaison
 
Addressing the Change and Configuration Management Imperative
Addressing the Change and Configuration Management ImperativeAddressing the Change and Configuration Management Imperative
Addressing the Change and Configuration Management Imperative
PTC
 
CH2M HILL Manufacturing Integration Consulting - 2010
CH2M HILL Manufacturing Integration Consulting - 2010CH2M HILL Manufacturing Integration Consulting - 2010
CH2M HILL Manufacturing Integration Consulting - 2010
asgtharr
 
Accenture Plant Asset Solutions Brochure
Accenture Plant Asset Solutions BrochureAccenture Plant Asset Solutions Brochure
Accenture Plant Asset Solutions Brochure
Silas O'Dea
 
White paper bharat forge by aditi & tapas july2012
White paper   bharat forge by aditi & tapas july2012White paper   bharat forge by aditi & tapas july2012
White paper bharat forge by aditi & tapas july2012
Aditi Tarafdar
 
Collaborative Discrete Automation Systems Define the Factory of the Future
Collaborative Discrete Automation Systems Define the Factory of the FutureCollaborative Discrete Automation Systems Define the Factory of the Future
Collaborative Discrete Automation Systems Define the Factory of the Future
ARC Advisory Group
 
Mobility in ERP 2011
Mobility in ERP 2011Mobility in ERP 2011
Mobility in ERP 2011
Wirehead Technology
 
CPM Identified as RPM Engine at ARC Forum
CPM Identified as RPM Engine at ARC ForumCPM Identified as RPM Engine at ARC Forum
CPM Identified as RPM Engine at ARC Forum
ARC Advisory Group
 
Trends and solutions in mes and operations management g gorbach arc orlando 2008
Trends and solutions in mes and operations management g gorbach arc orlando 2008Trends and solutions in mes and operations management g gorbach arc orlando 2008
Trends and solutions in mes and operations management g gorbach arc orlando 2008
ARC Advisory Group
 
Making Sense of Manufacturing Data - Industry 2.0 June 09
Making Sense of Manufacturing Data - Industry 2.0 June 09Making Sense of Manufacturing Data - Industry 2.0 June 09
Making Sense of Manufacturing Data - Industry 2.0 June 09
Dhiren Gala
 
Critical aspects for manufacturing
Critical aspects for manufacturingCritical aspects for manufacturing
Critical aspects for manufacturing
Gaffar Riayaz
 
Critical aspects for manufacturing to be considered
Critical aspects for manufacturing to be consideredCritical aspects for manufacturing to be considered
Critical aspects for manufacturing to be considered
Gaffar Riayaz
 
Profits Insight Client Cases
Profits Insight Client CasesProfits Insight Client Cases
Profits Insight Client Cases
ascollier
 
Cloud computing and Innovation in Manufacturing
Cloud computing and Innovation in ManufacturingCloud computing and Innovation in Manufacturing
Cloud computing and Innovation in Manufacturing
Infosys
 
Flexible and modular software framework as a solution for operational excelle...
Flexible and modular software framework as a solution for operational excelle...Flexible and modular software framework as a solution for operational excelle...
Flexible and modular software framework as a solution for operational excelle...
Thomas Schulz
 
Business Intelligence (BI) For Manufacturing - A White Paper
Business Intelligence (BI) For Manufacturing - A White PaperBusiness Intelligence (BI) For Manufacturing - A White Paper
Business Intelligence (BI) For Manufacturing - A White Paper
Dhiren Gala
 
Manufacturing
ManufacturingManufacturing
Manufacturing
Vaishali Dudhabale
 
CIOReview_Manufacturing Special Edition_TCS Article
CIOReview_Manufacturing Special Edition_TCS ArticleCIOReview_Manufacturing Special Edition_TCS Article
CIOReview_Manufacturing Special Edition_TCS Article
Amit Bhowmik
 
How to Use Technology to Support the Lean Enterprise
How to Use Technology to Support the Lean EnterpriseHow to Use Technology to Support the Lean Enterprise
How to Use Technology to Support the Lean Enterprise
FindWhitePapers
 
Batch Manufacturers Require More Robust, Dock-to-Dock Control Systems
Batch Manufacturers Require More Robust, Dock-to-Dock Control SystemsBatch Manufacturers Require More Robust, Dock-to-Dock Control Systems
Batch Manufacturers Require More Robust, Dock-to-Dock Control Systems
ARC Advisory Group
 

Similar to Achieving Compliant Manufacturing Excellence through Real-time Performance Management (20)

Br Us High Jump Supply Chain Advantage
Br Us High Jump Supply Chain AdvantageBr Us High Jump Supply Chain Advantage
Br Us High Jump Supply Chain Advantage
 
Addressing the Change and Configuration Management Imperative
Addressing the Change and Configuration Management ImperativeAddressing the Change and Configuration Management Imperative
Addressing the Change and Configuration Management Imperative
 
CH2M HILL Manufacturing Integration Consulting - 2010
CH2M HILL Manufacturing Integration Consulting - 2010CH2M HILL Manufacturing Integration Consulting - 2010
CH2M HILL Manufacturing Integration Consulting - 2010
 
Accenture Plant Asset Solutions Brochure
Accenture Plant Asset Solutions BrochureAccenture Plant Asset Solutions Brochure
Accenture Plant Asset Solutions Brochure
 
White paper bharat forge by aditi & tapas july2012
White paper   bharat forge by aditi & tapas july2012White paper   bharat forge by aditi & tapas july2012
White paper bharat forge by aditi & tapas july2012
 
Collaborative Discrete Automation Systems Define the Factory of the Future
Collaborative Discrete Automation Systems Define the Factory of the FutureCollaborative Discrete Automation Systems Define the Factory of the Future
Collaborative Discrete Automation Systems Define the Factory of the Future
 
Mobility in ERP 2011
Mobility in ERP 2011Mobility in ERP 2011
Mobility in ERP 2011
 
CPM Identified as RPM Engine at ARC Forum
CPM Identified as RPM Engine at ARC ForumCPM Identified as RPM Engine at ARC Forum
CPM Identified as RPM Engine at ARC Forum
 
Trends and solutions in mes and operations management g gorbach arc orlando 2008
Trends and solutions in mes and operations management g gorbach arc orlando 2008Trends and solutions in mes and operations management g gorbach arc orlando 2008
Trends and solutions in mes and operations management g gorbach arc orlando 2008
 
Making Sense of Manufacturing Data - Industry 2.0 June 09
Making Sense of Manufacturing Data - Industry 2.0 June 09Making Sense of Manufacturing Data - Industry 2.0 June 09
Making Sense of Manufacturing Data - Industry 2.0 June 09
 
Critical aspects for manufacturing
Critical aspects for manufacturingCritical aspects for manufacturing
Critical aspects for manufacturing
 
Critical aspects for manufacturing to be considered
Critical aspects for manufacturing to be consideredCritical aspects for manufacturing to be considered
Critical aspects for manufacturing to be considered
 
Profits Insight Client Cases
Profits Insight Client CasesProfits Insight Client Cases
Profits Insight Client Cases
 
Cloud computing and Innovation in Manufacturing
Cloud computing and Innovation in ManufacturingCloud computing and Innovation in Manufacturing
Cloud computing and Innovation in Manufacturing
 
Flexible and modular software framework as a solution for operational excelle...
Flexible and modular software framework as a solution for operational excelle...Flexible and modular software framework as a solution for operational excelle...
Flexible and modular software framework as a solution for operational excelle...
 
Business Intelligence (BI) For Manufacturing - A White Paper
Business Intelligence (BI) For Manufacturing - A White PaperBusiness Intelligence (BI) For Manufacturing - A White Paper
Business Intelligence (BI) For Manufacturing - A White Paper
 
Manufacturing
ManufacturingManufacturing
Manufacturing
 
CIOReview_Manufacturing Special Edition_TCS Article
CIOReview_Manufacturing Special Edition_TCS ArticleCIOReview_Manufacturing Special Edition_TCS Article
CIOReview_Manufacturing Special Edition_TCS Article
 
How to Use Technology to Support the Lean Enterprise
How to Use Technology to Support the Lean EnterpriseHow to Use Technology to Support the Lean Enterprise
How to Use Technology to Support the Lean Enterprise
 
Batch Manufacturers Require More Robust, Dock-to-Dock Control Systems
Batch Manufacturers Require More Robust, Dock-to-Dock Control SystemsBatch Manufacturers Require More Robust, Dock-to-Dock Control Systems
Batch Manufacturers Require More Robust, Dock-to-Dock Control Systems
 

More from FindWhitePapers

The state of privacy and data security compliance
The state of privacy and data security complianceThe state of privacy and data security compliance
The state of privacy and data security compliance
FindWhitePapers
 
Is your data at risk? Why physical security is insufficient for laptop computers
Is your data at risk? Why physical security is insufficient for laptop computersIs your data at risk? Why physical security is insufficient for laptop computers
Is your data at risk? Why physical security is insufficient for laptop computers
FindWhitePapers
 
Closing the gaps in enterprise data security: A model for 360 degrees protection
Closing the gaps in enterprise data security: A model for 360 degrees protectionClosing the gaps in enterprise data security: A model for 360 degrees protection
Closing the gaps in enterprise data security: A model for 360 degrees protection
FindWhitePapers
 
Buyers Guide to Endpoint Protection Platforms
Buyers Guide to Endpoint Protection PlatformsBuyers Guide to Endpoint Protection Platforms
Buyers Guide to Endpoint Protection Platforms
FindWhitePapers
 
VMware DRS: Why You Still Need Assured Application Delivery and Application D...
VMware DRS: Why You Still Need Assured Application Delivery and Application D...VMware DRS: Why You Still Need Assured Application Delivery and Application D...
VMware DRS: Why You Still Need Assured Application Delivery and Application D...
FindWhitePapers
 
The ROI of Application Delivery Controllers in Traditional and Virtualized En...
The ROI of Application Delivery Controllers in Traditional and Virtualized En...The ROI of Application Delivery Controllers in Traditional and Virtualized En...
The ROI of Application Delivery Controllers in Traditional and Virtualized En...
FindWhitePapers
 
The Economic Impact of File Virtualization
The Economic Impact of File VirtualizationThe Economic Impact of File Virtualization
The Economic Impact of File Virtualization
FindWhitePapers
 
Geolocation and Application Delivery
Geolocation and Application DeliveryGeolocation and Application Delivery
Geolocation and Application Delivery
FindWhitePapers
 
DNSSEC: The Antidote to DNS Cache Poisoning and Other DNS Attacks
DNSSEC: The Antidote to DNS Cache Poisoning and Other DNS AttacksDNSSEC: The Antidote to DNS Cache Poisoning and Other DNS Attacks
DNSSEC: The Antidote to DNS Cache Poisoning and Other DNS Attacks
FindWhitePapers
 
Lean Business Intelligence - How and Why Organizations Are Moving to Self-Ser...
Lean Business Intelligence - How and Why Organizations Are Moving to Self-Ser...Lean Business Intelligence - How and Why Organizations Are Moving to Self-Ser...
Lean Business Intelligence - How and Why Organizations Are Moving to Self-Ser...
FindWhitePapers
 
Inventory Optimization: A Technique for Improving Operational-Inventory Targets
Inventory Optimization: A Technique for Improving Operational-Inventory TargetsInventory Optimization: A Technique for Improving Operational-Inventory Targets
Inventory Optimization: A Technique for Improving Operational-Inventory Targets
FindWhitePapers
 
Improving Organizational Performance Through Pervasive Business Intelligence
Improving Organizational Performance Through Pervasive Business IntelligenceImproving Organizational Performance Through Pervasive Business Intelligence
Improving Organizational Performance Through Pervasive Business Intelligence
FindWhitePapers
 
IDC Energy Insights - Enterprise Risk Management
IDC Energy Insights - Enterprise Risk ManagementIDC Energy Insights - Enterprise Risk Management
IDC Energy Insights - Enterprise Risk Management
FindWhitePapers
 
High Efficiency in Manufacturing Operations
High Efficiency in Manufacturing OperationsHigh Efficiency in Manufacturing Operations
High Efficiency in Manufacturing Operations
FindWhitePapers
 
Enterprise Knowledge Workers: Understanding Risks and Opportunities
Enterprise Knowledge Workers: Understanding Risks and OpportunitiesEnterprise Knowledge Workers: Understanding Risks and Opportunities
Enterprise Knowledge Workers: Understanding Risks and Opportunities
FindWhitePapers
 
Enterprise Information Management: In Support of Operational, Analytic, and G...
Enterprise Information Management: In Support of Operational, Analytic, and G...Enterprise Information Management: In Support of Operational, Analytic, and G...
Enterprise Information Management: In Support of Operational, Analytic, and G...
FindWhitePapers
 
Enabling Strategy and Innovation: Achieving Optimized Outcomes from Planning ...
Enabling Strategy and Innovation: Achieving Optimized Outcomes from Planning ...Enabling Strategy and Innovation: Achieving Optimized Outcomes from Planning ...
Enabling Strategy and Innovation: Achieving Optimized Outcomes from Planning ...
FindWhitePapers
 
Data Quality Strategy: A Step-by-Step Approach
Data Quality Strategy: A Step-by-Step ApproachData Quality Strategy: A Step-by-Step Approach
Data Quality Strategy: A Step-by-Step Approach
FindWhitePapers
 
Data Migration: A White Paper by Bloor Research
Data Migration: A White Paper by Bloor ResearchData Migration: A White Paper by Bloor Research
Data Migration: A White Paper by Bloor Research
FindWhitePapers
 
Automating Stimulus Fund Reporting: How New Technologies Simplify Federal Rep...
Automating Stimulus Fund Reporting: How New Technologies Simplify Federal Rep...Automating Stimulus Fund Reporting: How New Technologies Simplify Federal Rep...
Automating Stimulus Fund Reporting: How New Technologies Simplify Federal Rep...
FindWhitePapers
 

More from FindWhitePapers (20)

The state of privacy and data security compliance
The state of privacy and data security complianceThe state of privacy and data security compliance
The state of privacy and data security compliance
 
Is your data at risk? Why physical security is insufficient for laptop computers
Is your data at risk? Why physical security is insufficient for laptop computersIs your data at risk? Why physical security is insufficient for laptop computers
Is your data at risk? Why physical security is insufficient for laptop computers
 
Closing the gaps in enterprise data security: A model for 360 degrees protection
Closing the gaps in enterprise data security: A model for 360 degrees protectionClosing the gaps in enterprise data security: A model for 360 degrees protection
Closing the gaps in enterprise data security: A model for 360 degrees protection
 
Buyers Guide to Endpoint Protection Platforms
Buyers Guide to Endpoint Protection PlatformsBuyers Guide to Endpoint Protection Platforms
Buyers Guide to Endpoint Protection Platforms
 
VMware DRS: Why You Still Need Assured Application Delivery and Application D...
VMware DRS: Why You Still Need Assured Application Delivery and Application D...VMware DRS: Why You Still Need Assured Application Delivery and Application D...
VMware DRS: Why You Still Need Assured Application Delivery and Application D...
 
The ROI of Application Delivery Controllers in Traditional and Virtualized En...
The ROI of Application Delivery Controllers in Traditional and Virtualized En...The ROI of Application Delivery Controllers in Traditional and Virtualized En...
The ROI of Application Delivery Controllers in Traditional and Virtualized En...
 
The Economic Impact of File Virtualization
The Economic Impact of File VirtualizationThe Economic Impact of File Virtualization
The Economic Impact of File Virtualization
 
Geolocation and Application Delivery
Geolocation and Application DeliveryGeolocation and Application Delivery
Geolocation and Application Delivery
 
DNSSEC: The Antidote to DNS Cache Poisoning and Other DNS Attacks
DNSSEC: The Antidote to DNS Cache Poisoning and Other DNS AttacksDNSSEC: The Antidote to DNS Cache Poisoning and Other DNS Attacks
DNSSEC: The Antidote to DNS Cache Poisoning and Other DNS Attacks
 
Lean Business Intelligence - How and Why Organizations Are Moving to Self-Ser...
Lean Business Intelligence - How and Why Organizations Are Moving to Self-Ser...Lean Business Intelligence - How and Why Organizations Are Moving to Self-Ser...
Lean Business Intelligence - How and Why Organizations Are Moving to Self-Ser...
 
Inventory Optimization: A Technique for Improving Operational-Inventory Targets
Inventory Optimization: A Technique for Improving Operational-Inventory TargetsInventory Optimization: A Technique for Improving Operational-Inventory Targets
Inventory Optimization: A Technique for Improving Operational-Inventory Targets
 
Improving Organizational Performance Through Pervasive Business Intelligence
Improving Organizational Performance Through Pervasive Business IntelligenceImproving Organizational Performance Through Pervasive Business Intelligence
Improving Organizational Performance Through Pervasive Business Intelligence
 
IDC Energy Insights - Enterprise Risk Management
IDC Energy Insights - Enterprise Risk ManagementIDC Energy Insights - Enterprise Risk Management
IDC Energy Insights - Enterprise Risk Management
 
High Efficiency in Manufacturing Operations
High Efficiency in Manufacturing OperationsHigh Efficiency in Manufacturing Operations
High Efficiency in Manufacturing Operations
 
Enterprise Knowledge Workers: Understanding Risks and Opportunities
Enterprise Knowledge Workers: Understanding Risks and OpportunitiesEnterprise Knowledge Workers: Understanding Risks and Opportunities
Enterprise Knowledge Workers: Understanding Risks and Opportunities
 
Enterprise Information Management: In Support of Operational, Analytic, and G...
Enterprise Information Management: In Support of Operational, Analytic, and G...Enterprise Information Management: In Support of Operational, Analytic, and G...
Enterprise Information Management: In Support of Operational, Analytic, and G...
 
Enabling Strategy and Innovation: Achieving Optimized Outcomes from Planning ...
Enabling Strategy and Innovation: Achieving Optimized Outcomes from Planning ...Enabling Strategy and Innovation: Achieving Optimized Outcomes from Planning ...
Enabling Strategy and Innovation: Achieving Optimized Outcomes from Planning ...
 
Data Quality Strategy: A Step-by-Step Approach
Data Quality Strategy: A Step-by-Step ApproachData Quality Strategy: A Step-by-Step Approach
Data Quality Strategy: A Step-by-Step Approach
 
Data Migration: A White Paper by Bloor Research
Data Migration: A White Paper by Bloor ResearchData Migration: A White Paper by Bloor Research
Data Migration: A White Paper by Bloor Research
 
Automating Stimulus Fund Reporting: How New Technologies Simplify Federal Rep...
Automating Stimulus Fund Reporting: How New Technologies Simplify Federal Rep...Automating Stimulus Fund Reporting: How New Technologies Simplify Federal Rep...
Automating Stimulus Fund Reporting: How New Technologies Simplify Federal Rep...
 

Recently uploaded

You Get Me! Leveraging Communication Styles in Virtual Trainingpptx
You Get Me! Leveraging Communication Styles in Virtual TrainingpptxYou Get Me! Leveraging Communication Styles in Virtual Trainingpptx
You Get Me! Leveraging Communication Styles in Virtual Trainingpptx
Cynthia Clay
 
Zodiac Signs and Fashion: Dressing to Suit Your Astrological Style
Zodiac Signs and Fashion: Dressing to Suit Your Astrological StyleZodiac Signs and Fashion: Dressing to Suit Your Astrological Style
Zodiac Signs and Fashion: Dressing to Suit Your Astrological Style
my Pandit
 
10 Barriers to Effective Communications.
10 Barriers to Effective Communications.10 Barriers to Effective Communications.
10 Barriers to Effective Communications.
Cora335316
 
HiFi Girls Call Surat 000XX00000 Provide Best And Top Girl Service And No1 in...
HiFi Girls Call Surat 000XX00000 Provide Best And Top Girl Service And No1 in...HiFi Girls Call Surat 000XX00000 Provide Best And Top Girl Service And No1 in...
HiFi Girls Call Surat 000XX00000 Provide Best And Top Girl Service And No1 in...
pranjalgarg474
 
Qatar Airways Kuwait Office.pdf.........
Qatar Airways Kuwait Office.pdf.........Qatar Airways Kuwait Office.pdf.........
Qatar Airways Kuwait Office.pdf.........
anissageorge9890
 
STEPIC Innovations 2026 futurism publications
STEPIC Innovations 2026 futurism publicationsSTEPIC Innovations 2026 futurism publications
STEPIC Innovations 2026 futurism publications
mcynthus
 
Millionaire track government application
Millionaire track government applicationMillionaire track government application
Millionaire track government application
pragyasharma659549
 
YouTube Automation Step-by-step Guide.pdf
YouTube Automation Step-by-step Guide.pdfYouTube Automation Step-by-step Guide.pdf
YouTube Automation Step-by-step Guide.pdf
grizzyhuncho
 
Cracking the Customer Experience Code.pptx
Cracking the Customer Experience Code.pptxCracking the Customer Experience Code.pptx
Cracking the Customer Experience Code.pptx
Workforce Group
 
Restaurant Chiraz Sindbad Hotel Hammamet
Restaurant Chiraz Sindbad Hotel HammametRestaurant Chiraz Sindbad Hotel Hammamet
Restaurant Chiraz Sindbad Hotel Hammamet
rihabkorbi24
 
Growth Buyouts - The Dawn of the GBO (Slow Ventures)
Growth Buyouts - The  Dawn of the GBO (Slow Ventures)Growth Buyouts - The  Dawn of the GBO (Slow Ventures)
Growth Buyouts - The Dawn of the GBO (Slow Ventures)
Razin Mustafiz
 
STRATEGY TO OVERCOME CURRENT PROBLEMS AT MTC.pptx
STRATEGY TO OVERCOME CURRENT PROBLEMS AT MTC.pptxSTRATEGY TO OVERCOME CURRENT PROBLEMS AT MTC.pptx
STRATEGY TO OVERCOME CURRENT PROBLEMS AT MTC.pptx
ImranTabish1
 
High Profile Girls Call Bhubaneswar 🎈🔥000XX00000 🔥💋🎈 Provide Best And Top Gir...
High Profile Girls Call Bhubaneswar 🎈🔥000XX00000 🔥💋🎈 Provide Best And Top Gir...High Profile Girls Call Bhubaneswar 🎈🔥000XX00000 🔥💋🎈 Provide Best And Top Gir...
High Profile Girls Call Bhubaneswar 🎈🔥000XX00000 🔥💋🎈 Provide Best And Top Gir...
dimplekumaridk322
 
Connected Small Boat Protection Solution | July 2024
Connected Small Boat Protection Solution | July  2024Connected Small Boat Protection Solution | July  2024
Connected Small Boat Protection Solution | July 2024
Hector Del Castillo, CPM, CPMM
 
TEST BANK For Auditing & Assurance Services A Systematic Approach, 12th Editi...
TEST BANK For Auditing & Assurance Services A Systematic Approach, 12th Editi...TEST BANK For Auditing & Assurance Services A Systematic Approach, 12th Editi...
TEST BANK For Auditing & Assurance Services A Systematic Approach, 12th Editi...
kevinkariuki227
 
Corporate Governance for South African Mining Companies
Corporate Governance for South African Mining CompaniesCorporate Governance for South African Mining Companies
Corporate Governance for South African Mining Companies
James AH Campbell
 
Top Digital Marketing Strategy in 2024.pdf
Top Digital Marketing Strategy in 2024.pdfTop Digital Marketing Strategy in 2024.pdf
Top Digital Marketing Strategy in 2024.pdf
Top IT Marketing
 
Girls Call Kharghar 9910780858 Provide Best And Top Girl Service And No1 in City
Girls Call Kharghar 9910780858 Provide Best And Top Girl Service And No1 in CityGirls Call Kharghar 9910780858 Provide Best And Top Girl Service And No1 in City
Girls Call Kharghar 9910780858 Provide Best And Top Girl Service And No1 in City
maigasapphire
 
New Girls Call Mumbai 9910780858 Provide Best And Top Girl Service And No1 in...
New Girls Call Mumbai 9910780858 Provide Best And Top Girl Service And No1 in...New Girls Call Mumbai 9910780858 Provide Best And Top Girl Service And No1 in...
New Girls Call Mumbai 9910780858 Provide Best And Top Girl Service And No1 in...
44annissa
 
How Do Flange Adapters Work and Why Are They Essential?
How Do Flange Adapters Work and Why Are They Essential?How Do Flange Adapters Work and Why Are They Essential?
How Do Flange Adapters Work and Why Are They Essential?
Texas Flange
 

Recently uploaded (20)

You Get Me! Leveraging Communication Styles in Virtual Trainingpptx
You Get Me! Leveraging Communication Styles in Virtual TrainingpptxYou Get Me! Leveraging Communication Styles in Virtual Trainingpptx
You Get Me! Leveraging Communication Styles in Virtual Trainingpptx
 
Zodiac Signs and Fashion: Dressing to Suit Your Astrological Style
Zodiac Signs and Fashion: Dressing to Suit Your Astrological StyleZodiac Signs and Fashion: Dressing to Suit Your Astrological Style
Zodiac Signs and Fashion: Dressing to Suit Your Astrological Style
 
10 Barriers to Effective Communications.
10 Barriers to Effective Communications.10 Barriers to Effective Communications.
10 Barriers to Effective Communications.
 
HiFi Girls Call Surat 000XX00000 Provide Best And Top Girl Service And No1 in...
HiFi Girls Call Surat 000XX00000 Provide Best And Top Girl Service And No1 in...HiFi Girls Call Surat 000XX00000 Provide Best And Top Girl Service And No1 in...
HiFi Girls Call Surat 000XX00000 Provide Best And Top Girl Service And No1 in...
 
Qatar Airways Kuwait Office.pdf.........
Qatar Airways Kuwait Office.pdf.........Qatar Airways Kuwait Office.pdf.........
Qatar Airways Kuwait Office.pdf.........
 
STEPIC Innovations 2026 futurism publications
STEPIC Innovations 2026 futurism publicationsSTEPIC Innovations 2026 futurism publications
STEPIC Innovations 2026 futurism publications
 
Millionaire track government application
Millionaire track government applicationMillionaire track government application
Millionaire track government application
 
YouTube Automation Step-by-step Guide.pdf
YouTube Automation Step-by-step Guide.pdfYouTube Automation Step-by-step Guide.pdf
YouTube Automation Step-by-step Guide.pdf
 
Cracking the Customer Experience Code.pptx
Cracking the Customer Experience Code.pptxCracking the Customer Experience Code.pptx
Cracking the Customer Experience Code.pptx
 
Restaurant Chiraz Sindbad Hotel Hammamet
Restaurant Chiraz Sindbad Hotel HammametRestaurant Chiraz Sindbad Hotel Hammamet
Restaurant Chiraz Sindbad Hotel Hammamet
 
Growth Buyouts - The Dawn of the GBO (Slow Ventures)
Growth Buyouts - The  Dawn of the GBO (Slow Ventures)Growth Buyouts - The  Dawn of the GBO (Slow Ventures)
Growth Buyouts - The Dawn of the GBO (Slow Ventures)
 
STRATEGY TO OVERCOME CURRENT PROBLEMS AT MTC.pptx
STRATEGY TO OVERCOME CURRENT PROBLEMS AT MTC.pptxSTRATEGY TO OVERCOME CURRENT PROBLEMS AT MTC.pptx
STRATEGY TO OVERCOME CURRENT PROBLEMS AT MTC.pptx
 
High Profile Girls Call Bhubaneswar 🎈🔥000XX00000 🔥💋🎈 Provide Best And Top Gir...
High Profile Girls Call Bhubaneswar 🎈🔥000XX00000 🔥💋🎈 Provide Best And Top Gir...High Profile Girls Call Bhubaneswar 🎈🔥000XX00000 🔥💋🎈 Provide Best And Top Gir...
High Profile Girls Call Bhubaneswar 🎈🔥000XX00000 🔥💋🎈 Provide Best And Top Gir...
 
Connected Small Boat Protection Solution | July 2024
Connected Small Boat Protection Solution | July  2024Connected Small Boat Protection Solution | July  2024
Connected Small Boat Protection Solution | July 2024
 
TEST BANK For Auditing & Assurance Services A Systematic Approach, 12th Editi...
TEST BANK For Auditing & Assurance Services A Systematic Approach, 12th Editi...TEST BANK For Auditing & Assurance Services A Systematic Approach, 12th Editi...
TEST BANK For Auditing & Assurance Services A Systematic Approach, 12th Editi...
 
Corporate Governance for South African Mining Companies
Corporate Governance for South African Mining CompaniesCorporate Governance for South African Mining Companies
Corporate Governance for South African Mining Companies
 
Top Digital Marketing Strategy in 2024.pdf
Top Digital Marketing Strategy in 2024.pdfTop Digital Marketing Strategy in 2024.pdf
Top Digital Marketing Strategy in 2024.pdf
 
Girls Call Kharghar 9910780858 Provide Best And Top Girl Service And No1 in City
Girls Call Kharghar 9910780858 Provide Best And Top Girl Service And No1 in CityGirls Call Kharghar 9910780858 Provide Best And Top Girl Service And No1 in City
Girls Call Kharghar 9910780858 Provide Best And Top Girl Service And No1 in City
 
New Girls Call Mumbai 9910780858 Provide Best And Top Girl Service And No1 in...
New Girls Call Mumbai 9910780858 Provide Best And Top Girl Service And No1 in...New Girls Call Mumbai 9910780858 Provide Best And Top Girl Service And No1 in...
New Girls Call Mumbai 9910780858 Provide Best And Top Girl Service And No1 in...
 
How Do Flange Adapters Work and Why Are They Essential?
How Do Flange Adapters Work and Why Are They Essential?How Do Flange Adapters Work and Why Are They Essential?
How Do Flange Adapters Work and Why Are They Essential?
 

Achieving Compliant Manufacturing Excellence through Real-time Performance Management

  • 1. ARC WHITEPAPER SEPTEMBER 2007 Achieving Compliant Manufacturing Excellence through Real-time Performance Management and Continuous Improvement Executive Summary .....................................................................3 Manufacturing Excellence in Regulated Industries ............................5 Today’s Compliance Challenges .....................................................6 Additional Challenges...................................................................8 Real-time Performance Management ........................................... 10 Synchronized Manufacturing Operations ....................................... 15 Realizing Manufacturing Excellence .............................................. 17 Summary ................................................................................. 19 THOUGHT LEADERS FOR MANUFACTURING & SUPPLY CHAIN
  • 2. ARC Whitepaper • September 2007 Greg Gorbach About the Author: Greg Gorbach: As ARC‟s Vice President, Collaborative Manufacturing and Architecture, Greg Gorbach is a thought leader in Collaborative Manufacturing and provides clients in a number of manufacturing vertical markets with strategic advice in dealing with boundary-crossing business processes. Greg’s primary areas of focus are Collaborative Manufacturing, Oper- ations Management, Business Process Management, Manufacturing Performance Services, and the synchronization of plant systems with CRM, ERP, PLM, Supply Chain and other business systems. He brings over twenty years of hands-on experience to ARC, with direct experience within manufacturing organizations, as well as extensive ex- perience with suppliers to manufacturers. This paper was commissioned by SAP. For additional information about SAP products and services, please contact SAP at: www.sap.com 2 • Copyright © ARC Advisory Group • ARCweb.com
  • 3. ARC Whitepaper • September 2007 Executive Summary Life Sciences manufacturers are feeling new pressure on their operations from many directions. Dynamic market needs, increased compliance re- quirements, more distributed manufacturing operations, rapid product innovation, Lean manufacturing, and the approaching transition to new IT technology all manifest themselves on the plant floor and throughout the en- terprise - and often lead to pleas for new technology solutions. Compliance management, integration, and data utilization are key issues to address in order to improve responsiveness and performance. Many manufacturing companies recognize that improving corporate perfor- mance demands better synchronization with the plant floor. At the same time, moving to a risk-based approach to compliance may require new sys- tems and improved data visibility. For too long, manufacturing has been isolated. Most of the important production data has not been easily accessible, and is therefore not very useful in improving performance. Today, however, feasible solutions are available to drive excellence in manufacturing performance through better manufacturing intel- ligence and integration. Real-time Performance Management (RPM) solutions acquire manufac- Fig 1: Value Network Dynamics Drive Manufacturing turing data in real-time, establish Performance Requirements; Better Integration and Data Utilization Enable Manufacturing Excellence and the operating context for that data, Optimal Real-time Performance and ensure that it is stored in a manner that makes it accessible at later times for a variety of uses. RPM facilitates the visibility of this real-time manufacturing data to users throughout the enterprise, and includes tools for enhanced decision support and role-based display of performance against operating metrics. Event-based triggers notify all who should be informed when important or unforeseen events take place. These solutions help com- panies achieve a higher level of manufacturing excellence by allowing them to better leverage their detailed manufacturing information. Copyright © ARC Advisory Group • ARCweb.com • 3
  • 4. ARC Whitepaper • September 2007 In many companies, it falls to IT to envision new business possibilities in concert with the technologies needed to realize them. At the same time, the usual job of reducing the cost of doing business through increased efficiency and productivity cannot be ignored. This paper outlines how modern solu- tions can support both strategies at the same time. Sample Business Challenges Strategies Healthcare marketplace changes increa- Drive efficiency to world-class levels; singly are constraining prices and hence for example, from 60% to 85% by bet- profitability ter utilizing manufacturing data Manufacturing to high quality standards; Achieve significant improvement in First need to reduce the “cost of quality” and Pass Yield and OEE by improving visi- improve productivity bility of quality data Increase competitive advantage by driv- Reduce operation costs through in- ing down production costs and COGS creased yield and efficiency; reduce material waste; avoid expensive peak outsourcing of manufacturing and dis- tribution by improving utilization of existing plant and facilities Regulations seek to establish that each of Document that Standard Operating Pro- “5 Ms” (Man, Machine, Materials, Method, cedures (SOPs) are followed by certified and Measure) has been used appro- operators on certified equipment, and priately during manufacturing. that approved manufacturing route, Bill of Materials (BOMs), recipes, and work instructions or manufacturing bills are used. Need to continuously improve margins Reduce operation costs through in- and cost structure in core businesses to creased yield and efficiency fund product development and growth in new markets Imperative to improve competitive posi- Reduce or eliminate non-value added tion through innovation. In order to get work to free up time for innovation by to the next level, need creative solutions providing data and analysis tools. Pro- and improvements to the manufacturing vide broad information visibility and process. analytics to spark innovative ideas. Our Balanced Scorecard methodology Provide real-time manufacturing per- needs information from sources outside formance information to corporate our ERP system performance systems. Our Six Sigma methodology has become Automate the Six Sigma Control Plans ingrained in our culture, but our Six Sig- and provide real-time, exception-based ma Control Plans have a limited value notifications to owners so they can take because they exist as a spreadsheet or immediate action. Word document and are difficult to ad- here to. To maintain and improve responsiveness Increase data utilization: move from and customer satisfaction, Plant opera- data collection, to performance visibility tions needs to be better integrated with and analytics, to closed-loop business business systems and the supply chain scenario deployment Table 1: Today’s Business Challenges Require Strategies Based on Better Utilization of Manufacturing Data. 4 • Copyright © ARC Advisory Group • ARCweb.com
  • 5. ARC Whitepaper • September 2007 Manufacturing Excellence in Regulated Industries Bio-pharmaceutical or medical device manufacturers can achieve compliance with FDA and EU/ISO regulations by focusing on specific processes that in- fluence product quality and safety. High-risk processes can be identified using a scientific risk-based assessment, an approach supported by regulato- ry agencies and industry. By focusing on manufacturing excellence, manufacturers can reduce the cost and time needed to achieve and maintain compliance. A manufacturing performance excellence focus yields better production management and recordkeeping, documented compliance with regulations, and profitability, flexibility, and quality [Table 1]. Compliant Manufacturers in the Life Sciences industry pursue excellence in manufacturing operations. Comparable to ARC‟s Collaborative Manufacturing Management, SAP‟s Compliant Manufacturing is a vision for how companies participate in an ecosystem or business network, are able to leverage the network‟s cumulative ability to plan and anticipate demand and supply, ex- ecute plans efficiently and effectively, comply with appropriate regulations, sense meaningful events in real-time, and respond to and learn from ever- changing business conditions. Manufacturing Excellence is a critical aspect of compliant manufacturing op- erations for regulated industries. Excellent performance is characterized by the ability to react quickly to changing marketplace conditions, to dynamical- ly reflect these changes in production targets, and to efficiently and reliably achieve these targets. It also requires ongoing cost reductions and quality improvement. In order to achieve manufacturing excellence, manufacturers need to manage based on real-time performance information. Grounded in operations, Real- time Performance Management (RPM) encompasses the processes, metho- dologies, metrics, systems, and information needed to measure and manage the performance of a manufacturing organization. RPM places particular emphasis on: acquiring and using real-time, plant level, performance and operating data; providing actionable intelligence based on analytics, event triggers, and visibility; KPI support; and, integration to business systems. RPM provides the real-time plant level information needed by the planning and financial reporting/analysis functions of Corporate Performance Man- agement systems. Copyright © ARC Advisory Group • ARCweb.com • 5
  • 6. ARC Whitepaper • September 2007 Today’s Compliance Challenges With expanding regulatory initiatives [Table 2] and tighter enforcement poli- cies, bio-pharmaceutical and medical device manufacturers need to have a better view of manufacturing data as well as business processes that span departments and applications. They need to en- Regulated Applicable force manufacturing best practices, while ensuring Process Areas Regulations and documenting regulatory compliance. Specific Equipment and FDA 21 CFR Part 820.75, regulated process areas and associated functional Facilities Part 211 subpart C and D requirements for compliance are outlined here. Production and FDA 21 CFR Part Process Control 820.70/72/75 Part 211 subpart F and I Equipment and Facilities EU/ISO 13485: 6.3, 7.5, Life Sciences manufacturing requires a suitable en- 7.6, 8.2.3 vironment and specific equipment that is properly Materials FDA 21 CFR Part 820. Incoming 50/80/86 maintained and calibrated. Specified and actual Inspection Part 211 subpart E manufacturing information must be monitored and EU/ISO 13485: 7.4.1, 7.2.2, 7.4.3, 7.5.3.2 recorded. Compliance solutions should qualify equipment suitability, verify environment status, Product Design FDA 21 CFR Part 820.30 and Definition verify status of equipment and resources at time of manufacture, support dynamic process routing, and Validation FDA Guidance, Part 11 assure proper maintenance and calibration. Revision Control FDA 21 CFR Part 820.40 EU/ISO 13485:4.2.3 Production and Process Control Identity Control 21 CFR Part 11, EU cGMPs Consider the "Five M's" for controlling manufactur- Quality and SPC FDA 21 CFR Part 820.250, Part 211 subpart F ing processes: Man, Machine, Materials, Method, EU/ISO 13485: 8.1, 8.2.3, and Measure. Regulations in this area seek to estab- 8.2.4, 8.4 lish that each has been used appropriately during CAPA FDA 21 CFR Parts 820.100 manufacturing. Manufacturers must ensure that Part 211 subpart F EU/ISO 13485: 8.5.2, 8.5.3 Standard Operating Procedures (SOPs) are fol- lowed by certified operators on certified equipment. Traceability FDA 21 CFR Parts 820.60/65 It is important to document manufacturing routes, Part 211 subpart J approved Bill of Materials (BOMs), recipes, and EU/ISO 13485: 7.5.3, 7.5.5 work instructions or manufacturing bills. Some Device, Batch FDA 21 CFR Part 820.184 manufacturing in the life sciences industries re- History Record Part 211 subpart J EU/ISO 13485: 4.2.4 quires solutions that integrate Statistical Process RMA and Com- FDA 21 CFR Parts 820.200 Control (SPC) with production. plaint Tracking EU/ISO 13485: 7.5.1.2.3, 7.5.1.3 Materials Incoming Inspection Table 2: Major Regulated Processes in Life Sciences Manufacturing The quality of the finished product depends on the 6 • Copyright © ARC Advisory Group • ARCweb.com
  • 7. ARC Whitepaper • September 2007 quality of the materials used. This means tracking supplier quality ratings, incoming quality assays and audits, material review, and integrated supplier Corrective and Preventative Action solutions. Solutions should manage and document raw material inventory, track raw material receipts, provide for receiving and final acceptance, and link to LIMS systems. Product Design and Definition In the medical device industry, it is critical to ensure that manufacturing stays in synch with product design changes, and that traceability extends to design documentation. Manufacturers must document implementation of Engineering Change Orders (ECO) and ensure that manufacturing process documentation changes are made as of the effective date. Solutions should provide revision controlled routings and BOMs, and generate Device Manu- facturing Records and Device History Files. Process Validation and Revision Control In the bio-pharmaceutical industry, manufacturing systems and their sub- systems must be validated with adequate change control. This requires Iden- tity Assurance Management for access and authorization. Timely notification of unauthorized attempts to access is also required. When changes are made, the proper approvals are secured and changes are tracked. This requires electronic signatures for revisions, adequate change control capability, and the ability to ensure that proper versions of work instructions, recipes, and SOPs are presented to the operator in production. Identity Control Assuring the identity of the person taking an action is critical to meeting reg- ulatory requirements. The FDA states that there must be an environment that ensures the "non-refutability" of a person's signature. Identity Assur- ance Management should provide uniform procedures, a common presentation across the platform, and a multiple application specific technol- ogy capability. Quality and SPC Collecting, analyzing, and acting upon quality data is critical in any com- pliance situation. Critical to manufacturing excellence are parametric data collection and quality analysis tools to show yields, defects, and the like. SPC capabilities should allow for custom SPC rules with rule violation trig- gers to generate alerts or actions such as material holds. Copyright © ARC Advisory Group • ARCweb.com • 7
  • 8. ARC Whitepaper • September 2007 CAPA Corrective And Preventive Action (CAPA) solutions must touch all aspects of manufacturing, and extend to external complaints as well as incoming ma- terials and suppliers. These systems should track and resolve non- conformances, track failed acceptance criteria, provide flexible tools for the design and execution of CAPA workflows, leverage SPC functionality for root cause analysis, and facilitate the implementation of corrective actions. Forward and Backward Traceability Manufacturers must be able to track units, lots and batches from end to end, no matter how complicated or simple the manufacturing process. This requires unit, lot, and batch tracking and date code capabilities. Tracking lots through „splits‟ and „combines‟ is also required. Device or Batch History Record Preparing for audits or required reporting is facilitated with an electronic Device or Batch History Record. This requires as-designed, as- manufactured, and as-maintained traceability, with an easily retrievable and viewable Device or Batch History Record, including links to other required records associated with the Device or Batch History Record. RMA, Complaint Tracking, and Adverse Event Reporting Post-production services such as complaint tracking, Return Materials Au- thorization, and field service must link back to manufacturing in order to correct and improve the manufacturing process. RMA tracking, complaint or adverse event tracking, as-maintained information capture, and integration to CAPA systems should be provided. Additional Challenges Life Sciences manufacturers are directly feeling new pressure on their opera- tions and it comes from many directions simultaneously. Dynamic market requirements, increased compliance needs, more distributed manufacturing operations, rapid product innovation, Lean manufacturing, and the ap- proaching transition to new IT technology all manifest themselves on the plant floor. Too often, the symptoms go unrecognized. For example, it may be that supervisors are in a constant state of firefighting, or spending more and more time expediting. This can be related to shorter delivery promise 8 • Copyright © ARC Advisory Group • ARCweb.com
  • 9. ARC Whitepaper • September 2007 windows, faster turnaround, and more customer status inquiries. The situa- tion is exacerbated when plant personnel are not immediately informed about manufacturing exceptions, because small perturbations have a much larger impact when the system is running under pressure [Table 3]. In other cases, operators may be missing their performance targets and are unable to meet continuous process improvement goals. Business and plant Production Data Issues Remedies Key data is in Excel spreadsheets, clip- Collect key data electronically and make boards, applications, production it widely available throughout the or- lines/equipment, and databases ganization Plant production data needed by ERP is Automatically collect and transfer plant manually collected, often re-entered, and data needed by ERP manually transferred from spreadsheet to spreadsheet as it moves from plant data sources to the ERP system It is very difficult to get information that Collect and contextualize data from all is in different departments. Different departments electronically in real-time systems/applications, conventions, busi- and make it widely available throughout ness cycles, and the like complicate the the organization collection and rationalization of data It is difficult, time-consuming, and costly Speed analysis and minimize cost by to interpret the data and prepare leveraging solutions that provide graph- graphs/charts/reports that help identify ical display, drilldown, and analytical problems and root causes tools. Shop floor technicians enter some data Provide a simplified “front” screen for via three, four, or five ERP screens. This ERP data entry. is too time-consuming and is prone to errors. We’ve gotten good at collecting lots of Provide a unified, consistent view of data – but our needs have matured and data; visualization and analysis tools, we need to integrate that data with other and robust integration. areas. Our schedule is on a big whiteboard Electronic schedule with extensive visi- bility, linked to real-time performance data. We have to respond to customer Quality Dramatically reduce the burden of re- Notifications, even though the issues search to answer customer quality and may not end up being traceable to our production inquiries. Collect and con- products (because a number of materials textualize data from all departments come into play simultaneously down- electronically in real-time and make it stream in our customer’s manufacturing widely available throughout the organi- processes). It can take 5-7 days to pull zation. Speed analysis and minimize together the data needed to satisfy the cost by leveraging solutions that pro- customer vide graphical display, drilldown, and analytical tools. Table 3: A Sampling of Typical Issues Manufacturers Encounter When Production Data is Underutilized Copyright © ARC Advisory Group • ARCweb.com • 9
  • 10. ARC Whitepaper • September 2007 managers may be missing their budgets more frequently. Perhaps variations in manufacturing performance across shifts, lines and plants are inexplicably widening. These may all be signs that things are beginning to slip because people are no longer able to effectively monitor, measure, analyze, control and improve key performance indicators (KPIs) against targets as the pace increases. Managers cannot get the information they need to measure and control actual production costs against targets, and supervisors waste time accessing and searching through multiple systems for needed data. In mid-size and larger manufacturing enterprises, the problems are com- pounded by the need to assess and improve performance across multiple, possibly globally distributed, facilities and business units. Without accurate and timely asset-to-asset and plant-to-plant comparison data, this is difficult and impractical. To address these challenges, manufacturers need solutions that allow them to see and use real-time information from operations. They need solutions that facilitate excellent manufacturing performance and enterprise-wide process synchronization. Real-time Performance Management Real-time Performance Management (RPM) is a term that describes all of the processes, metrics, techniques, and systems needed to measure and manage the performance of a manufacturing organization. RPM is primarily focused at the plant level but has significant touch- points within the business systems. It complements and extends Corporate Performance Management systems [Figure 2] [Table 4]. RPM solutions acquire manufacturing data in real-time, estab- lish the operating context for that data, and ensure that it is stored in a manner that makes it accessible at later times for a variety of uses. RPM facilitates the visibility of real-time man- ufacturing data to users throughout the enterprise, and includes tools for enhanced decision support and role-based display of performance against operating metrics. Event-based Fig 2: RPM Enables Adaptive Manufacturing triggers are also provided to notify all who should be informed when important or unforeseen events take place. These solu- 10 • Copyright © ARC Advisory Group • ARCweb.com
  • 11. ARC Whitepaper • September 2007 tions help companies achieve a higher level of manufacturing excellence by allowing them to better leverage their detailed manufacturing information. Another important role for RPM solutions is to synchronize the plant floor with increasingly dynamic business operations. This includes providing en- terprise-wide visibility of manufacturing data, including certain operating data, compliance information originating in the plant, and capacity and cost data. Information needs to flow in both directions, to support work planning and deployment as well as plant floor visibility of selected financial informa- tion for plant floor metrics. As the need to use manufacturing data matures, business processes become more automated, and closed loop scenarios begin to operate between business systems and plant systems. RPM solutions pro- Function CPM RPM Notes (Definition) Corporate Real-time CPM is an umbrella term that describes all of the Performance Performance processes, techniques, metrics, and systems Management Management needed to measure and manage the performance of an organization. RPM extends this to real-time manufacturing information. Planning Strategic Provide Real-time Strategic planning, sales planning, expense plan- Planning, Sales Mfg data for ning, and risk analysis. Establish data, process, and Planning, etc. Corporate Plan- policy requirements. Budgeting, modeling, plan- ning Activities ning, forecasting. Financial General Ledger, Financial compo- Multi-jurisdiction, reports, financial feed to metrics; Reporting & A/R, A/P, & nent of plant provide compliance info to financial sys- Analysis other financial metrics; tems/executives. analyses; Compliance info Consolidation from plant Intelligence/ BI/Decision MI/Decision Performance indicators, reporting, analysis, dash- Decision Support Support boards, queries, alerts, notification, event/activity Support management Metrics/ Corporate Production KPIs, Metrics mgt, Planning-based metrics, Reporting, Scorecarding Metrics Real-time OpX etc. Establish targets, link metrics to underlying Management Data data, maintain and show relationships among me- trics; drive Continuous Improvement initiatives Real-time n/a Real-time Manufacturing data acquisition, contextualization, Manufacturing Manufacturing processing, storage Information Information Business n/a Business Closed loop business process integration; enter- Integration Integration prise-wide visibility of mfg data; Plant visibility of selected financial info for metrics Table 4: RPM Complements and Extends Corporate Performance Management vide the real-time manufacturing data, information, analysis, and synchronization needed to operate at a high level of manufacturing excel- Copyright © ARC Advisory Group • ARCweb.com • 11
  • 12. ARC Whitepaper • September 2007 lence, while supporting the corporation in excellent overall business mance. It is important to distinguish real-time solutions from solutions that provide information on a daily or weekly basis. Real-time solutions make informa- tion “actionable” at the point in time when it has the greatest potential impact. This can mean the difference between one or two items and a whole day‟s worth of out-of spec product taking up space, waiting for disposition as scrap or rework while the customer awaits delivery of their orders. Real- time solutions create ROI by exposing business opportunities that might oth- erwise be lost. In today‟s competitive environment, “Manufacturing Excellence” represents far more than just making the machines and personnel in the plant effective. Compliant Manufacturers respond proactively to unforeseen events, excep- tions, and increasingly rapid changes in demand and supply. The manner in which that manufacturer utilizes plant floor data determines their ability to do this effectively. Historically, some data is gathered manually and other data accumulates in isolated plant systems. Data gathered in this manner may serve as a historical record, but is essentially unavailable for use in daily operations or for continuous improvement programs. Fig 3: Manufacturing Excellence Depends Upon the Robust Use of Manufacturing Data 12 • Copyright © ARC Advisory Group • ARCweb.com
  • 13. ARC Whitepaper • September 2007 Many manufacturers are beginning to use systems to collect and contextual- ize plant data and make it visible to a variety of users. The availability of real-time information aids in operational decision-making and the organiza- tion reaps benefits in the form of efficiency and yield improvements, OEE, and the like. Analytical tools extend the ability to make better decisions. Adding event-triggered alerts reduces the reaction time for changes, failures, opportunities, and problems, and can significantly improve overall perfor- mance. Responses to certain alerts can be preordained and enforced by workflow solutions, further enhancing performance. Organizations can reap even greater gains when workflow or business process management tools are used to synchronize business processes across departments and operations and between business and plant floor systems. Solutions for this level of synchronization can also typically support multiple plants with a normalized view of performance across disparate systems. At the highest level, organizations can leverage the plant data/information to support the use of tools for modeling new business processes and the change management process for implementing them. Fig 4: Improve Manufacturing Excellence by Using Data Effectively and Extending RPM to the Enterprise and Across the Supply Network Copyright © ARC Advisory Group • ARCweb.com • 13
  • 14. ARC Whitepaper • September 2007 Greater Than the Sum of the Parts As RPM is rolled out beyond the original pilot implementation, higher levels of benefits are obtained. Since RPM “snaps on” to existing systems, instead of replacing or replicating them, an extended deployment can proceed at a rapid pace. In addition, RPM is an approach that supports all categories of metrics such as Assets, Quality, Manufacturing, and Cost, and therefore a single solution can deliver performance benefits in all of these areas. When a significant portion of one plant‟s operations are involved [Figure 4], that plant sees better performance as well as better service to its customers. As RPM is extended to multiple plants and the bulk of the enterprise, business managers at all levels are empowered to make better decisions based on a unified view of the distributed real-time manufacturing data. This can lead to a quantum change in performance for any manufacturing enterprise. Each plant has the information necessary to optimize its efforts in support of en- terprise priorities. Regional and corporate managers have accurate information feeding their planning, allocation, risk management, and report- ing systems. The enterprise as a whole becomes much more adap- tive, and able to compete in previously unreachable areas. Real-time Manufacturing Data and Continuous Improvement A common use of RPM is to pro- vide data for the Measure phase of Six Sigma DMAIC processes. This can be implemented as data that appears in a quality dash- Fig 5: SAP xMII Synchronizes Manufacturing Operations with board. Leading manufacturers the Enterprise, in Heterogeneous Plant Floor IT Landscapes take this a step further. Instead of trying to manage the Control phase with plans drawn up in Microsoft Word or Excel documents, they use RPM to automate the control plans and notify process owners in real time about events or exceptions so that they can im- mediately take action. This approach can have a huge impact in the effectiveness of existing Six Sigma programs. Linking performance against metrics with Continuous Improvement speeds the improvement cycle, which creates more awareness of the value of RPM at other locations, as well as a functional baseline so new installations can be deployed more quickly. 14 • Copyright © ARC Advisory Group • ARCweb.com
  • 15. ARC Whitepaper • September 2007 SAP xMII SAP xMII connects to a wide variety of plant systems and data sources, such as MES, DCS, HMI, Plant Historians, Laboratory systems, Maintenance sys- tems, and other data sources [Figure 5]. It establishes the production context for data from these systems and makes the information visible to users and available to other applications. It also provides Category Description analytical tools to aid in decision-making and Data Bi-directional data access integration services to facilitate connectivity to Services Metadata browsing business systems. Manufacturing Integration XML-based data abstraction Connectors to external sys- tems SAP xMII collects and contextualizes plant data and make it visible to a variety of users. It sup- Business Logic Logic Integration services ports optimal decision making by providing Services Notification services “unified” real-time information and analytical Calculation and data transformation, tools. Event-triggered alerts speed reactions, Content creation problem identification, and problem resolution. Visualization Charts, Grids, tickers, UI con- It provides workflow-based responses, which Manufacturing Intelligence Services trols, can be configured for certain alerts. SAP xMII‟s Dashboard components integration capability includes synchronizing Analytic Ser- SPC/SQC (Six Sigma) analyses business processes across departments and oper- vices Statistical and other mathematical analyses ations and between business and plant floor Web All services exposed as web systems. It scales to support multiple plants with Services services a normalized view of performance across dispa- Includes user-defined rate systems. SAP xMII plant data/information composite services is readily available to inform tools for modeling Table 5: SAP xMII Core Functionality: Manufacturing Integration and Intelligence new business processes and the change man- agement process for implementing them. Synchronized Manufacturing Operations SAP xMII enables Compliant Manufacturing to drive manufacturing excel- lence by synchronizing manufacturing operations with business systems to deliver “one version of the truth”. Without such a solution in place, bad de- cisions can be made due to out of date or wrong data, or because different plants or departments have different methods and algorithms for populating the data. At best, it wastes time to sort this all out, and delayed decisions lead to lost profits and lost opportunities. “One version of the truth” is not intended to imply that there must be a single data repository for all data. It Copyright © ARC Advisory Group • ARCweb.com • 15
  • 16. ARC Whitepaper • September 2007 refers to the unification of information, so that users in various roles have personalized views of different aspects of the same information at the same time. This unified view of manufacturing information is provided by the combination of Manufacturing Intelligence – a real-time analytics engine that aggregates and delivers unified visualization of events, alerts, KPIs, and decision support to production personnel and appropriate other parties through role-based Enterprise Portal dashboards - and Manufacturing Inte- gration – a single, standards-compliant application enabling bi-directional SAP ERP connectivity into real-time plant floor applications to drive efficien- cy in enterprise business processes, whether in a single plant or across multiple plants, business units, and regions. Early adopters have identified performance improvements primarily in the areas of yield, production output and Labor. Adverse events trigger quick responses, so the line runs better and with more uptime. More product is created faster (production) while less material is needed for a given output (yield). Labor savings come from three primary sources: Less labor is needed to clear out and dispose of bad product; a more efficient line can lead to reductions in contingent labor, such as extra workers who can jump in to fix problems, crank out additional work or support additional shifts; and, in many cases, a significant reduction in labor occurs as the need to manually collect, analyze, and chart data is eliminated. How One Pharmaceutical Manufacturer Improved Performance and Reduced Cost with SAP xMII A large Pharmaceutical manufacturer, who is known for innovative products and services, and as a leading supplier of medicines in its key markets, em- ploys approximately 70,000 people in 150 countries. Having identified some fairly typical performance issues, this European-based company decided to introduce SAP xMII for data collection from a variety of sources, visibility at operator‟s workstations, and enhanced data transfer between systems. Prior to the implementation, the production staff could not easily identify issues and root causes, so reaction times were slow. Too much time and labor was used in manually copying and transferring data among multiple databases. Too often, wrong entries were made in validation or quality-critical processes. All of these issues were eliminated or improved with the imple- mentation of SAP xMII. The initial goals for the SAP xMII project were threefold. They sought to provide time-optimized, structured visualization of production data from 16 • Copyright © ARC Advisory Group • ARCweb.com
  • 17. ARC Whitepaper • September 2007 various systems. The second goal was integration between plant and enter- prise applications. And they wanted to improve performance by automating and enforcing pre-defined workflows and transactions in response to speci- fied production events. SAP xMII enabled the company to continuously display the duration of process phases executed on certain equipment for batch production, allowing monitoring and analysis. Using the dashboard, users could now access process data from an OSI PI Historian system. Batch and plant data were displayed for a certain time slice, with all information presented in struc- tured form. Process events were used to control the display and calculation of minimum, maximum, and phase times, together with standard deviations. Two plant-to-business integration scenarios were implemented. The first involved the SAP ERP (PP PI Module), an Oracle database, an OSI PI Histo- rian, and a SCADA operator panel. SAP process orders were combined with product-and phase-related setpoints, stored in a SQL database, and dis- played for plant operators. The second integration scenario was to calculate material consumption in batch production, and transfer the value to the SAP ERP system. In this case, the SAP ERP MM module, an OSI PI Historian, and an Oracle database were involved. SAP xMII monitored batch completion and obtained material consumption, plant and phase information, and PI tag names from the Oracle database. It computed start and end times for each material consumption, and transferred consumption values, material num- ber, batch ID, and consumption time to SAP ERP. This Pharmaceutical manufacturer realized significant process improvements by Performance Monitoring and Plant-to-Business integration with SAP xMII. They improved performance by enforcing planned reactions to events. They reduced the manual effort involved in data collection and transfer among databases. And they reduced cost associated with inaccurate data entry. Based on this project, multiple additional SAP xMII were justified. Realizing Manufacturing Excellence Performance is the measure of manufacturing excellence, but how should performance be measured? Unfortunately, no single measure is appropriate for every manufacturing enterprise. Small scale deployments may focus on OEE or cycle time, while enterprise-wide deployments require a complex set Copyright © ARC Advisory Group • ARCweb.com • 17
  • 18. ARC Whitepaper • September 2007 of coordinated metrics throughout various levels and regions. Metrics may be crafted around profitability, asset utilization, quality, headcount, customer satisfaction, and the like, but in the end, the performance measures currently relied upon by your company and your industry are likely to be the best me- trics to use to begin leveraging your manufacturing data in new ways to achieve manufacturing excellence. Improving the performance of the IT group can sometimes improve the per- formance of the entire enterprise. With real-time data, it becomes easy to prepare and distribute reports that were infeasible before. Armed with this information, managers, supervisors, and operators make better decisions and business performance improves. In many companies, the IT group has be- come increasingly burdened by supporting homegrown and legacy plant systems. An RPM solution can replace some of these applications, but a more powerful strategy is “front-ending” legacy applications. With this ap- proach, RPM user interfaces mimic those of legacy applications so the introduction of RPM has little or no impact on the operators. Once it is in place, rationalization of the underlying systems can proceed at any desired pace without further impact. This in itself can justify many projects, based on improving IT productivity by reducing legacy applications support costs. To be sure, plant operations can benefit directly - in terms of reductions in variable labor and overall production cost, together with increases in yield and production output. In addition, more productive use of capital equip- ment can enable manufacturers to avoid adding additional capital equipment in order to get more output. It can also reduce the need to contract out man- ufacturing during demand peaks. Early adopters have reported dramatic changes in the effectiveness of their morning meetings, which set the tone for the rest of the day. Instead of working from static, dated reports, manufacturing teams begin using the live RPM system at the daily meeting. Performance problems are spotted and addressed immediately, using the system to drill down to individual events and equipment to understand root causes. In some cases, Six Sigma or TPM leaders are given action items to conduct further analysis –again leveraging data from the live system. 18 • Copyright © ARC Advisory Group • ARCweb.com
  • 19. ARC Whitepaper • September 2007 Summary Manufacturers recognize that they need IT solutions designed to improve performance in order to respond to dynamic market pressures, to become more flexible, adaptive, and compliant to enhance competitive positioning. Real-time Performance Management (RPM) solutions acquire manufacturing data in real-time and synchronize the plant floor with increasingly dynamic business operations. These solutions drive excellence in manufacturing per- formance through better manufacturing intelligence and integration. They provide enterprise-wide visibility of manufacturing data, including key op- erating data, compliance information originating in the plant, and capacity and cost data. These systems are relatively light touch and minimal risk, be- cause they leverage existing systems and do not require expensive rip-and- replace or replicate strategies. They are also Category Strategic Benefit relatively quick to deploy, so value is rapidly generated. Despite this, they can have a po- Corporate Real-time manufacturing data Performance enhances corporate decision- werful impact in two ways: by contributing to making and aligns the plant floor reductions in the cost of doing business and with corporate initiatives increased productivity and efficiency, and by Competitive Increase competitive advantage Advantage by driving down production costs enabling new business processes or opportun- and increasing flexibility and res- ities. ponsiveness Continuous Accelerate continuous improve- Because RPM is an approach that spans all Improvement ment programs through increased categories of metrics such as Assets, Quality, data velocity and process auto- mation Manufacturing, and Cost, a single solution can deliver performance benefits in all of Quality Reduce the Cost of Quality with real-time operating data to im- these areas. When the measurement data for prove margins and fund product these metrics is linked to a continuous im- innovation provement program such as Six Sigma, the Capital Avoid capital expenditure and improvement cycle is accelerated and entire Expense peak outsourcing through better utilization of existing assets operations can rapidly move to higher levels Compliant Real-time information and process of performance. Manufacturing automation enable increased flex- ibility and responsiveness to It is important to distinguish real-time solu- ecosystem changes tions from solutions that provide information Table 6: RPM Contributes to Strategic on a daily or weekly basis. Real-time solu- Enterprise Performance tions make information “actionable” at the point in time when it has the greatest potential impact. It can mean the dif- ference between one or two items and a whole day‟s worth of out-of spec product taking up space, waiting for disposition as scrap or rework while the Copyright © ARC Advisory Group • ARCweb.com • 19
  • 20. ARC Whitepaper • September 2007 customer goes waiting. Real-time solutions create ROI by exposing business opportunities that might otherwise be lost. SAP xMII enables Compliant Manufacturing for Life Sciences by synchroniz- ing manufacturing operations with business systems to deliver “one version of the truth” and driving manufacturing excellence. This unified view of manufacturing information is provided by the combination of Manufactur- ing Intelligence – a real-time analytics engine that aggregates and delivers unified visualization of events, alerts, KPIs, and decision support to production personnel and appropriate other parties through role-based Enterprise Portal dashboards - and Manufacturing Integration – a single, standards-compliant application enabling bi-directional SAP ERP connectivity with real-time plant floor applications to drive efficiency in enterprise business processes, wheth- er in a single plant or across multiple plants, business units, and regions. SAP xMII connects to a wide variety of plant systems and data sources, such as MES, DCS, HMI, Plant Historians, Laboratory systems, Maintenance sys- tems, and other data sources. It establishes the production context for data from these systems and makes the information visible to users and available to other applications. It also provides analytical tools to aid in decision- making and integration services to facilitate connectivity to business systems. SAP xMII collects and contextualizes plant data and make it visible to a va- riety of users. It supports optimal decision making by providing “unified” real-time information and analytical tools. Event-triggered alerts speed reac- tions, problem identification, and problem resolution. It provides workflow- based responses, which can be configured for certain alerts. SAP xMII‟s inte- gration capability includes synchronizing business processes across departments and operations and between business and plant floor systems. It scales to support multiple plants [Figure 6] with a normalized view of per- formance across disparate systems. SAP xMII plant data/information is readily available to inform tools for modeling new business processes and the change management process for implementing them. For too long, manufacturing has been isolated and most important produc- tion data has not been easily accessible. As manufacturing companies begin their push to improve responsiveness and performance, they will find what leading companies already know: Real-time Performance Management (RPM) solutions drive excellence in manufacturing performance through better manufacturing intelligence and integration. 20 • Copyright © ARC Advisory Group • ARCweb.com
  • 21. ARC Whitepaper • September 2007 Fig 6: SAP xMII in a Multi-Plant Context Founded in 1986, ARC Advisory Group has grown to become the Thought Leader in Manufacturing and Supply Chain solutions. For even your most complex business issues, our analysts have the expert industry knowledge and firsthand experience to help you find the best answer. We focus on simple, yet critical goals: improving your return on assets, operational performance, total cost of ownership, project time-to-benefit, and shareholder value. All information in this report is proprietary to and copyrighted by ARC. No part of it may be reproduced without prior permission from ARC. You can take advantage of ARC's extensive ongoing research plus experience of our staff members through our Advisory Services. ARC’s Advisory Services are specifically designed for executives responsible for developing strategies and directions for their organizations. For subscription information, please call, fax, or write to: ARC Advisory Group, Three Allied Drive, Dedham, MA 02026 USA Tel: 781-471-1000, Fax: 781-471-1100, Email: info@ARCweb.com Visit our web page at ARCweb.com Copyright © ARC Advisory Group • ARCweb.com • 21
  • 22. 3 ALLIED DRIVE DEDHAM MA 02026 USA 781-471-1000 BOSTON, MA | WASHINGTON, D.C. | PITTSBURGH, PA | PHOENIX, AZ | SAN FRANCISCO, CA CAMBRIDGE, U.K. | DÜSSELDORF, GERMANY | MUNICH, GERMANY | HAMBURG, GERMANY | TOKYO, JAPAN | BANGALORE, INDIA | SHANGHAI, CHINA