Innoprod: The online tool for productivity. Benchmarking in plastic processing industry

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1 Innoprod: The online tool for productivity Benchmarking in plastic processing industry Farah Fawaz August 2013

2 Summary Companies need continuous improvement in productivity and cost reduction to cope with the increasing competition. Positioning them in order to allow comparison enhances productivity optimization. For the plastic injection industry this process is partly implemented by the Innoprod project, which became a real product! Innoprod is an online tool created to benchmark the productivity of firms counting at least one of their activities in plastic injection. Innoprod is available online and in three languages (French, German and Italian) and has been promoted in Switzerland as well as in Europe through the ALPlastics project. The research is based on the OPEX (Operational Excellence) model that focuses on four indicators: Total Productive Maintenance, Total Quality Management, Just-in-Time and Effective Management System. The benchmark is done on these four levels. This comparison is done using a survey of 155 questions. The OPEX model allows the companies to identify their weaknesses, so that they can take corrective actions in order to increase their level of Operational Excellence. The four indicators are the main points where companies should focus to improve their productivity. This analysis allows companies to better understand their structure and to position themselves in front of their competitors. The idea is to give to the production manager a productivity measurement tool that will on one hand improve the productivity and on the other hand reduce costs through the sharing of expertise and best practices. The company that has a login can fill the tool and it can generate automatically the benchmarking report. After the promotion of the project and explaining its use in January 2013 in Munich to the partners of the ALPlastics project, a workshop was organized in March 2013 in Fribourg to explain and analyze the benchmarking reports. Innoprod is now ready to be used, and the more companies participate the more the benchmarking results are decisive in the choice of corrective and improvement actions. 2

3 Table of content 1. Introduction Objectives The Innoprod Project The Innoprod Product Dissemination in the Alpine Space trough ALPlastics Methodology: Model OPEX (Operational Excellence) The four indicators (Enabler / Performance) Total Productive Maintenance Total Quality Management Just-In-Time Effective Management Systems The Questionnaire Overview of the seven question pools of the questionnaires Question pool: A. Your company Question pool: B. Cost structure and workforces of the site in {year} Question pool: C. Total Productive Maintenance System Enabler Question pool: D. Total Quality Management System Enabler Question pool: E. Just in Time System Enabler Question pool: F. Management System Enabler Question pool: G. Performance of the company Report and interpretation of results Calculations for the benchmark Report Examples Conclusion Reference Annex I. Calculation for Benchmark in French II. Report example II.1. French II.2. German II.3. Italian III. User's document III.1. Documentation: Gestion de l interface utilisateur III.2. Dokumentation: Verwaltung des Benutzer-Interface III.3. Documentazione: Gestione dell interfaccia utente IV. Administrator s document IV.1. Documentation: Gestion de l interface administrateur V. IT s document V.1. Documentation technique V.2. Source code

4 1. Introduction Companies need continuous improvement in productivity and cost reduction to cope with the increasing competition. Positioning them in order to allow a comparison, enhance productivity optimization. For the plastic injection industry this process is partly implemented by the project Innoprod, which became a real product! Innoprod is an online tool for the benchmark of the productivity of firms with at least one of their activity in plastic injection. This tool is available in three languages: French, German and Italian. The tool is available under the following link: With this tool the company can generate automatically a benchmarking report after successfully completing the whole questionnaire Objectives Companies in the same sector do not always share their expertise and do not offer a code of best practice even if they are related partners. It is therefore very difficult for companies to benchmark towards their competitors. The aim of this tool is to enable this benchmarking process by establishing a comparison between the productivity of different companies active in the field of plastic injection. These partner companies belong to the same macroeconomic environment, even if they occupy different markets. As previously mentioned, the objective of this benchmark is to improve the positioning of these companies in front of their competitors, by looking at their productivity. Innoprod will therefore make a first inventory of the productivity of plastic injection inside the company to identify strengths and weaknesses. The purpose was to create a tool for production managers to better measure their companies productivity and therefore to develop additional improvement measures. Innoprod will enable the members of Réseau plasturgie and the members its partners in Germany, Austria, France and Italy, to benchmark their productivity. These members are companies with at least one of their business unit active in plastic injection. By using the Innoprod tool while generating the automatic benchmarking report, the company can choose whether it wants a comparison with companies of the same cluster report, a comparison with other European companies report or both. 4

5 1.2. The Innoprod Project The Innoprod project began in This innovative idea of creating a benchmarking tool for plastic injection came from Mr. Yvan Bourqui, responsible for innovation at the Réseau plasturgie and Director Europe & USA for innovation at Johnson Electric. Leader in the field of micro-motors, Johnson Electric uses the injected plastic form for the production of some of its engines. Innoprod is a comparative project on good practices in the production industry. This evaluation brings continuous improvement in the productivity of the business focused on plastic injection. This project is financed by the Réseau plasturgie who acts as the Project Steering Committee for the Science and technology center of the canton of Fribourg and Platinn (Fri-Up). This study was primarily designed for companies within the Réseau plasturgie, but was then extended to other partners Switzerland wide and in the Alpine region through the ALPlastics project. The questionnaire was developed following four workshops between Fri-Up and the first six companies participating in the benchmarking process: Contact WAGO, CEBO BCR Plastics, JESA, Johnson Electric International AG, KBS-Spritztechnik, Mecaplast. The Fri-Up research team was inspired by a benchmark study in the pharmaceutical domain performed by Prof. Dr. Thomas Friedli, a specialist in benchmarking. Therefore, our questionnaire is a transcript of an existing survey in the pharmaceutical sector designed at the University of St. Gallen. Together, Fri-Up and the first six participants adapted this study to make it applicable to the field of plastic injection. The initial survey was made on six companies, all members of the Réseau plasturgie. This stage of the project allowed us to test this first version of the adjusted questionnaire. After this first tests, Fri-Up and the Réseau plasturgie developed the questionnaire to be more precise and optimal. The final questionnaire, used as main information source in the production of the final report, contains 155 questions divided into seven question pools The Innoprod Product Today, the Innoprod product became an online tool on Innoprod was designed in the three spoken languages in the the Alpine Space participating countries: French, German and Italian. The questionnaire is performed online where the companies get a login from the cluster which they belong to. Thus for example from Réseau plastugie for the Swiss companies; from Proplast for the 5

6 Italian companies; from Plastipolis or Carma for the French companies; from Kunststoff Cluster for the Austrian companies; and from Chemie Cluster Bayern for the German companies. The clusters get those rights to add companies from the administrator of Innoprod: Réseau plasturgie. After successfully completing to answer all the questions of the online benchmark form, the company can automatically generate the report in less than a minute. It is important to answer all the 155 questions to establish the benchmarking report. All the questions need to be answered; there is no I don t know option because the questionnaire has been simplified to the maximum. Two different reports are available; the company can choose whether it wants to compare itself only with the companies that are members of the same cluster or with all the companies that completed the questionnaire. When considering all the companies, this means all the benchmark participants, of all European clusters Dissemination in the Alpine Space trough ALPlastics The final product that resulted from the Innoprod project is an online benchmarking tool for the European plastic processing clusters and enterprises. Innoprod was promoted in the Alpine Space though the ALPlastics project. Réseau plasturgie presented the Innoprod project to its European partners from the beginning, in April 2012 in Linz. In January 2013 in Munich the partners got a login to test the tool and later in March 2013 in Fribourg, Réseau plasturgie organized together with Fri Up, a workshop to analyze and comment benchmarking reports. You will find bellow the article about Innoprod in the ALPlastics newsletter N 3: An online benchmarking tool for the European plastic processing clusters: A new online benchmarking tool for the European plastic processing enterprises. Thanks to the Réseau plasturgie (Switzerland) initiative under the Interreg Alpine Space ALPlastics project, the enterprises operating in plastic processing have now a new online benchmarking tool. Developed by taking into account the specificities of the plastic injection-molding field, InnoProd is a key tool for the enterprises in analyzing and comparing their performances with other companies in the same domain. For now, InnoProd is available in French, Italian and German. The concerned enterprises will only have to get a login and to answer some of the 150 questions - estimated time: one hour (without taking into account the data collection work) - in order to obtain a 6

7 direct detailed report from their level of competitiveness with some Total Productive Maintenance, Total Quality Management, Just in Time and Management System indicators. The software allows these enterprises to compare themselves in record time with others from a same cluster, but also - if they want to - with other enterprises from the entire Europe that already have completed the questionnaire, reminding that the data are obviously anonymous. Initially financed by the Science and Technology Center of the Canton Fribourg (www.pst-fr.ch) and Platinn (www.platinn.ch), the InnoProd project has been completed in connection with ALPlastics by the development of the software before being disseminated among the following European clusters members of ALPlastics: Chemie-Cluster Bayern (DE), Clusterland (A), CARMA et Plastipolis (FR), Proplast (IT), Réseau plasturgie (CH). Within the context of the conference Clusters as Drivers of Competitiveness: Policy and Management Issues, the members of the previously mentioned clusters have been trained on March 25th (2013) in Fribourg to a critical analysis of the findings of the InnoProd benchmarking, so that they can optimize their performances improvement in the future. 2. Methodology: Model OPEX (Operational Excellence) The benchmarking questionnaire was established on the basis of the OPEX model (Operational Excellence). The OPEX model is a philosophy of leadership, teamwork and problem solving for a continuous improvement of companies focusing on customer needs, employee accountability and optimization of activities of the various processes. In the specific case of plastic injection it is a productivity improvement. The OPEX model was developed and applied by the University of St. Gallen in the pharmaceutical domain. In order to suit our project, we adapted this approach to plastic injection. Therefore, a transcript of Prof. Dr. Thomas Friedli s model, specialist in the benchmarking area, has been done. The OPEX model we used for the benchmarking of the productivity of the companies having at least one activity unit in plastic injection contains the four indicators as follow: 7

8 (Preven/ve!! Maintenance!( Process(( Management(( Customer!! integra/on(( Time(( management(( and(flexibility(( Pull(( produc/on(( General(( Maintenance(( SelfWdirected(( teams(( TPM( TQM( JIT( Standardized(( equipment( (( CrossW( Technology!! func/onal(( assessment(( product(( and(u/liza/on((( development(( High(con/nuous(( improvement(rates(( Standardized( processes( (( Supplier(( quality(( management(( Low(absenteeism(&( (fluctua/on(( Standardized(( replenishment(( Stable(running(machines( Stable(processes( Low(inventory(( Management(System( Planning(( adherence( Direc/on(seang( Management(commitment(and(company(culture( Employee(involvement(&(con/nuous(improvement(( Func/onal(integra/on(&(qualifica/on(( Layout(( op/miza/on(( Flexible(( workforce(( OPERATIONAL(EXCELLENCE( Figure 1: OPEX model adapted to the benchmarking tool Innoprod In the figure of the OPEX model, the four indicators (TPM, TQM, JIT and Management System) are represented with all the required criteria to optimize the productivity and get the best level of Operational Excellence. In this figure of the OPEX model the company has to enhance the TPM to reach a better level of stable running machines. It also has to improve TQM to increase the level of stable processes and to increase the JIT indicator in order to have an optimal level of low inventory. In the model, the company also has to enhance the indicator management system to reach a better level of self-directed teams, a higher continuous improvement rate, a lower absenteeism & fluctuation and a higher level of most flexible workforces The four indicators (Enabler / Performance) The productivity of the selected companies is benchmarked according to the following four indicators: - Total Productive Maintenance, TPM - Total Quality Management, TQM - Just-in-Time, JIT - Effective Management Systems For each indicator we have Enabler and Performance. The enabler part of the benchmark is done on the basis of questions where the company self-asses itself for the four indicators of the OPEX model. The performance part in the benchmark is based on questions where the company has to answer precise and clear questions with numbers and rates. 8

9 Total Productive Maintenance The aim of the TPM indicator is to have effective fixed assets management that would allow an effective use of new technologies. The Enabler part of the indicator TPM is composed of three groups of questions where the company self assess itself: - Preventive Maintenance - Technology assessment and utilization - General Maintenance The company answers though putting its rank with sliders (from 0% to 100%). The questions related to preventive maintenance are in the group C1; the questions of technology assessment and utilization are in C2; and General Maintenance questions figures under C3. The mean of the results of C1, C2 and C3 gives the result for the TPM Enabler. Then we have the Performance part of the indicator TPM. In order to calculate the level of TPM Performance we use precise rates. The TPM Performance level of the company together with the Enabler gives us an overview of the level of Standardized Equipment. If the result is not satisfying and needs to (or can) be improved, then the company can identify its weaknesses and try to have a better TPM to reach an optimum level of Stable running machines through the benchmarking report Total Quality Management We seek to increase the quality of production with the TQM indicator. For this indicator, again, we have the Enabler and the Performance part. The TQM Enabler contains four criteria or group of questions. The first one is about the process management in the company. The second criteria is about the level of cross-functional product development, where information about the collaboration between the different departments and meeting of deadlines are collected. The third criteria to define the level of TQM is the customer integration; we would like to know if the company cares about customer satisfaction and if they collaborate for innovation. The fourth important criteria in defining the level TQM is the quality management of supplier, were we would like to know the collaboration intensity between the company and the supplier, but also the specific way that the company chooses supplier. After collection, the information for the four question groups of the TQM Enabler we proceed to the mean of answers. 9

10 There is also the Performance of the TQM were we collect information about the customer compliance rate, the supplier compliance rate, rate of rejected consignments, average outgoing quality, the number of collaborator for the quality and the quality cost. This part contain clear rates. If the company doesn t overestimate itself then its Performance and Enabler ranking in the benchmarking should be closed. The TQM will tell about the level of standardized processes of the company and help it to identify weaknesses in order to reach a better level of stable processes that will imply a better Operational Excellence level in general for the company Just-In-Time The JIT indicator aims to reduce the working capital while increasing the level of service. For the JIT indicator of the OPEX model we also have an Enabler part and a Performance part. The Enabler part is composed of four groups of questions. The first is about the time management and the flexibility. In this first group we want to identify how optimal the production cycle is. The second point of the JIT Enabler is the pull production, where we ask questions about when the production is launched and how far the company can rely on its suppliers, and if there is a stock. The third group of questions is about the layout optimization; here we want to know if the factory is well organize to simplify work and gain time. The last criteria of the JIT Enabler is the planning stability, we want to know if the company meets its daily production and the reliability of the planning of the factory. The mean of all the Enabler question groups together gives the general JIT Enabler. The JIT performance is composed of the ratio raw material stock rotation, the ratio finished product rotation, the average number of mold changes per machine per month, the average change time, the rate of confirmed delivery date to customer and the rate of confirmed delivery date to supplier. The mean values of all those criteria define the JIT Performance level. The Indicator JIT can, thanks to the benchmarking calculations, present the level of standardized replenishment of the company. The fact that the company has the opportunity to position itself trough the benchmarking report will allow to chose the needed measures to reach an optimal level of low inventory. 10

11 Effective Management Systems Finally, the management systems indicator aims at assuring that the company is operating under clear objectives. This indicator is also divided in Enabler and Performance, as the previous three indicators. The Enabler part is composed of three sections: Management by objectives, Management commitment and corporate culture, Employee involvement and continuous improvement, and Functional integration and qualification. The first question group management by objectives concerns the vision of the company, the resource management system and the manufacturing director. The corporate culture and cooperation between departments are developed in the second section, management commitment and corporate culture. The third question group about employee involvement and continuous improvement contain information about the ability of multitasking of the employees and their involvement. In the last group of question of Management System Enablers is about the flexibility of employees, their trainings as well as information transfer and meetings. In the Performance part of the OPEX indicator Management System we will collect numbers and rates in order to define following points: the number of hierarchical levels, the employee turnover, the sickness absenteeism, the training, the security level, the versatility. Thanks to the indicator Management System weaknesses can be identify to take actions to have a higher level of self-directed teams, high continuous improvement rates, a low absenteeism & fluctuation and as well a higher level of flexible workforces. Those improvement actions will lead to a better Operational Excellence level of the company. 3. The Questionnaire Only the plastic injection part of the business is assessed. That's why we must be careful not to take into account the employees who do not work in plastic injection. Otherwise, it can greatly affect the results related to productivity. The first time that the company logs in on the Innoprod Website to answer the questionnaire, we ask for the reference year and the currency. The reference year is the year for which the information and rates are chosen. For example even if we are in 2013, a company could have the numbers and rates of the year 2011 and not yet for 2012 or In this case, the company will enter its reference year and the questionnaire and the report will automatically take this information. The choice of currency is important because we have Swiss company working with Swiss Francs and European companies 11

12 working with Euro. Here the company has to enter whether it works with Swiss Francs or Euro because there is a part in the questionnaire where we ask about costs. The company has to give information about the exchange rate it has been used. We will use the exchange rate for benchmarking report where including Swiss and European companies Overview of the seven question pools of the questionnaires There are seven different question pools in the online questionnaire for the Innoprod benchmarking tool. In those pools of question, the important information for the presentation and the comparison of the production structure and the four indicators of the OPEX-model (Enabler and Performance) are collected. The questionnaire is done in a smart way where only necessary and useful information for the benchmark is asked about. Thus, all the questions have to be answered, by self-assessment for the Enablers and with precise numbers for the Performance. When we write {year} it means the company enters the year (reference year). It is the same for {currency} where the company has to chose between Swiss francs and Euro. Letter Question pool Comment A Your company In this group of questions, you will fill it with general information about the company and the production site. B C D Cost structure and workforces of the site in {year} Total Productive Maintenance System Enabler Total Quality Management System Enabler This pool of questions contains information about the cost structure of the production site and the number and occupation rate of the collaborators. In the section C, there are the questions for the enabler part of the indicator TPM. In the question pool D, you will answer questions for the enabler part of the indicator TQM. E Just in Time System Enabler This group of question contains information about the time management and other characteristics of Just in Time indicator. F Management System Enabler This pool of questions F is about the management, the 12

13 corporate culture and the employees. G Performance of the company The section G contains all the questions that will be used for the performance of the four indicators. In this questions pool, clear answers are required, with numbers, costs and rates Question pool: A. Your company In the table bellow, the entire questions related to the first group are listed and commented. Question# Question Answers Comments A1 Type of the sample 1. Subcontractor, contract work (no development) In this question we would like to know the type of the work done by the company. The possible answers to this question are yes or no; if the considered production site does subcontracting work. 2. Finished products The possible answers to this question are yes or no. Here we would like to know if the company is doing finished products. 3. Semi-finished products Here the possible answers are yes or no. We would like to know if the production site of the company produces semi-finished products. A2 Sourcing by region 1. Western Europe In this group of question, the 2. Eastern Europe 3. North America 4. South America company put the percentage of sourcing from each region. To save the answers and not get an 5. Middle East error message, it has to have a 6. Asia total of 100%. In the last line we have a special space with the sum 7. Rest of the world to help. A3 Geographic segmentation of customers 1. Western Europe In the question A3, we would like 2. Eastern Europe to know where the customers are 3. North America located. The answers are in %. 4. South America The sum has to be equal 100%. 5. Middle East 6. Asia 7. Rest of the world 13

14 A4 Production structure 1. Molds In the question A4, the company 2. Multi-component is asked to put the numbers of molds produced molds, multi-component 3. Over molds molds and over molds in the reference year. A5 Vertical integration of production in {year} 1. Percentage of colored materials on-site 2. Percentage of hot runner molds 3. Percentage reuse ground materials In this question, the answers are in %, where the company specifies some information about the production. Here we would like to know how much of the materials is colored on site, the percentage of hot runner molds and the percentage of the materials that are reused after grinding. A6 Innovation structure and audit 1. Number of new products launched in the past three years (new for production) 2. Number of audits on the site over the past three years by an official certification body 3. Number of audits on the site over the past three years by a internal body of the company 4. Number of audits on the site over the past three years by a client In this question we need a number as answer; the number of new production in the production line and the numbers of audit by an official certification body, an internal body of the company or a client. A7 Age of the production technology in {year} 1. Percentage of machines that have less than 5 years 2. Percentage of machines that are between 5 and 10 years 3. Percentage of machines that are between 11 and 20 years 4. Percentage of machines that have more than 21 years The sum of the 4 possible answers must be equal to 100%. Here we would like to know the age of the machines of the production site. A8 Degree of automation in {year}: How is the product output on your various machines? 1. Manual output In this question the sum has to be 2. The product fall from equal to 100%. Here we would itself in a box like to know the degree of 3. The output is done on a automation for the output of conveyor belt products. 4. The output is done by a robot and put on a 14

15 conveyor belt 5. Output is through a robot that conditions directly in the packaging A9 Degree of automation in {year}: How is the process of grinding carrots? 1. Using a mobile juxtaposed crusher 2. With a centralized system for grinding 3. No grinding The sum of the three possible answers has to be equals to 100%. Here we would like to know the percentage for the automation of grinding carrots. A10 Degree of automation in {year} 1. Centralized supply of granules (% of total materials used) 2. Automated quality control on the machine (% of equipped machines) We would like to know more about the degree of automation in the production and equipment. The answers are in percent. There is no link between the two questions, no constraints for the sum Question pool: B. Cost structure and workforces of the site in {year} In the table bellow, the entire questions related to the second group of questions Cost structure and workforces of the site in {year} are listed and commented. Question# Question Answers Comments B1 Costs of materials 1. Costs of raw materials, including other components of the product 2. Consumable costs of production necessary to operations and other services Here we have the cost in the currency that the company chooses at the beginning of the questionnaire (during the first login). The cost are whether in Swiss francs or in euro. B2 Cost of manpower 1. Direct Costs of laboratory staff involved in the production 2. Indirect costs of management of the laboratories directly involved in the production 3. Costs of production quality support B3 Maintenance costs 1. Costs of cleaning and maintenance of buildings, machinery, Here we have the direct and indirect cost of manpower related to the production. The company at the begging of the questionnaire and only once will have to choose the currency (Swiss Francs or Euro). Here we have all the cost of maintenance in the selected currency (Swiss francs or euro). 15

16 B4 Number of collaborators in {year} (Full Time Equivalent) tools and molds, including electricity, water, etc. 1. Production Here we would like to know the 2. Packaging number of FTEs for each activity. 3. Quality Control Please mention the number of (quality tests, analysis, FTE even if they don t figure on batch control and the payroll. shuttlecocks, approval) 4. Quality Assurance (certification processes, work procedures and measures, quality studies, quality planning) 5. Purchasing, Inventory, Logistics 6. Maintenance of equipment: machines, molds, devices 7. Environment, Health and Safety 8. IT Support 9. Other (Sales, general management and administrative) B5 Number of permanent and temporary employees in {year} 1. Percentage of fix employed FTE people (permanent contract) 2. Percentage of temporarily employed FTE people (fixed-term contract) The sum of the two answer is equal to 100%. Here we would like to know the percentage of fix and temporarily employed people Question pool: C. Total Productive Maintenance System Enabler In the table bellow, the entire questions related to the group of questions C about the indicator TPM enabler are listed and commented. This group is composed of enabler question, all the answers are represented with sliders where the company self-assesses itself by telling between 0% and 100% how much it fits with the proposed answer. Question# Question Answers Comments C1 Preventive Maintenance 1. We have a formal program for the maintenance of our machinery and equipment. Here we want to know of the maintenance program is clearly defined and documented. 16

17 2. We identify a good maintenance as improving strategy for the quality and compliance planning. 3. All machines with potential bottlenecks are identified and provided with additional spare pieces. 4. We continually optimize our maintenance program based on an analysis of failures. 5. Our maintenance service involves and trains machine operators to fulfill their own preventive maintenance. 6. Our operators are actively involved in the process of buying new machines. 7. The maintenance of our machines is mainly internal. We avoid as much as possible the intervention of an external service. Maintenance is important for the company; it is a synonym of goo quality. The bottlenecks have a big impact on the productivity. The more you care about it, the better your production will be. Failures are analyzed. The maintenance program is continuously improved from learning through failures. There is a person responsible for the machine and the company trains this person to empower it and have a better maintenance of the machine and equipment. The operators of machines know a lot about the machines they are responsible for. Involving them in the buying process is an added value. The empowerment of the responsible persons for the maintenance, intern to the company, gives more flexibility to the production and raises the productivity. C2 C3 Technology assessment and utilization General Maintenance 1. Our factory is at the forefront of new technologies in our field. 2. We are constantly looking for new production technologies on the market. 3. We develop new technologies internally. 4. Increased level of automation. 1. Our employees are committed to keep our factory clean and in order. 2. Our factory procedures insist that all tools and accessories are in place. 3. We have a checklist of In this section we would like to know how much the company cares about mew production technology. Those questions are very important, because a weak position in the benchmarking of the productivity could be caused by an inappropriate or obsolete technology. It is very important to k now if the factory is in an optimal condition for work. A weak general maintenance can have a huge negative impact on the productivity of the production site. 17

18 maintenance to continuously monitor the condition and cleanliness of our machines and equipment Question pool: D. Total Quality Management System Enabler In the table bellow, the entire questions related to the group of questions D about the indicator TQM enabler are listed and commented. This group is composed of enabler question, all the answers are represented with sliders where the company self-assesses itself by telling between 0% and 100% how much it fits with the proposed answer. Question# Question Answers Comments D1 Process 1. Processes are well Management documented in our company. 2. We regularly measure the quality of our processes using indicators. 3. The company has delegated to its responsible for process the planning, management and improvement of their processes 4. A large percentage of the production is under statistical control (SPC). 5. We analyze the causes of failure using standard tools (DMAIC, FMEA, Ishikawa,...) 6. Monitoring and control processes in real time. 7. Reduction of rate of waste. This part contains information about the processes in the company. We want to know if there is standard, so if they are clearly documented. For the measure of quality of processes we want to know if the company is oriented continuous improvement. The task of the process responsible is very important and has a huge impact on the productivity of the site. SPC: Statistical Process control is a method of quality control using statistics. DMAIC is an abbreviation of the five improvement steps: Define, Measure, Analyze, Improve and Control. FMEA: Failure mode and effect analysis is a systematic technique for failure analysis. Ishikawa method explains the cause of a specific event. D2 Cross-functional product development 1. Thanks to a close collaboration between R & D and manufacturing, we have reduced the time to launch products on the market ("scale-up"). In this section we would like to identify the level of collaboration between the different departments. A good collaboration can reduce time of launch of new products and reduce the risk of delay. We also want to know if the way of 18

19 D3 D4 Customer integration Supplier quality management 2. We do not have delays in the launch of new products in the past two years. 3. For the transfer of product and process between different departments and production sites there are standardized procedures to ensure rapid, stable and consistent transfer of knowledge. 1. We regularly carry out satisfaction surveys of our customers. 2. We regularly receive qualitative Evaluations from our customers. 3. We are looking among our customers for sources of innovation for our company and our product. 4. We collaborate with our customers to develop improvement programs to increase our performance. 1. In selecting suppliers, quality is our first criterion. 2. We conduct qualifications and audits on our suppliers 3. We systematically inspect our received goods 4. We conduct together with our suppliers improvement programs to increase our performance. collaboration is standardized in the company. Here we would like to know in how far the company listens to its customers, as well as on the customer satisfaction level as on the innovation possibilities trough collaboration with them. D4 is meant to identify how the company chooses its suppliers and if the relation between the is built on trust. We also would like to know how intensively the company and the suppliers work together to increase the overall performance level Question pool: E. Just in Time System Enabler In the table bellow, the entire questions related to the group of questions E about the indicator JIT enabler are listed and commented. This group is composed of enabler question, all the answers are 19

20 represented with sliders where the company self-assesses itself by telling between 0% and 100% how much it fits with the proposed answer. Question# Question Answers Comments E1 Time management and flexibility 1. Time reduction of machine cycle 2. We are constantly working on decreasing the installation time of production. 3. Time reduction for cleaning equipment 4. To increase flexibility in our factory, we focus on reducing the size of the lots. 5. The assembly process is documented as "Best Practices" in the factory. 6. Focus on a program for reducing delivery times 7. Accuracy of deliveries (on-time ratio) E2 Pull production 1. Our calendar includes the projected customer orders (Forcast) E3 Layout optimization 2. We use a "pull" system (tickets Kanban containers or visual signals) 3. We prefer a long-term partnership with suppliers rather than to change frequently. 4. We can rely on our suppliers to meet the agreed delivery times. 5. Instead of focusing on the stock approach, we ship to our customers according to a "JIT" oriented request. 1. Our processes are close to each other so that the handling is minimized (Lean) 2. The products are classified into groups of similar requirements processes to reduce the installation time of a The time management has a huge impact on the productivity of the company. We would like to know if the company take actions in order to reduce time, size of the lots and increase flexibility. In this part we would like to know how the company manager the orders from the suppliers and the production. The disposition of the machines according to the production process can have an influence on the productivity. Here we would like to know how optimal this layout is. 20

ICH Q8, Q9 and Q10. Krishnan R. Tirunellai, Ph. D. Bureau of Pharmaceutical Sciences Therapeutic Products Directorate Health Canada December 4, 2008

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