For companies that want to increase their flexibility and at the same time reduce their stock levels, it is critical to minimize the times for both tool changes and preparations.
Eliminate the concept of a manufacturing batch by minimizing the preparation time of machines and materials, this is in essence the SMED philosophy. Today it is committed not only to reduce preparation times to a minimum, but also repair and maintenance times.
SMED is the acronym for Single Minute Exchange of Die: tool change in (few) minutes. This concept introduces the idea that in general any machine change or process initialization should last no more than 10 minutes, hence the phrase single minute (expressing the minutes in a single digit). Tool change is understood as the time elapsed from the manufacture of the last valid part of a series until the obtaining of the first correct part of the next series; not only the time of change and physical adjustments of the machinery.
Fundamental concepts of SMED
For the purpose of reducing preparation times, four key concepts must be taken into consideration, consisting of:
1. Separate the internal preparation from the external one. Internal preparation should be understood as all those activities for which it is necessary to stop the machine or equipment. While the external includes all those activities that can be carried out while the machine is in operation.
2. Convert as much of the internal preparation as possible into external preparation. In such a way, many activities that must in principle be carried out with the machine stopped can be advanced while it is in operation.
Example: The pressure casting machine can be preheated using the excess heat from the oven that serves this machine. This means that the test shot to heat the metal mold of the machine can be eliminated.
3. Elimination of adjustment processes. Adjustment activities can represent between 50 and 70 percent of total internal activities. For this reason, it is important and imperative to systematically reduce the setting time in order to reduce the total preparation time. The key is not to reduce the setting, but to "eliminate" it through creative thinking (eg, adjusting the tools in one motion - one touch up).
4. Delete the preparation phase itself. In order to dispense with preparation entirely, two criteria can be adopted. The first is to use a uniform product design or to use the same part for different products; and the second approach is to produce the different parts at the same time. The latter can be achieved by two methods. The first method is the set system. For example, on the same die, two different shapes are carved. The second method consists of punching the different pieces in parallel, using several lower-cost machines.
OTED
A more advanced concept related to SMED is One-Touch Exchange of Die, (OTED), which posits that changes should be made in less than ten seconds.
KAIZEN
The kaizen method of continuous incremental improvement is an originally Japanese concept of managing for gradual, continuous (incremental) change (improvement).
Kaizen is truly a philosophy of life. It assumes that every aspect of our life deserves to be constantly improved. The philosophy of Kaizen rests behind many Japanese management concepts, for example: total quality control, quality circles, small group activities, and working relationships.
The key elements of Kaizen are: quality, effort, commitment of all employees, willingness to change, and communication.
Japanese companies differentiate between: Innovation, a radical form of change, and Kaizen, a continuous form of change.
Kaizen literally means: change (kai) to become good (zen).
The five basic elements of Kaizen
- Personal Discipline Improved Moral Quality Circles Suggestions for Improvement
The “5-S” movement takes its name from five Japanese words that begin with “s”: seri, seiton, seiso, seiketsu, and shitsuke. As part of the visual management of an overall program, signs repeating the steps are often placed in the workshop…
STEP 1, SEIRI (straighten): Work in process, unnecessary tools, unoccupied machinery, defective products, papers or documents.
Differentiate between what is necessary and what is unnecessary and discard what is unnecessary.
STEP 2, SEITON (put things in order): Things should be kept in order so that they are ready to be used when needed.
STEP 3, SEISO (cleanup): Keep the workplace clean.
STEP 4, SEIKETSU (personal hygiene): Make cleanliness and neatness a habit, beginning with the person himself.
STEP 5, SHITSUKE, (discipline): Follow shop or work area procedures.
When should the Kaizen philosophy be applied? Although it is difficult to give generic advice, it is clear that this philosophy works well in situations of gradual, incremental change that require changes in the long term and in collective cultures. More individual cultures that focus more on short-term success are often more conducive to the use of concepts such as business process reengineering.
KAIZEN COMPARED TO THE REENGINEERING OF THE BUSINESS PROCESS
When Kaizen is compared to the BPR method it is clear that the Kaizen philosophy is more man-directed, easier to implement, but requires long-term discipline and provides only a small step of change. The Business Process Reengineering approach, on the other hand, is tougher, technology-oriented, allows for radical change but requires considerable Change Management skills.
POKA YOKE
A poka yoke (Literally error-proof) is a device (generally) intended to prevent errors; Some authors handle the poka yoke as an anti-fool system which guarantees the safety of the users of any machinery, process or procedure, in which they are related, in this way, not causing accidents of any kind; Originally, poorly manufactured parts were still in process with the consequent cost.
These devices were introduced to Toyota in the 1960s by engineer Shigeo Shingo within what is known as the Toyota Production System. Although poka yokes previously existed, it was not until their introduction in Toyota that they became a quality technique, today common.
Types of errors caused by the human factor in operations
To forget. The forgetfulness of the individual.
Misunderstanding. An incorrect / inadequate understanding.
ID. Identification is missing or inadequate.
Beginner / Novatez. Due to lack of experience of the individual.
Purposeful mistakes for ignoring rules or policies. On purpose due to ignorance of rules or policies.
Unnoticed. Due to carelessness, some situation goes unnoticed
Slowness. Due to the slowness of the individual or something related to the operation or system.
Lack of standards. Lack of documentation in procedures or standards of operation (s) or system.
Surprises For lack of analysis of all the possible situations that can happen and surprise.
Intentional. Due to lack of knowledge, training and / or integration of the individual with the operation or system, there are intentional causes.
Classification of Poka-yoke methods
- Contact methods. They are methods where a sensitive device detects abnormalities in the finish or the dimensions of the part, where there may or may not be contact between the device and the product. Fixed value method. With this method, abnormalities are detected by inspecting a specific number of movements, in cases where the operations must be repeated a predetermined number of times. Step-movement method. These are methods in which abnormalities are detected by inspecting errors in standard moves where operations are performed with predetermined moves. This extremely effective method has a wide range of application, and the possibility of its use should be considered whenever the implementation of a Poka-Yoke device is being planned.
QUALITY SYSTEMS
In today's globalized world, it is increasingly necessary to have tools that allow measuring the quality of the processes used by each one of them, especially in the business environment, since the manufacturers of final products commit to users to provide quality products, risking the prestige of the company.
For this reason, having quality guarantees for the materials and components that suppliers deliver can determine the success or failure of a product, and even a company.
Faced with this situation, the idea arose of developing global standards, in various fields, that allow a company to determine, on a real basis, the quality that a company or a product can offer.
Currently, the best known and most widely used standards are those developed by the International Organization for Standardization, better known as ISO.
The need to have certain guarantees about the quality and commitment of a company, and the great popularity of ISO standards, have caused that having an ISO certification has practically become a necessity, given the growing number of companies who demand that their suppliers have such a guarantee, to agree to do business with them.
ISO 9000
The ISO 9000 standards are "quality" and "continuous quality management" standards, established by the International Organization for Standardization (ISO) that can be applied in any type of organization or systematic activity, which is oriented to the production of goods. or services. They consist of standards and guides related to management systems and specific tools such as audit methods (the process of verifying that management systems comply with the standard).
Its implementation in these organizations, although it involves hard work, offers a large number of advantages for companies, among which are:
- Improve customer satisfaction Continuously improve processes related to Quality Reduction of rejections and incidents in production or service provision Increase in productivity
The family of standards first appeared in 1987 on the basis of a British Standard (BS), and was mainly extended from its 1994 version, currently being in its 2008 version, published on November 13, 20081.
The main standard of the family is currently: ISO 9001: 2008 - Quality Management Systems - Requirements.
Another binding standard to the previous one: ISO 9004: 2000 - Quality Management Systems - Operational improvement guide.
The ISO 9000 standards of 1994 were mainly designed for organizations that carried out a production process and, therefore, their implementation in service companies was very hard and that is why they continue to believe that it is a rather bureaucratic system.
With the 2000 revision, a much less bureaucratic standard has been achieved for organizations of all kinds, and it can also be applied without problems in service companies and even in the Public Administration.
To verify that the requirements of the standard are met, there are certification bodies that issue their own certificates and allow the seal. These entities are supervised by national bodies that give them their accreditation.
For the implementation, it is very convenient for the organization to be supported by a consulting company, which has good references, and the firm commitment of the Management that it wants to implement the System, since it is necessary to dedicate time from the company staff to implement the Quality management system.
ISO 9000 Family of Standards
- ISO 9001: Contains the specification of the management model. It contains "the requirements" of the Model. The ISO 9001: 2008 standard contains the requirements that quality systems must meet for internal trust, contractual or certification purposes. ISO 9000: These are the fundamentals and vocabulary used in the ISO 9001 standard.
Currently in version 2005.
- ISO 9004: It is a guideline for improving the performance of the quality management system ISO 19011: It specifies the requirements for conducting audits of an ISO 9001 management system, for the occupational health and safety management system specified in OHSAS 18001 and also for the environmental management system specified in ISO 14001.
TS-16-949
ISO / TS 16949 year 2002 responds to the transition of the International Standard ISO 9001 and harmonizes the requirements for the automotive sector.
ISO / TS 16949 is the variant, technical specification, of the International Standard ISO 9001 specifically for the automotive industry, direct suppliers to assemblers. The ISO / TS 16949 recognition scheme is administered by the "International Oversight Bureau (IOB)" for the purpose of:
- Implement and manage the ISO / TS 16949 registration scheme Assist in providing consistency of the ISO / TS 16949 registration scheme Support the "IATF (International Automotive Task Force)" in the task of globalizing ISO / TS 16949 Implement and maintain a database and information
ISO / TS 16949: 2002 establishes implicit provisions for continuous improvement, defect prevention, variation reduction and value-added factor in the supply chain ("Supply Chain"). Other important / affected inclusions include; staff competence (include training and awareness factors), design and development, production, process approach, meet regulatory requirements (legal and industrial), measurement and control, analysis and improvements.
The main manufacturing companies in the automotive sector are members of the international group "IATF" include: DaimlerChrysler, General Motors, Ford, Fiat, PSA Peugeot Citroën, Renault, BMW, Volkswagen…
Brief Explanatory ISO / TS 16949
ISO / TS 16949: 2002 comes to replace and therefore harmonizes the combined management schemes to the VDA 6.1 (German Automotive), EAFQ (France), AVQS (Italy)… and QS-9000 (American Automotive) regulations. ISO / TS 16949 is considered favorable to the previous management schemes (which it replaces), making it easier for companies to avoid the duality of systems such as VDA 6.1, EAQF, QS-9000… by manufacturers in the automotive sector…
VDA
VDA 6.1 is a German quality standard. It was started by the automobile industry. Therefore the VDA 6.1 standard contains the Quality Management System for the German automotive industry.
Verband der Automobilindustrie e. V. (VDA) issued in December 1998 the fourth edition of this standard, which became mandatory for all German automotive manufacturers since April 1, 1999.
The VDA standard is divided into two parts, the first of which refers to management and the second to products and processes. When the audit is carried out, the company must achieve at least 90% correct answers, to obtain the certification.
Other requirements
The VDA 6.1 standard contains all the elements of QS-9000, plus four additional requirements:
- Recognition of the risk of the product They are the risks of the product to fulfill its function and its effects on the whole set Employee satisfaction It is the perception that its employees have of the company, as well as their needs and expectations to be fulfilled through a focus on company quality Quotation structure Products are offered to customers or the market for purchase or intended for own use Quality background The system describes the quality background of products provided to customers and provides an overview of the situation during a particular period.
The VDA standard is divided into two parts:
Products and Process Management.
Certification.
Any company seeking certification must achieve at least 90 percent in formal compliance with a quality audit.
ISO 13485 Medical Devices
The medical equipment industry is affected by a complex series of regulatory systems, national and international standards and other requirements. We offer services that help manufacturers understand what they need to do to make equipment on the market compliant around the world.
ISO 13485 is the most recent version of ISO 13485, a standard published in July 2003. This standard is based on the ISO 9001 process model approach.
We are formally recognized under the regulatory systems of Europe and Canada and we are committed to achieving formal recognition under the regulatory systems of the US and Japan as these evolve and opportunities arise.
Regardless of the equipment you manufacture, as a medical equipment manufacturer you have a responsibility to consistently supply safe and effective equipment. ISO 13485 the recognized international standard to regulate medical equipment around the world.
