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Midwest QualityTM

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LeanAgile®

ISO Improvement Engine  Lean and Agile program

Midwest has been involved in quality improvement along with registration activities for 8 years.  We are proud to integrate the improvement into your registered quality system, not tack it on as an extra project.  We even know how to integrate Six Sigma programs.

We are likely less doctrinaire than most, but we find as usual thet one size does not fit anyone let alone all, and the program gas to be matched with your situation and company culture.

We have 2 basic approaches, which are not exclusive.  The first is the "improvement engine" built into ISO 9001:2000, and the second is a Toyota Production Systems based program to reduce production time and costs for tangible goods and services.

ISO based improvement

    The following 16 points highlight some of the ISO 9001:2000 clauses which, when implemented together as a Quality System, will lead to the greater success in the Organization. The underlying power is a new "ISO capability" for top managers to be able to push ahead on all of these fronts simultaneously, without their direct intervention, but by the coordinated action of the ISO team.

  1. General requirements (4.1). In these clauses top management has to "identify the organization’s processes … determine their sequence and interaction…" This requirement helps focus the organization on those processes which deliver value to the customer. These will be monitored to see that they are working as expected (see #13 below). Understanding which process you need to get right is a critical first step.
  2. Establish and deploy the quality policy and objectives (5.3 & 5.4.1). These clauses focus the entire organization on the same goals. It is optimum to have measurables which each person could tally up at the end of the day to see how they did. These individual measurements are totaled by "department" or area, and finally for the. Top management can see the overall trends, and "drill down" to see the drivers, and offer congratulations or provide resources as necessary. Such "pyramid" metrics (from a broad base to one point at the top) are difficult to devise, but very valuable to drive change across the board.
  3. Responsibility and authority and Internal communication (5.5.1 & 5.5.3). People need to be crystal clear about their responsibility to carry out tasks and their authority to allocate resources and make decisions. Maintaining people’s roles so that there is clarity, and maintaining these current in today’s dynamic organizations requires excellent communication. These aspects are business 101 issues, but almost every organization needs to improve to prevent politics interfering with responsiveness.
  4. Competence, awareness, and training (6.2.2). An organization is people, and humans all need help. Building, maintaining and growing the competence of the employees is the heart of the organization, and a substantial expense. This area is a great opportunity.
  5. Infrastructure and work environment (6.3 & 6.4). People need the tools of the trade and the environment (including a psychological environment) to do their best. As with competence above, these areas present a huge opportunity. Remember, section 6 is the "plan" section where top management prepares the people to "do" in section 7.
  6. Planning for product realization (7.1). Each "product" requires planning to determine and provide the specific resources people need to do the work correctly and profitably. An organization typically has many such plans for various activities. This clause brings these together as a system, and establishes a new product planning process to introduce new items. Change is the goal of the ISO program, and this clause addresses product changes needed to grow sales.
  7. Customer related processes (7.2). These clauses are the heart and soul of ISO 9001. Once you know and agree to provide something, the rest of ISO is really there to ensure that you know you provided what you agreed to provide. Review of the customer orders is one of the ways the organization addresses this issue, and might benefit from the details of the ISO considerations. This clause also includes customer communications which are always a problem when personnel are not in the office.
  8. Design and development (7.3). Many organizations do not do design, but for those who do ISO has a simple formula to recommend. The section addresses the need to design, verify and validate the product, and track progress to completion. The design function can be simple or complex, and this section facilitates control. Time is often a forgotten issue in the design process.
  9. Purchasing (7.4). The organization needs "raw materials" which go into the products, and spending is always an issue; and this clause addresses the need to control spending. There is a huge change going on in the purchasing world relating to just-in-time and "supplier partnerships." This clause encourages simple goals in navigating through these changes.
  10. Service provision (7.5). These clauses govern the quality, quantity, and cost of the work people do off-site. Many organizations have no service in this sense. Addressing service helps ensure that what happens at the customer location is as well controlled as the work on the factory floor, with QC, maintenance, and management there for support.
  11. Customer satisfaction (8.2.1). ISO requires that the organization "monitor information relating to customer perception." When done well, addressing this clause provides an excellent early warning system as to how the customers are reacting to changes within the organization. Change is the purpose of the Quality System, and finding about unhappiness in a customer after they leave allows little room for correction during change.
  12. Internal audit (8.2.2). A good internal audit "listens" to the organization and presents a fact-based answer to a question from to top management, to help them determine the need for change. Audit can be a routine checking on the status of aspects of the business, or an emergency response to a problem. In all cases it is a way for management to obtain information to help them decide and act correctly.
  13. Monitoring and measurement of processes (8.2.3). The important processes within the organization are measured, and the results compared to plan to see where progress is acceptable, and where resources are needed. This is another of the ISO feedback loops to keep management aware of how change is progressing within the organization.
  14. Monitoring and measuring of product (8.2.4). This clause requires that you have information that the service provided to your customer meet the criteria you agreed to with the customer in 7.2. This is what most people think of as quality, and it is of crucial importance in just-in-time, "lean" world. It is useful to point out that the activities of "inspection" are not value-added to the customer. This area is of potential significance.
  15. Control of nonconforming product & analysis of data (8.3 & 8.4). This clause requires that when someone makes a mistake, the organization has to do something to ensure that the problem does not get out to the customer. But this clause allows you to "listen to the processes" to collate and present what is going wrong (not done right the first time) so that resources can be provided in a prioritized manner to prevent reoccurrence. So billing errors, late and absent employees, computer malfunctions, scheduling problems, machine downtime, late work, etc. can all be tracked as appropriate to see that change is happening. It does not take data to see that something changed by half (twice as many reports are late) but it does take data to detect a slight.
  16. Corrective and preventive action (8.5.2 & 8.5.3). These clauses require systems for fixing significant problems. This is the formalization of the organization’s risk management program. The management question is not that problems exist, but which one is the next most important for the organization to spend resources on to fix now? These clauses require that the organization track the formal projects which management assigns to drive change. Many other aspects of the standard drive change as well, and the organization has to have a system to and then make sure it is fixed before moving on to the following issue.

Meet the requirements of the ISO standard, and a business will have the organization and focus which will achieve the policy and objectives set by top management. When these relate to increased sales and reduced costs the organization profit will increase, and the managers will become true believers that ISO is an important tool.

Lean and Agile

Toyota Production Systems talks about eliminating waste: the 7 normal kinds of waste (see below), the waste of overproduction, and the waste of over-stressing your systems.  The 7 Toyota classifications of waste are:

  1. Rework and nonconforming material
  2. Waste of over-production
  3. Waste in processing
  4. Waste in transporting and moving
  5. Waste in inventory
  6. Wasted motion
  7. Waste in waiting

So what do we do about it?

We work with you to develop a program, which would include variations on the followng steps:

  1. Flowchart the selected process from the customer and suppliers and back to the customer. This will identify the operations. Immediately look overall at opportunities for reducing steps, waiting, inventory, etc.
  2. Establish a baseline of current production, uptime, costs, Cpk, quality issues, rejects, etc. Accurately determine current levels of customer satisfaction and identify all customer issues. Document current activities with digital photos or video.
  3. Post a summary of the current situation on a project bulletin board in the manufacturing area. This will be maintained as the project matures so all can understand the process.
  4. Start to keep score of hourly production compared to rate, and report all quality defects found. Start a regular management review of the score-board.
  5. Clean-up with the 5S program (Productivity Press), add paint, work benches, storage, lighting etc. as required by that program. This activity merges with the next step.
  6. Determine material flow system: raw materials, finished goods, supplies, waste, identification, containers, etc. Look for ways to reduce inventory and motion.
  7. Plan TPM (Total Preventive Maintenance Productivity Press) to eliminate all downtime, track downtime improvements.
  8. Plan SMED (Single Minute Change of Dies Productivity Press) for rapid tooling changeovers.
  9. Do FMEA (Failure Mode and Effects Analysis AIAG) to develop appropriate Mistake-Proofing devices/activities to detect and prevent passing defective parts.
  10. Micro-flowchart/time study operations to re-arrange the equipment in a cellular fashion to reduce travel and movement, plan the operation at different volumes with the appropriate number of operators.
  11. Micro-flowchart/time study the cellular operations to further reduce movement and establish standard work with instructions, incorporating the Mistake-Proofing, TPM, and SMED results.
  12. Watch the production/quality numbers on the scorecard and eliminate the issues which prevent making rate or create any defects. Keep improving standardized work instructions/TPM/SMED.
  13. Reduce inventory and prefect the pull (KanBan) minimal inventory system.
  14. Partner with suppliers to reduce their inventory and incorporate their quality results.
  15. Plan continuous improvement activities to improve the rate. Audit to ensure accuracy of standard work instructions. Review FMEA to further reduce likely failures.
  16. Select the next area for improvement, reiterate process. The machining areas with small or one-piece production will be slightly more challenging in that the "standard" work will have to become similar to an auto repair shop where they are allocated hours. However, the rest of LeanAgile™ applies. Do not forget the office areas, sales, quoting, design, purchasing, where LeanAgile™ can make a big difference.

If you are interested, contact us!

 

For More Information Contact: tony@midwestquality.com or 800 464-9008 

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