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| ISO Quality Management Systems
Large, world class companies can be very demanding of their suppliers--they require a formal quality system, supported by top management.
- Potential customers request the company "Quality Manual" or ISO
registration or want to see audits and data from your processes. Business is lost because because you don't have these.
- Processes are usually passed along by "word of mouth" or "tribal
knowledge," degrading efficiency when someone resigns, is out on leave
or vacation, or a new employee needs training.
- The costs of resolving customer complaints are increasing.
The ISO 9000 standard is the gold standard for developing a Quality Management System (QMS) for most companies (exceptions: drug, medical device, vehicle manufacturers). If your company is going to compete, you must address the cost of quality and a system to define, monitor and improve quality. The ISO9000 standard is a great place to start. By design, it allows great flexibility so that it can be applied to a wide variety of operations, from service organizations and retailers to firms that design and build complex devices. You don't necessarily have to become "certified," but by using this standard, you will accomplish several things:
Potential customers may require evidence that you have Quality Management System. This may include an audit by the customer's quality department. An ISO based system will make it easier for the auditors to follow and ultimately make purchases. Any problems that arise will be formally addressed by the Corrective And Preventive Action (CAPA) process.Some customers may list ISO certification as a minimum requirement. If the QMS has been established and supported by top management, ISO certification is not that difficult (compared with starting from no QMS to having a solid ISO QMS).
Decrease uncertainty and increase profits by documenting and improving
your processes. Well documented procedures are essential for smooth operation
and "repeatability" in all business units--not just manufacturing!
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Statistics & Process Control
When management looks at quality data, these types of
questions often arise:
- Is a decrease in failures due to chance or a change in the process?
- Has the solution for a previously solved problem been effective?
- Given today's field failure rate, what can we expect in the future (warranty costs), as products "age?"
- Should sampling or 100% inspection (or neither) be used to determine quality?
These are basic steps to ensure statistical analysis adds value:
- Audit existing data for validity (measuring devices, records, etc.).
- Train personnel in basic statistics and Statistical Process Control (SPC).
- Use field and production failure data to analyze rework, warranty, and customer support costs.
- Use Design of Experiments (DOE) to maximize the efficiency of design
and prototype processes.
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To meet quality system requirements, such as ISO9000 and ISO13485, periodic internal audits are required. Personnel are often "too busy working" to take time to perform a careful audits. Internal political pressures, conflicting goals, and other issues may limit the
effectiveness of the audits that are done.
An independent audit by an "outsider" can provide management with more objective information. Please contact me to discuss details of audit needed.
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Supplier (or vendor) quality has a huge affect on the profit margin. Ensuring a consistent supply of basic "off the shelf" components and materials is no trivial matter. When the role of a supplier is expanded to fabrication of circuit boards, machined components, and ultimately, "turnkey" productuction, potential quality problems rise exponentially. Here are some symptoms of an out of control supply chain:
- Parts not delivered on-time, causing a rush to meet delivery committments to the customer.
- Parts don't match all specifications (e.g., AC switch not from an approved manufacturer).
- Yields vary from batch to batch, requiring more inspection, rework, and parts returned to vendors. This makes production planning very difficult and ties up resources in expediting substandard parts.
- Suppliers provide high quality first articles but routine shipments seem to be built by a whole different process that doesn't match first article quality.
- A turnkey manufacturer can't seem to get the product built correctly. Processes that seemed solid in-house now require "hand holding" to complete at the contract manufacturer. This is often due to deficiencies in the documentation and specs provided to the contractor. When the build was done in-house, "tribal knowledge" filled in the gaps.
The first step is forming a positive, partnership with the suppliers. You may have drop some suppliers. World class quality suppliers may charge a bit more, but over the long term you will make up for this by reduced costs for inspection warranty failures. Work with suppliers to reduce variation by:
- finding mutually acceptable quality criteria. The goal is continuous improvement, with the ultimate goal of "dock to stock" status, where no receiving inspection or tests are required.
- developing a better understanding of each others' processes and improvement plans.
- verifying and validating the documentation provided to the vendor.