Posts Tagged ‘Business Consulting’
Finding Outside Help For Your ISO 9001 Quality Management System Development
Business management consulting can offer a variety of assistance on ISO 9001 quality awareness training, system evaluation, documentation writing/review and internal auditor training. One sign of an experienced consultant is someone who actively engages all appropriate levels of personnel in the process. Experience within your marketplace, specific standard knowledge and the right “chemistry” are other considerations. Using a consultant will increase your cost. However, the guidance and experience of the consultant may reduce the time it takes for you to achieve your ISO 9001 certification.
Registrars are not allowed to consult. They cannot advise you on how to solve a problem. They do highlight where problems exist. The strict separation of auditing and consulting is a fundamental ethical requirement of all ISO 9001 Registrars. Selecting the right Registrar for your situation is critical. Cutting corners at this stage could jeopardize your entire quality initiative. You need to find a Registrar that will work with you as a partner, take the time to learn your organization’s needs within the context of your ISO 9001 effort and reflect your passion for quality.
Product Quality Risk And The Supply Chain
Product Quality Risk in a supply chain focuses on the quality problems in the supply chain context, rather in the manufacturing quality context.
Inherent quality problems such as. raw materials, ingredients, production, logistics, and packaging, in any of the supply chain members trigger a domino effect that spread through a multi-tier supply network. For this reason, it is hard for a network member to keep track of who did what, and when, to the final quality of the products. The product that a company sells to the consumer comprises components made by the company and its suppliers. When the product breaks down due to defects in either the company’s component or the supplier’s component, the company will have to bear the consequences.
Thus, Product Quality Risk is part of the supply chain risks. In other words, Product Quality Risk tend to comprise some or all the risk elements, such as operational risk, disruption risk, reputational risk.
For many small business owners this process can be painful and hard to implement. There are many quality management consulting firms available to help ease the pain by providing sound programs that will accomplish your risk management objectives.
The ISO Standard Says That Internal Audits Cannot be Completed by Someone Involved in the Activity. How Does a Small Business Meet This Requirement?
An organization that has fewer resources must look to other options, like outsourcing or cross-functional activities, to fulfill internal requirements for audit. There are many individuals and organizations that provide internal audit services to small companies at a fraction of the cost of employing personnel full time. The contracted individual or organization manages the planning process for internal audit based on your established procedures or you can develop the plans for ongoing internal audit. Another option is to train individuals within your organization that can perform internal audits and alternate audit activities between processes. For small companies this is often not possible as people are actively involved in all the processes and activities of the company; therefore, outsourcing is a better option to ensure objectivity.
What Is The Role Of ISO 9001?
The objective of any standard, whether it relates to the manufacture of cars, airplanes, machinery, or the delivery of a service – transportation, hospitals, etc. – is the same. Standards are designed to promote, facilitate and enable consistency in a process or product; to provide assurance that the process or product output will meet requirements; to provide a uniform and predictable output every time a set of procedures are executed. Because standards assist buyers and consumers in establishing confidence levels in the products and services they procure, standards facilitate fair trade practices.
Without satisfied customers, an organization’s future is at risk! To keep customers satisfied, the organization needs to meet and/or exceed their requirements. The ISO 9001 standard provides a universally recognized, tried and tested framework for taking a systematic approach to managing the organization’s processes, so that they consistently turn out product that satisfies customers’ expectation.
So, who shall survive the resent economic down turn, and who will succumb to it? Small businesses are in a unique situation to position themselves for the future. Obtaining certification need not be a costly time consuming process. There are many business consulting firms available today that are uniquely equipped to provide the newest and lest expense tools and guidance to help an organization of any size obtain certification. So if you believe that ISO 9001 is something that can help your company meet the changes of today’s world, you don’t need to spend hundreds of thousands of dollars to get there, and don’t let anyone tell you that you do.
How to ensure an effective ISO 9001 implementation
1. The requirements of the standard need to be understood; this may mean sending key employees to an ISO lead auditor course or general ISO training.
2. The company should define its own management system; this may require guidance from a business consulting firm.
3. After a business management system is defined, the company needs to own and defend its management system; this means it is okay to question and analyze conflicting information from outside parties.
4. It needs to be understood that the ISO 9001 system is in place to help a company continually improve. If valid nonconformance is found in a quality management system (verified by analysis), this opportunity should be embraced to improve processes. Processes should be improved in such a way that does not just fix the immediate problem, but really identifies the root cause and initiates effective corrective action to the process.
AS9100C and Risk Management
This new AS9100 certification standard, AS 9100C, involves implementation of a risk management process throughout product realization (product life-cycle).
The stated requirement for risk management within the current version of AS9100B is to understand risk during review of requirements related to the product during contracting activities. Risk management, to some extent, has always been at least inferred by QMSs through planning and preventive action processes. The new risk management clause requires organizations to establish a process for managing risks to achieving customer,statutory and regulatory requirements.
The process should consider: assignment of responsibilities for risk management;criteria for risk acceptance; identification, assessment and communication of risk; and identification, implementation and management of actions to mitigate risk.
There are many business consulting firms that can assist you with how to determine your risks and then prioritize them to better safeguard your companies interests and the community at large.
AS9100 Managing Suppliers
Managing suppliers throughout the aerospace supply chain is a major challenge for the industry. The chain is long, and within the supply base, there are sources that serve many industries. Because the industry is so dependent upon this supply chain, AS9100 includes a number of additional expectations for identifying and maintaining suppliers. Supplier approval is just one step in the process of managing suppliers.
Effectively communicating requirements is very important. The standard lists seven specific areas for consideration. They range from defining engineering requirements to managing test samples and right of access to suppliers’ facilities.
The industry typically relies upon one of three methods for product acceptance. An organization might conduct a receiving inspection, perform the inspection at the supplier’s facility or formally assign product acceptance to the supplier. Procedures for determining the method of supplier control are required, as are the processes used when using these methods.
But no element of supplier control is more important than understanding that a supplier is responsible for managing its suppliers and subtier suppliers. This includes performing special processes that are frequently subcontracted to business consutling firms. The supplier must use customer-approved sources; however, ensuring that the processing is properly performed is the supplier’s responsibility.
A new avenue has opened up in supplier surveillance auditing, which has had the effect of lowering cost and delivering real time results to customers. AS9100 software applications have made it possible to manage the quality requirements for as9100 from your desk top, while lowering the cost of visiting suppliers less frequently. This system is so effective that some registrars are now considering using it for such requirements as document review, corrective and preventive action effectiveness, quality objective review, internal audit effectiveness etc. All of this is done remotely thus lowering travel costs and disruptions to the customer business. Some requirements will always require on site visits, but the amount of time needed to complete a surveillance audit will reduce dramatically.
Documenting A Business Management System: The Required Procedures
The six required procedures, (which can now be combined into four documents in ISO 9001:2008), that need to be written are:
1. How the company controls its documents
2. How the company controls its records
3. How it processes nonconforming product
4. How it conducts and records internal audits
5. How it processes corrective actions
6. How it processes preventive actions
The standard does not dictate how to do any of these processes; it simply provides guidelines and states that a company must document how it performs these processes. A company should not document processes or required procedures based on perceptions of the standard or what an auditor looks for. A company must document its management system based on how it conducts business.
Any other work instructions—flow charts or procedures that a company feels it needs to effectively produce the given product or service—should be done in a format that best suits the purpose controlling these processes. The most important part of documenting any type of process—management process or product process—is to define the inputs, outputs and measurements of the process. The better a company defines how to measure each process, the easier it will be to monitor the outputs (data) and pin point the areas that require improvement.
Why do some companies get discouraged when implementing a management system?
Some of the horror stories about ISO 9001 certification include companies that have binders of procedures, work instruction and forms and have been trying to implement ISO 9001 unsuccessfully for years. Some have spent $50,000 and others more than $200,000 on internal resources and/or consultants. Some have had a prior quality manager who wrote a management system and then left the company, and no other employee knew how to continue the management system requirements. Some have gone through three quality managers, each defining, adding to the last quality management system or adding confusion by changing requirements.
In many instances, companies that have invested considerable time and money in the process of certification have a hard time letting go of it even when it has proven not to be effective or useful. A company must decide if it wants to chase bad money with good money when faced with this problem. It must consider letting the existing management system go and documenting a new and effective management system from scratch. An important part of the ISO 9001 standard is preventing recurrence of a problem. Therefore, it is simple common sense to change or improve a management system and the associated philosophy when the management system is found ineffective.
The benefits of ISO 9001 when implemented correctly
The main purpose of implementing an ISO 9001 system is to improve a process, eliminate waste, save money and ensure that the company will be a contender in future markets. Every process in a company should have a measurement that shows if it is effective and/or met the desired result (the plan). The best platform to improve a process is when the quality policy and measurable objectives are defined clearly, and communicated clearly throughout an organization.
In many instances, a company will not be able to find a way to measure the effectiveness of a certain process or understand how it feeds into overall goals and objectives. In these instances one must further investigate what is the purpose of this process and if it should be eliminated or modified to satisfy the company’s objectives—the why and what if questions.
Some business process reengineering steps are extremely difficult to measure and define, such as a process required to meet a safety requirement, regulatory requirement or customer requirement. It also is important to include the performance indicators of processes so that when an action is taken (corrective or preventive) the effectiveness of those actions can be measured. The most effective method to measure effectiveness is to measure and track costs. This includes cost of nonconformity so when problems are corrected and processes improved, cost savings can be measured.