Posts Tagged ‘business processes’
Your Internal Auditing Process, Does It Hurt Or Help Continuous Improvement?
A Quality audit is the process of organized inspection of a quality management system carried out by an internal or external quality auditor or an audit team. It is an important part of organization’s quality management system and is a key element in the ISO quality system standard, ISO 9001.
Quality audits are typically performed at predefined time intervals and ensure that the institution has clearly-defined internal quality monitoring procedures linked to effective corrective and preventive actions. This can help determine if the organization complies with the defined quality system processes and can involve procedural or results-based assessment criteria.
With the upgrade of the ISO9000 series of standards from the 1994 to 2008 series, the focus of the audits has shifted from purely procedural adherence towards a process approach of the actual effectiveness of the Quality Management System and the results that have been achieved through the implementation of a QMS.
Audits are an essential management tool to be used for verifying objective evidence of processes, to assess how successfully processes have been implemented, for judging the effectiveness of achieving any defined objectives, to provide evidence concerning reduction and elimination of problem areas. For the benefit of the organization, quality auditing should not only report non-conformances and corrective actions, but also highlight areas of good practice. In this way other departments may share information and amend their working practices as a result, also contributing to continual improvement.
Internal audits should always be performed with the intension of improving the overall systems being audited, never as a fault finding or witch hunt practice designed to punish. If internal audits are properly executed with a spirit of open communication and real process improvement, this process can be the single most important driver for continual improvement. Done wrong, the internal quality audit processes can create a culture of fear which will hinder continual improvement. It is important that everyone within the organization clearly understands the objectives of quality auditing and their role in them.
Does Your Corrective Action Process Really Work?
When a deficiency in your quality management system is discovered, is it documented and thought of as a good thing? One of the most common problems I have encountered as a third party auditor and consultant is the fear of Nonconformance’s. During initial presentations to a company, particularly if I have senior management in the room, I will ask about their corrective action process, how it’s working for them and how many nonconformance’s they document in an average month. A typical answer is a very proud indication that they have a great corrective action system and they generate very few nonconformances. That is a self-contradicting statement.
Chances are very good that nonconformances are seen as a bad thing in these companies and the person responsible for this horrible offense is hunted down and profusely reprimanded for such callous offenses. Does this sound familiar?
Let me set those who still feel that nonconformance’s are bad, THEIR NOT! If you find 3 things going wrong within your organization this week, and resolve them so they never happen again, do you think you have improved your company’s performance? Hello McFly, guess what the bonus is – there’s a pretty good chance you will improve your bottom line as well! So get out there and find as many nonconformances as you can. You have nothing to lose and everything to gain. Remember, the whole idea is to continually improve your products and processes so that you can compete and grow.
ISO 9001 Don’t Survive, Thrive!
Why is it that when times get tuff most companies invest most of their time and money in short term short sited goals? The ultimate goal of any company should be more than just survival; it should be forward thinking total sustained success. How can a company reach for and attain sustained success with the economy in such distress? The best way is to invest in continuous process improvements that result in cost reductions and increased market share.
Becoming certified to the industry standards that your industry leaders are requiring is the surest way to stand out and get noticed. If your competition is already certified to ISO 9001, AS 9100, RC 1400, ISO 1400 or some other industry standard, they have a decided advantage over you and how much more business they will receive as a result of this certification. If you are certified, how well you manage your business processes can help or hurt your progress toward sustained success.
Many companies go after certification to satisfy a customer request or simply because they believe it the right thing to do. However, the majority of the organizations that embark on the road to certification, go into the process ill equip and ill informed. The result of such endeavors usually produces a business management system which may ultimately result in certification, but offers no advantages and becomes just another expense to absorb.
My advice, get educated, hire a competent business management consultant if you fell you need one, and make your business management system your own. Every business is different and so each business management system should be unique as well. Don’t waste hundreds of thousands of dollars and years of consulting fees to reach you goals. Take ownership of your system and make it a transparent part of your everyday work experience. When a well designed business management system is implemented, it is effortless and provides real tangible benefits that result in sustained success. Don’t survive, thrive.
Quality Objectives For ISO 9001
It is the responsiblity of the ISO Auditors tol verify that the organization’s overall quality objectives have been defined, that they reflect the quality policy, are substantially coherent, aligned and compatible with the overall quality management objectives, including customer expectations. If this is not the case, the auditors may further evaluate Top Management commitment to quality.
The fulfilment of quality objectives needs to be measurable and documented.
There is no specified way of identifying or documenting quality objectives, as these may appear through business plans, management review outputs, annual budgets, etc. It is up to the auditors to satisfy themselves that the objectives are adequately documented.
A good rule of thumb when developing quality objectives, is to describe the following:
Example: To improve on time delivery to our customers, from 65% to 95% by December 2010.
- What is the present state of the proposed objective? Where are you now?
- Where do you want to be once you have achieved your objective?
- When do you want to complete the objective? It is o.k. to push the end date out, if it ends up taking longer than anticipated, but you should put a stake in the ground to indicate your commitment to completing them.
Next you will need to show the auditor how you have gotten from point “A” to point “B”. What did you do to achieve your objective? Record all the steps that you took to reach your objective. What is most important is to clearly describe your objective and record progress toward achieving it.
ISO 9001 vs. Six Sigma
Six Sigma is a statistically-based process that strengthens organizational ability for ongoing business process improvement. “Six Sigma” or “six standards of deviation” endeavors to reduce defects to a rate of 3.4 defects per million defect opportunities by identifying and eliminating causes of variation in business processes. In defining defects or errors, Six Sigma focuses on developing a clear understanding of customer requirements and is therefore very customer focused.
ISO 9001 and Six Sigma serve two different purposes. ISO 9001 is a quality management system, while Six Sigma is a strategy and methodology for business performance improvement. ISO 9001, with guidelines for problem solving and decision making, requires a continual improvement process in place but does not indicate what the process should look like. Six Sigma can provide the needed improvement process. However, it does not provide a template for evaluating an organization’s overall quality management efforts whereas ISO 9001 does.
Obstacles to Sustained Success
What makes a company successful? Is it better leaders? Better products? Better salespeople? What about a better business management system? Any of the above may bring some improvement, but most often sustained top performance can be coupled with one thing; how well people communicate within a company.
In particular, sustained success requires a culture in which open and honest dialogue occurs around even the thorniest topics.
This requires focusing on the issues, not playing political games. It also requires determining the potential consequences of all the solutions uncovered.
It doesn’t take a rocket scientist to know that ignoring problems makes them worse, not better. What prevents problems from being dealt with? Leaders who never learned to facilitate conflict; aggressive personalities who use intimidation to maintain the status quo; and apprehensive leaders who focus on maintaining control, instead of doing what’s good for the company.
When open and objective discussion is missing, so is the possibility for sustained success.
Guidance for the Use Of Configuration Management
ISO 10007:2003 gives guidance on the use of configuration management within an organization. It is applicable to the support of products from concept to disposal.
It first outlines the responsibilities and authorities before describing the configuration management process that includes configuration management planning, configuration identification, change control, configuration status accounting and configuration audit.
Since ISO 10007:2003 is a guidance document, it is not intended to be used for certification/registration purposes.
This is a great tool when tackling the concept of configuration management, a lot of emphasis is placed on this process in the AS9100 certification standard. Using this document along with the assistance of a business management consultant, can reduce the time it may take to plan and implement this process.
ISO 9001 The Process Approach
How often have you heard that ISO 9001 promotes the process approach to managing an organization, and requires the QMS to consider the organization as a series of interlinked processes? What does this really mean in laymen’s terms?
Processes can be characterized as consisting of one or more linked activities that require resources and must be managed to achieve predetermined output. The output of one process may directly form the input to the next process and the final product is often the result of a network or system of processes. Every organization is made up of a series of interacting processes.
The process approach considers the interaction between these processes, and the inputs and outputs that tie these processes together. The output of one process becomes the input of another.
The ISO 9001 Standard is designed to manage and improve those processes.
1. First, you identify your key processes.
2. Second, you define quality standards for those processes.
3. Third, you decide how process quality will be measured.
4. Fourth, you document your approach to achieving the desired quality, as determined by your measurements.
5. Fifth, you evaluate your quality and continuously improve.
Once these are identified, an organization can ensure its processes are effective (they produce the desired output), and efficient (they promote continual improvement and lower cost by effective use of resources). The organizations ability to master the techniques of business process improvement, can help the organization gain a distinct advantage over the competition.
Business Process Mapping and Your Quality Mnagement System
Business Process Mapping (BPM) is a method for improving a company’s efficiency and quality. The methodology is applicable to any planned activity.
The increasing simplicity, (downsizing), and accountability of all organizations , including public service and government, together with the modern intricacy, infiltration and importance of computer technology, for even very small business organizations, has tended to heighten demand for business process improvement everywhere. This means that Business Process Mapping is possibly more widely important than say Total Quality Management, an earlier efficiency methodology.
Simply put, Business Process Mapping aims to improve business performance by optimizing the efficiency of connecting activities that result in the product or service an organization provides to its customers.
Business Process Mapping techniques are concerned with ‘mapping’ and ‘workflow’ to enable understanding, analysis and positive change. Diagrams – essentially ‘flow diagrams’ – are a central feature of the tactic.
The flow diagram of a Business Process Map represents the total business process for an organization and how each individual process connects with the next. There are many software applications which exist to enable this, but the basic principles of Business Process Mapping can also be applied using a pen and a dinner-napkin or a flip-chart or sticky notes, and in some cases these are still brilliant aids for creating and communicating basic ideas. So choose your methods wisely. Business Process Mapping generally needs support from people to work successfully no matter the methods used.
Common Misconceptions of Preventive Action
Corrective Action Preventive Action (CAPA) is a concept within Good Manufacturing Practice (GMP). CAPA focuses on the systematic investigation of discrepancies (failures and/or deviations) in an attempt to prevent their recurrence (for corrective action) or prevent from occurrence (for preventive action). To ensure that corrective and preventive actions are effective, the systematic investigation of the failure incidence is pivotal in identifying the corrective and preventive actions undertaken. CAPA is part of the overall quality management system (QMS).
A common misconception is that preventive action is to avert the occurrence of a similar potential problem. This process is all part of corrective action, because it is a process of determining such similarities that should take place in the event of a discrepancy.
Preventive action is any proactive methodology used to determine potential discrepancies before they occur and to ensure that they do not happen (thereby including, for example, preventive maintenance, management review or other common forms of risk aversion). Corrective and Preventive Actions both include investigation, action, review, and further action if so required. It can be seen that both fit into the Plan Do Check Act philosophy as determined by the Deming – Shewhart cycle.
Increasingly these days, the aerospace industry is driving it’s suppliers to perform better and better. By continuously focusing on prevention and jumping on correction, some companies are rising to the top and securing larger portions of the business. Your CIS software consultant can help you achieve your goals and satisfy your as9100 auditing requirements. This as9100 software will blow your competition out of the sky.