Posts Tagged ‘AS 9100 Software’
Quality Management Systems Software Advantage
With all of the software packages out there today, it is hard to believe that there are any companies who still design their quality systems on paper. I grew up on the manual paper version of a quality management system, back when there was a whole department dedicated to document control and everyone had a three ring binder full of documented procedures on their desk. So here we are today with ISO 9001:2008, AS 9100 C and various other international standards which do not require reams of paper to be compliant. When a company decides to implement a new quality management system, I don’t believe anyone sets out to create the quality system from hell, but all too often that is exactly what happens.
Why put yourself through all of that pain and unnecessary cost? There are so many software solutions available today that make getting and maintaining your certification effortless. As a management representative for a small company in Arizona, I was able to manage the quality system and carry out the responsibilities of a supply chain manager without adding one more person to the company for the sake of our quality system. How you may ask is this possible? The answer is a fully customizable software application that put all of our processes and documentation in one place. This software is SaaS based and therefore it is accessible from anywhere internet access is provided. All of our employees, key customers and suppliers were able to view and make entries as need and management decisions where determined through the analysis of the data collected by the system. What was most impressive about the implementation process was how easy it was to train everyone to use the system.
As I said before there are literally thousands of software applications for quality management system implementation. The range of products goes from supper high upfront and maintenance costs, to low upfront and maintenance costs. Complicated canned systems with little customization possibilities to easy fully customizable systems are also available. If your company is use to complicated and costly to believe you are getting a good product, then that’s the road for you. If on the other hand you are a small to midsize company with limited resources, (People and Finances), you may be interested in the latter. Do your research well and you can find a system that will work for you and actually deliver a cost savings benefit. Some items to consider:
Costs
- Upfront Cost
- Monthly Support Costs: or
- Yearly Support Costs:
- Does your system include Unlimited Users and Storage and support and revisions and new features.
- Education & Safety Costs
- Cost for Additional Modules
Applications
- Communication System
- Document Management
- Reports and Graphs
- Master Calendar
- Work Orders
- User Preferences
- Nonconformance
- Corrective Action
- Customer Feedback
- Preventive Action
- Near Miss
- Customer Supplied Product
- Inspection
- Management Review
- Internal Audits
- Calibration Control
- Quality Objectives
- Supplier Approval and Evaluation
- Competency, Training and Awareness
- Purchasing
- Job Management
- Special requirements
ISO 9001/AS9100 Who Owns Your System?
ISO 9001:2008 requires top management to actively participate in their organization’s quality management system by developing and implementing quality objectives and periodically evaluating the health of the system. This concept may seam foreign to some top managers, as some organizations still subscribe to the notion that the management of their quality system belong to the quality manager. As a lead quality management systems auditor I have seen this time and time again, often with bad news for those at the top. Without the ongoing participation and commitment from top management, it is virtually impossible to maintain a quality system that consistently meets the ISO 9001 standard or any other standard for that matter.
Top management must be involved at all stages of the quality system, from planning to implementation and ongoing maintenance. Some key areas where management should be involved are as follows:
- Setting Quality policies, planning, and objectives
- Appointing a Management representative and giving them the authority to fulfill their job responsibilities.
- Conducting Management Reviews that involve all of the required inputs and outputs of the QMS and making decisions that will promote continuous improvement.
- Enlisting and Utilizing customer feedback to meet customer satisfaction requirements
- Being visibly involved so that employees know that this is a business management system that is being driven from the top down.
What is most important is that “everyone” is involved with your quality management system, and realizing that no one person in the organization owns it, “everyone” owns it. Everyone must do their part, or as sure as I’m sitting here, the quality system will never deliver the results that is expected. When I hear someone say that ISO 9001 is just another expense, (No Benefit), to be endured for the sake of the customer, I know that these companies do not understand the overall commitment, (Involvement), required to receive any benefit. What type of company do you work for?
ISO 9001/AS9100, Why Do I Have To Conduct A Management Review?
Just as a person should have periodic physical exams, your QMS must be reviewed periodically to stay “healthy.” Management reviews are critical to continual improvement and ensure that the quality management system will continue to meet your facility’s needs over time.
The ISO 9001 standard states, the purpose of a management review is to review the Quality Management System to ensure its continuing adequacy, suitability and effectiveness. This should include an evaluation of the performance of the system based on existing data (review inputs), and should also address any decisions or actions necessary to improve the management system and its related processes (review outputs).
To make your reviews meaningful, such reviews should be performed at least annually, although they may be performed on a more frequent basis, including quarterly or even monthly. The frequency of these reviews is your choice, but I personally recommend that organizations with “newer” systems perform this function on a more frequent basis, at least for the first 18-24 months.
Records of these reviews should be maintained in accordance with your documented control of record procedures. These records should include, the date of the review, participants in the review, criteria by which the system is measured, (Inputs), strengths and weaknesses of the system, and any decisions or actions that are required (Outputs). Such inputs should include, but are not limited to the following:
- Results of Internal Audits
- Customer feedback, both positive and negative
- Process performance and product conformity
- Status of corrective and preventive actions (Are they closed and are the actions taken effective)
- Follow-up of actions from previous management reviews (Are actions being completed?)
- Any changes that could affect the quality system (Personnel, facility, regulations, business direction etc.)
- Recommendations for improvement
Outputs from this review should include and decisions or actions related to the following:
- Improvement of the effectiveness of the QMS and its processes
- Improvement related to customer requirements
- Resource needs to support the QMS.
Getting The Most Out Of Your Quality Objectives
ISO 9001:2008 mentions quality objectives at least 14 times. Basically, quality objectives allow us to measure our progress and make improvements. How else can we conclude if we’re doing the right things and what we should do next? Without metrics you have no way of knowing if there has been a return on investment for an improvement initiative, capital expenditure, or new product design.
Objectives are the essential links between day-to-day activities and strategic planning. They make it possible for individuals throughout the organization to monitor processes and communicate performance to the decision makers. When we develop our strategic objectives (the ones that will move us to the next level of quality or profitability), what should we be looking at and how should we be looking at it.
The standards for ISO 9001 and AS9100 require that objectives be set and implemented to promote continuous improvement. If you were to set objectives that had no measureable metric and no time line for completing, how would you ever know if you had completed them or if they made any difference at all?
As a third party auditor, I have seen many failed attempts at setting meaningful objectives. The primary reason for these failures is lack of understanding of what should be included when setting these goals.
A good rule of thumb is to always include the following information in each objective:
- A starting point-Where are we now?
- A desired result-where do we want to be and what do we want to accomplish?
- When do we expect to complete this objective-Put a stake in the ground.
Example:
“We will improve our delivery performance to our customers from 85% to 95% by December 2010.”
Once you have set your objective now you must show progress toward completion-measure and report. Make decisions and take action to keep moving in the right direction. If you miss your deadline, don’t worry, you can always push your time-line out. The primary reason for objectives is to keep moving toward improving your quality management system and better satisfying your customers. Competition is steep in today’s economy; keeping ahead of the competition requires planning and measuring on a regular basis. Make your objectives count; they can be the difference between success and failure.
My Customer Wants Us Certified to AS9100, HELP!
You are a small business owner who has just been told you must become certified to AS9100 in order to continue to receive business from your largest customer. You have been putting this off for some time, hoping you would be able to wait until the economy gets better. Now what, you have a deadline and you haven’t got a clue how to get there from here? The best advice, find a competent consultant and get some training to the standard.
Those organizations who recruit good consultants get the job done roughly twice as fast. By helping you avoid mistakes, a good consultant can help you get the job done faster. But only a good consultant can do this. Not all consultants are created equally, and it is important to select a consultant that is right for you. A reputable consultant works hard to ensure that you fully own your quality management system at the time of registration. Key services you will require, if you have no idea what you are doing or how you will do it are as follows:
1. Required documentation development and implementation
2. Training: Quality policy and objectives, Management review, Corrective and Preventive action, Internal auditing, AS9100 Overview, Risk analysis, Overview of the Complete QMS, Collecting and analyzing data.
3. If software is being used to facilitate and run your quality system, you will also need training and implementation services for this.
4. Implementation of a competency, awareness and training program, internal audit, corrective and preventive action programs, management review and overall continual improvement programs.
5. Conduct internal audits for entire system (all processes), one high level internal audit to the AS9101C checklist in preparation for registration audit.
This is just a short list of services that you may need to accomplish your goal of certification to AS9100. Depending on the size and complexity of your organization and processes more may be needed. A good consultant can help you determine your individual needs.
Time Saving, Money Saving ISO 9001, AS 9100 Alternatives
There are now products and services available that make it possible to work together with one or more of your staff online to create and write or revise the necessary procedures that are required by an ISO 9001 or AS 9100 system. Your staff can be at different locations or even at their own desks within your company. There is no need to meet in a conference room, since the conference room is virtual (on the Internet). This approach reduces costs dramatically and results in a better and more efficient working relationship.
First, this technology makes it possible to work at your pace and at your schedule to meet the project’s deadline;
Second, there are no flight, hotel or meal costs! Huge cost reduction;
Third, you can work with your ISO consultant and multiple managers at your facility or at your facilities across the nation in one meeting;
Training is the most important feature of any management system. The better trained the better performance you can expect from your staff. This technology can also make it possible for your ISO 9001 consultant to provide training online to one or many of your employees at the same time. This training can be at your schedule and because the training is performed online, there is no travel, hotel or other expenses.
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.
Quality Management Software
With the size and complexity of some supply chains, it is no wonder that organizations struggle with how to implement and control this process. Many small business owners have been asked to provide proof of this control by their customers. The question is, how?
If you are struggling with how to manage your supplier management program there are now software applications that can assist you with this task. For example, CIS Software can eliminate the time and money of issuing Supplier Report cards or Performance Reviews. Watch this YouTube video for some great information on how to better manage this process. CIS Software
AS9100 CLAUSE 6.3 INFRASTRUCTURE
Essence of the clause:
Your company must determine and your business management system must provide for and maintain the infrastructure needed to produce a quality product or service.
Who’s most involved: Management (of almost every department)
Buildings, workspace, equipment, hardware, software, and supporting services must be provided to the extent necessary to produce a quality product or service. These facilities must also be maintained, usually through a preventive maintenance program. (See Clause 7.5.1)
The Goal Of The AS9101 Rewrite
The AS9101 rewrite goal is to provide requirements on process auditing and development of AS9100 series audit approaches and tools that focus not only on conformity, but also on effectiveness of a AS9100 quality management system (QMS). The AS9101 proposal is to develop an enhanced audit process for evaluating process-based management systems that aligns with ISO 17021 and consists of:
• Process-based information gathering.
• Assessment or analysis and audit planning.
• Development of performance-based and process-oriented audit methods and techniques.
• The ability to capture objective evidence of process conformity and effectiveness.
The major proposed changes in the rewrite of AS9101 include:
• Creation of one document covering AS9100, AS9110 and AS9120.
• Elimination of scoring and key requirements designations.
• Use of data and customer feedback concerning organizational QMS performance as an input for process-oriented audits (for example, Online Aerospace Supplier Information System (OASIS) customer satisfaction or performance scores).
• Inclusion of determination of effectiveness, in addition to conformity.
• More emphasis on performance measuring.
• Introduction of the objective evidence record.
A major theme of the AS9101 rewrite is examining process effectiveness. ISO 9000:2005 defines effectiveness as the extent to which planned activities are realized and planned results achieved. The ultimate measure of QMS effectiveness is customer satisfaction.
What has not changed in AS9101 includes determining conformity to the standards, documenting discovered nonconformities and drawing conclusions on conformity of the organization’s QMS based on information collected during the audit.