Posts Tagged ‘as9100 software’
ISO 9001 Internal Auditing Success
The third party auditor will audit your system once or twice a year, so why do you have to conduct internal audits? The first and most obvious reason is, if you wait for the third party auditor to tell you your system is in trouble, you are missing the point of continuous improvement all together. The second reason is that the third party registrar does not consider the surveillance audit as an internal audit. The standard requires that “you” perform planned internal audits of your system based on status and importance of the processes and areas to be audited. If you do not know whether or not your quality management system conforms to your planned arrangements, or the standard, then how can you determine if you are improving? The ISO 9001 standard is based on the Plan, Do, Check, Act principle of continuous improvement. Internal Auditing is the “Check”, and without it you may never know when to act.
The internal audit process need not be a time consuming; there are many ways an internal audit can be accomplished. Every day we conduct countless audits without even knowing it. A manager who walks the plant floor may notice a process which is not working as intended, a worker may notice that the forms he, or she is using are outdated , receiving may find that the same supplier never send the correct paperwork with the products they provide; these are audits that never get documented. These audits are not planned, but they are audits none the less. The planned audits do not have to include all of the processes in your facility once a year, remember “Status and importance”. Go after the low hanging fruit first, (areas where you are having issues), then review the other areas as needed. Whatever you do, DO SOMETHING, or your entire quality system will fail to accomplish the goals and objectives you have set for your organization. My philosophy is simple, if you are going to invest the time and money to become certified, get the full value of certification or you will be wasting your resources for nothing.
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.
If AS9100:2009 is published, why can’t I get certified to AS9100C now?
Before any company can be certified to the AS9100C standard, the aerospace industry must complete these milestones:
- The AS9104-1 standard must be published (expected spring 2010)
- The AS9101D standard (checklist) must be published (expected Spring 2010)
- The AS9100C/AS9101D course for certification body auditors (NQA auditors) must be developed, vetted and made available for use by certification bodies (expected by 30 April 2010)
- Certification body auditors must attend this course, pass it, submit their applications to RABQSA and get approved (we expect that to happen over the summer and fall of 2010)
- The registrars must submit an application to ANAB and then be audited before we can be accredited to perform audits to AS9100C (we expect that to happen early summer of 2010)
Once all of the above tasks are completed, registrars will be able to conduct audits to the quality management system requirements of AS9100 revision C.
As to when your company must transition to this new standard, all AS9100 audits after July 1st, 2011 must be to AS9100C and that by July 1st, 2012, AS9100B will cease to exist and all registrations for AS9100 must be to revision C of the standard.
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
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.
AS9101 C Checklist Why The Revisions?
As part of an AS9100 certification audit, a numerical scoring of the audit results is required. This is defined in the AS9101 checklist document.
An organization’s AS9100 certification status and the scoring results from the certification audit are posted in SAE’s OASIS database. Access to the OASIS database for information on organizations certified to AS9100 is available to the general public. Access to the scoring results is limited to only authorize controlling entities for the Registrar Management Committee.
AS9101, which is mandatory for use during Third-party management audits, is currently being completely rewritten. This AS9101 rewrite will replace the existing version of AS9101 Quality Management Systems Assessment, AS9111 Aerospace Series Quality Management System Assessment for Maintenance Organizations (associated with AS9110) and AS9121 Stockist Distributor Quality System Questionnaire Associated with AS9120. The current versions of these documents drive undesirable results because they inhibit the process approach, focus the auditor on completing the checklist and take time away from actual auditing. In addition, the current versions of the AS9101 series of documents are not in alignment with the newly published AS9100 series of documents and the ISO 17021 stage one and two approach.
AS9100 Root Cause And Corrective Action
Root cause corrective action for nonconformance’s has long been a requirement in theaerospace industry as stated in the AS9100 standard. It is a process of determining the causes that led to a nonconformance or event, and implementing corrective actions to prevent a recurrence of the event. The requirements for corrective action have been imposed on the aerospace industry for decades and while not new, may not have been aggressively enforced.
Corrective action begins with clearly defining the actual problem. While this may seem simple,many recurring nonconformance’s result because the wrong problem was solved, only the result was fixed, or only one problem was corrected when there were really two or more problems. In order to fix a problem, it must be clearly and suitably defined. Frequently, the nonconformance identified is not really the problem, but the symptom of the problem.
The best ways to arrive at the true root cause of a nonconformance is collect and analyze data that will support your conclusions. There are many tools and methods to collect data that can aid in problem identification. Among these tools are software solutions which can collect and graph information for ease of analysis. AS9100 software applications can help your organization clearly and accurately identify the root cause of a problem, so that you can implement corrective action that will resolve and prevent the problem from reoccurring in the future.
True Value-Quality Management Software
There are many business management software packages out there today. Many of these packages promise a lot but deliver little. Once you’re in, the cost to operate and maintain the system grows exponentially. This is fine for large companies who almost expect something to cost a lot of money for it to be worth using, but let’s face it, how many small business owners can really afford this. If perceived worth is judged by how much or little someone pays for a product, it would seem that the only companies that get great value are the ones with deep pockets.
I suggest that the true value of anything we purchase, is the overall cost, actual benefit and ease of use over the long haul that makes a product truly valuable. For example we have two companies, both have approximately fifty employees. They have selected two software products as possible solutions for their management system needs.
Software product No.1 offers the following:
- Upfront Cost: $ 5,000.00 (ALL MODULES)
- Monthly Support: $ 385.00, OR
- Yearly Support: $ 4,620.00 (for comparison purposes)
- Unlimited Users and Storage and support including revisions and new features.
- Upfront Cost = $ 5,000.00
- Cost over 5-Years: $ 28,100.00
Software product No.2 offers the following:
Core Tool Kit includes: Non-Conformances | Corrective/Preventative Actions | Document Control | Tooling & Equipment Maintenance | Customer Service | MOPS (Trend Analysis) | Key Indicators Dashboard
- Cost for Core Tool Kit: $ 5,000.00 for First User
- Each Additional User: $ 1,500.00/User (49 required)
- Cost for Additional Modules:
- Auditing: $1,500.00
- Education & Safety: $1,500.00
- Health & Safety: $1,500.00
- Web-Based Surveys: $1,500.00
- Inspection: $2,500.00
- Annual Maintenance Fee: 18% of Total Cost including users fees
- Yearly Maintenance( 18% of Total): $ 15,660.00
- Upfront Cost = $ 87,000.00
- Cost over 5-Years: $ 165,300.00 (training not included)
Both software applications offer similar capabilities, but the up front and ongoing costs are light years apart. Both companies have proven track records for achieving certification to international standards such as AS9100 and ISO 9001. Now, you tell me where is the true value?
Preventive Action “What If”?
Many organizations struggle with how to determine what constitutes a preventive action. To determine what should trigger a Preventive Action investigation, ask the question “What If”.
- What if weI only have one piece of equipment?
- What If we only have one set of tools for a critical process?
- What if we only have one person with the skills to do a certain process?
- What if one of our key suppliers goes out of business or is destroyed by a natural disaster?
Any of these criteria may point you to a potential opportunity for a preventive action. When investigating a preventive action it is important to identify all the risks and costs of having the problem and weigh it against the likelihood of it happening. The benefit to the process and or company if you were to implement the improvement and the legal and ethical reasons for implementing the action regardless of the cost or potential benefit should always be considered prior to implementation. ISO 9001 software and as9100 software packages can aid you in collecting and evalateing this information you gateher from this prcess.
The Calibration Conumdrum
All Quality management system standards uniformly have requirements for controlling the equipment and devices used to measure, verify, test, and accept product and monitor the processes used to achieve specified results. As a third party auditor it seems like almost everyone misses something. It’s almost unavoidable. Clearly it’s because this process is generally referred to as “calibration” and the mental image it invokes is associated primarily with things like micrometers, depth gages, and comparators. The process is often much more complicated, addressing appropriate consideration for gages, thermostats, software, jigs, timers, CMM’s etc. Controlling monitoring and measuring devices must, therefore, include multiple aspects.
What are some of the features of a good calibration management process?
- Identifying equipment
- Defining frequencies
- Indicating status of equipment
- Alternate methods of “control”
- What to include in the procedure
- Certificates of calibration
- Outsourcing calibration services
- Storage and preservation
- Recall programs and contingency plans
Whether implemented manually or electronically, calibration control is crucial for a management systems success. There are as9100 software calibration systems designed to manage and simplify control of calibration requirements including repair, maintenance and recall. Some may also manage tests/inspections that must be done on a periodic basis such as a monthly inspection. When determining whether your system will be manual or electronic, it is always wise to first know your own capabilities, manpower, and processes. Do you know where your system stands?