Archive for the ‘Software’ Category
ISO 9001:2008 Section 4.2.3 Control of Documents (Software)
Documents required by the quality management system are controlled. Records required by the quality management system are controlled according to the requirements given in 4.2.4. A documented procedure is established to define the controls needed:
- to approve documents for adequacy prior to issue,
- to review and update as necessary and re-approve documents,
- to ensure that changes and the current revision status of documents are identified,
- to ensure that relevant versions of applicable documents are available at points of use,
- to ensure that documents remain legible and readily identifiable,
- to ensure that documents of external origin determined by the organization to be necessary for the planning and operation of the quality management system are identified and their distribution controlled, and
- to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.
A basis of the quality management system is the control of documents. Document control is an essential preventive measure ensuring that only approved, current documentation is used throughout the organization. Unintentional use of obsolete documents can have significant negative consequences on quality, costs and customer satisfaction.
“For those responsible for managing their organization’s quality system it is best to design a document control process that is simple to use, easy to monitor and effective to prevent the use of obsolete documentation.” There are many ways to comply with section 4.2.3 of the ISO 9001 standard, and nowhere in the standard does it say how, so it is completely up to the organization to decide which method they will use. Most common methods include hiring dedicated staff, detailed procedures and specialized quality management software programs.
ISO 9001: Where applicable, provide training or take other actions to achieve the necessary competence (Section 6.2.2 b and c)
It is up to the organization to determine the appropriate method to satisfy this quality management system requirement. This can be in the form of on-the-job, job shadowing, mentoring, public seminars, educational courses or any other suitable method.
Follow-up to ensure the competency was effective
Following the training, a suitable evaluation of the employee’s competency level should be completed. The standard requires the organization to:
Evaluate the effectiveness of the actions taken (ref. 6.2.2 c)
Again, the organization must determine the method that works best for their particular needs, ISO 9001 does not specify the how, just the what of the requirement. Verification of effectiveness could be as simple as repeating the competency rating process to ensure the gap has been closed. Other approaches might include:
- Special inspection of the employee’s work until the needed quality level is reached
- Written test following the training
- Formal certification process
- Supervisor follow-up 60 days (or so) following the training or intervention
- Formal performance review
ISO 9001: Determine the necessary competence for personnel performing work affecting conformity to product requirements (Section 6.2.2 a)
There are two excellent reasons to train employees to your quality management system and your processes:
• Every employee can have potential impacts on the QMS; and
• It is a requirement of ISO 9001:2008 and virtually any well functioning quality system
Each person and function within your facility plays a critical role in the quality management system. For this reason, your training program should cast a wide net. Every employee and manager should be aware of the quality policy; the significant impacts of their work activities, key quality roles and responsibilities, procedures that apply to their work, and the importance of conformance with ISO 9001 requirements. Employees should understand the potential consequences of not following the requirements of the QMS (such as poor product performance, reduced customer satisfaction, and loss of business).
All personnel should receive appropriate training and support to be competent at their work.
Training should be tailored to the different needs of various levels or functions in the facility. However, training is just one element of establishing competence, which is typically based on a combination of education, training, and experience. You should establish criteria to measure the competence of individuals performing tasks that can impact on the quality of your products.
Training is needed both in technical work and for general awareness on the part of all employees
To define requirements for each job position questions to ask:
- “What job-specific knowledge area(s) must be well understood by someone in this job?”
- “What manual, mental or interpersonal skills must an employee have to do this job well?”
- “What natural abilities or talents must someone possess to be effective in this job?”
The result from this exercise is a list of competencies for the job that can be used for hiring purposes and subsequent training and development plans. Once the list is prioritized to include only the most critical competencies, you will need to document them in some appropriate manner (job descriptions, training matrix, or other means).
What Are The Inputs and Outputs and Key Measurables Of A Process?
With ever business process that you put in place there are inherent inputs, outputs and key measurable that will help you determine whether or not you are meeting the objectives of the process. You will first need to determine the inputs of your processes, “What are the key aspects of the process that you would like to achieve?” For instance, in your supplier management process what will be your objective? Your objective should be to have approved suppliers. Now, what will you put in place to achieve your objective: Supplier approval criteria, Supplier Evaluation (inspection discrepancies) and Supplier Reevaluation. These will become the inputs to your supplier management process.
Once you have determined the inputs of your process you will next need to determine the outputs of the process. In the example noted above some possible outputs to the supplier management process would be an Approved Supplier Register, and Receiving Discrepancies. These will become the evidence of your approval process objectives.
Once you have determined the inputs and outputs of your process, you must now measure the process to see if it is accomplishing its intended purpose (Approved Suppliers based on the inputs and outputs you have set in place). Key measurable for a supplier management process may include Supplier Performance data reviewed in Management Review (Receiving Inspections), Evidence of the organizations certification to an international standard (A copy of a current ISO 9001 or AS9100 certificate), results from a supplier audit or survey , etc. You must determine how you will measure a supplier’s performance towards your requirements and then keep records to verify their effectiveness at meeting these requirements.
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 Customer Satisfaction How Do I Measure This?
ISO 9001:2008 requires that customer satisfaction is monitored but does not specify methods. You must decide how to satisfy this requirement in a way that makes since to your organization. What can you measure that will improve your customer satisfaction ratings and add value to your organization at the same time. Some measures you may consider are as follows:
1. Do you deliver on time?
2. Do you deliver in full?
3. What feedback do you get from sales or service engineers?
4. Are the key accounts growing?
5. Customer audits or report cards? If favourable, use them as evidence of customer satisfaction.
6. Direct feedback from the customer both positive and negative, track them. If enough customers are saying the same things about your company, you may want to put some measurement in place to resolve these issues. If they are saying something wonderful about you, make this a priority to provide this service to all your customers.
Remember, you are in business to grow and the best way to do this is to satisfy your customers. Focus on measurements that will result in setting you apart from your competition. Don’t give lip service to customer satisfaction because you will suffer a finding during your surveillance audit because you cannot produce evidence that you even know what your customers think of your performance. If you have a hard time determining what you should be measuring and analyzing, ask your customers what is important to them.
ISO 9001 Documentation
As a third party auditor, I have seen so many examples of how not to document your quality management system. Most of the mistakes stem from lack of understanding of what the standard really does require. So many times I see companies who have paid someone to come in and document “their” system and nine out of ten times the system is either too complicated or does not reflect what they actually do. A full 90% of the non-conformances which are discovered during a surveillance audit have nothing to do with meeting the requirements of the standard, but are written against the requirements the company has imposed on themselves.
I’m here to tell you it doesn’t have to be so hard to meet the requirements of ISO 9001:2008 and manage your quality management system documentation. Hiring an outside consultant can be a great experience when the consultant facilitates the activities involved in developing your quality system, but leaves the ownership and management of the system to you. This is your system, not the consultants, and should be developed and implemented by your organization so it reflects the actual practices, processes and documentation of your organization.
There are only six required documented procedures and a quality manual that you “have to have “ , all other procedures that you develop are up to you. Don’t add procedures that do not add value to your processes. If you need a procedure to complete a process properly or a customer has required it of you, then you must have that procedure. If you want to have procedures for training purposes only, then call them just that. The key is to keep it simple and manageable, you’re in business to make a profit, not manage a monstrous quality management system. If you are not sure how to go about tackling ISO 9001 certification, call a reputable consultant, they can help set you on the right path. In the end, it is your system, and it should reflect what you do in a way that is transparent and easy to maintain.
Finding an ISO 9001 Auditor that fits the needs of your company
Finding an ISO auditor that fits well with your company is fundamental to a successful certification experience. You want to work with a person that you are comfortable with and that is comfortable with you! Here are some tips that you can follow to find an auditor that you know you will work well with your company:
Try to find a registrar that has somebody who can answer your questions, someone that you feel comfortable with and meets your financial requirements. Make sure the registrar has auditors with experience in your area. What good is a registrar that has an auditor that lives down the street from you if they’ve only audited service processes? They’ve never audited a machine shop, and you’re a machine shop.
You want an auditor that fits you and your company and gives you good observations and opportunities for improvement as they audit. Ask to talk with your potential auditor. It’s always nice to be able to converse with somebody so you get to know who they are before you meet them. If they are in the area, maybe they can drop in just to talk to you, just to put a face to the name.
Some registrars have auditors all over the United States and even some overseas. Be careful when you are trying to find an auditor close to you. Sometimes you are going to find that the auditor you like isn’t close to you. If you like that person, and are willing to pay travel expenses, the registrar should be happy to send that person to you.
Remember you are the customer, make sure you exercise your right to selecting the auditor that best fits your needs.
ISO 9001 Why Struggle?
Does this sound familiar to you? We have been trying to get certified to ISO 9001 for years. Quality managers come and go, and with them goes all of the process we have made. Once they are gone, no one understands the systems they have started and we are back to square one again.
I am here to tell you it doesn’t have to be that way.
ISO 9001 is not that hard to implement, but so many companies make it that way. Why you may ask is this so? It is a question of understanding the requirements and how to implement them so that the quality system you establish belongs to everyone in the company. If everyone is involved, then the next time your point person leaves the company, the system will not fall apart. Your quality system should be transparent to your day to day activities and processes, just as breathing is to you. It should happen because that’s just the way you do things , period.
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.