Posts Tagged ‘opportunities for improvement’
Documenting a management system: The Manual
The first step in implementing an ISO 9001 system is to document a quality management system. The required documentation is a quality manual that could be called a business systems manual because it covers the scope of the entire business, not just the quality aspects. There also are six required procedures (control of documents; control of records; internal audits; and control of nonconforming product, corrective action and preventive action). The company may define any additional documentation.
The business systems manual. There are three requirements to be included:
1. A scope that includes any exclusions
2. The procedures or reference to the procedures for the management system
3. A complete description of the interaction between the various processes that are required to operate the business.
These are the only requirements of a manual. Yet so many companies write 30- to 60-page manuals that have so much detail and often refer to outdated processes or requirements. When written correctly, the manual could be a perfect marketing tool to send to customers that simply tells them the scope of the management system and provides a picture of the interrelation of processes. The interrelation of processes can be as simple as an overall picture of how a company’s processes flow, and needs to incorporate control of production/service (planning, measuring and monitoring) and continual improvement processes (control of nonconforming, corrective and preventive action, and internal audit, analysis of data and management review).
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.
Defining Objectives in Measurable Terms
Defining objectives for your quality management system in measurable terms identifies what information you will need to collect. Writing objectives to measure change requires:
1) Be precise about what you are going to achieve, Identifying “what” (On time delivery, Rejection rate, customer satisfaction)
2) Quantify your objectives; use action verbs (reduce, increase, improve, expand, change);
3) Determine whether you are attempting too much? (Are they achievable)
4) Do you have the resources to make the objective happen (men, money, machines, materials)? Are they realistic?
5) State when you will achieve the objective (within a month? By January 2011?) Have an end point.
EXAMPLES:
- We will reduce rework from 6% to 2% by December 2009.
- We will increase our through put rate from 125 quality pieces per shift to 150 quality pieces by January 2010.
- We will improve our delivery performance from 85% to 97% by June 2010.
Do you have objectives that you would like to share with our readers?
Auditing and Continual Improvement
The most important part of the audit is not what the auditor does in collecting the data, but what the manager does with the audit information. Managers must be prepared to take actions to correct audit finding and to recognize excellence. The actions taken to make improvements must not make the situation worse. The best approach is to meet with the people involved in the finding and ask for their ideas for improving the situation and to empower them to solve the problem. This allows them to assume ownership for the problem and for the solution. The manager must then seek commitment from people to resolve the problem within a certain time frame and make resources available to support improvements, if necessary.
The worst possible scenario is for managers to use audit information to punish people. Management must drive fear out of the organization. Punishing people will condition the organization to resist audits and hide problems from management. The manager must learn to receive bad news from an audit as an opportunity for improvement and then involve staff members in resolving the issue. Often the audit will bring to light performance problems that can be solved only by upper management. Although management alone has the authority to change the system, management can usually invite the people who work in the system to help diagnose the problem, make recommendations, and implement solutions for resolving the problem.
Successful organizations are those that learn to place a high value on continuous improvement. Everyone in the organization, from the managers in the strategic center to the individual contributors, must all share a belief in the positive discussion of problems and deficiencies as a necessary first step in achieving excellence.
What are Quality Objectives?
Quality Objectives are the practical outline of the Quality Policy. They are an expression to aim for meeting certain requirements like zero defects for a certain product or a response time below a specified limit for a certain service.
Quality objectives should be measurable, and should be relevant to the various functions within your company. When thinking about what your quality objectives should be, try to think about what ways you want your company to improve your customers’ satisfaction. A good quality objective should include where you are at present state, where you wish to be in the future and when you plan to complete the objective. Example: “We will improve our on time delivery from 85% to 98% by December 2009″.
Quality objectives should be written specifically for your company, and should be relevant to your particular situation.
Quality objectives can be achieved by continual improvement of your organization. The value of having an ISO9001-2008 quality management system is that you should be continually improving your operation.
What are some of your objectives and how have you measured your success?
We’d like to hear your comments on this post.
What is a Quality Management System?
ISO 9000 is a family of standards for quality management systems. ISO 9000 is maintained by ISO, the International Organization for Standardization and is administered by accreditation and certification bodies. The rules are updated, the time and changes in the requirements for quality, motivate change. Recently, on November 15, 2008, has made changes to the requirements of ISO 9001.
Some of the requirements in ISO 9001 (which is one of the standards in the ISO 9000 family) include
- a set of procedures that cover all key processes in the business;
- monitoring processes to ensure they are effective;
- keeping adequate records;
- checking output for defects, with appropriate and corrective action where necessary;
- regularly reviewing individual processes and the quality management system itself for effectiveness; and
- facilitating continual improvement
A company or organization that has been independently audited and certified to be in conformance with ISO 9001 may publicly state that it is “ISO 9001 certified” or “ISO 9001 registered”. Certification to an ISO 9001 standard does not guarantee any quality of end products and services; rather, it certifies that formalized business processes are being applied.
Quality Management Principle (# 7 Factual approach to decision making )
Effective decisions are based on the analysis of data and information
Key benefits:
- Informed decisions.
- An increased ability to demonstrate the effectiveness of past decisions through reference to factual records.
- Increased ability to review, challenge and change opinions and decisions.
Applying the principle of factual approach to decision making typically leads to:
- Ensuring that data and information are sufficiently accurate and reliable.
- Making data accessible to those who need it.
- Analysing data and information using valid methods.
- Making decisions and taking action based on factual analysis, balanced with experience and intuition.
- Stronger quality management systems
Quality Management Principle (# 4 Process approach)
A desired result is achieved more efficiently when activities and related resources are managed as a process.
Key benefits:
- Lower costs and shorter cycle times through effective use of resources.
- Improved, consistent and predictable results.
- Focused and prioritized improvement opportunities.
Applying the principle of process approach typically leads to:
- Systematically defining the activities necessary to obtain a desired result.
- Establishing clear responsibility and accountability for managing key activities.
- Analysing and measuring of the capability of key activities.
- Identifying the interfaces of key activities within and between the functions of the organization.
- Focusing on the factors such as resources, methods, and materials that will improve key activities of the organization.
- Evaluating risks, consequences and impacts of activities on customers, suppliers and other interested parties.
Auditing Your Management Review Process
ISO 9001:2000 requires top management to review the organization’s quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. The review could be carried out at a separate meeting but this is not a requirement of the standard. There are many ways in which top management can review the quality management system such as receiving and reviewing a report generated by the management representative or other personnel, electronic communication or as part of regular management meetings where issues such as budgets and targets are also discussed.
The management review is a process that should be conducted and audited utilizing the process approach.
ISO 9001 clause 5.6.2 specifies the inputs to the management review process and these topics shall be included. However, these are not the only subjects that can be included in a review. Internal auditors should be aware that inputs could be in many forms such as reports, trend charts and so on.
As output from the management review process, there should be evidence of decisions regarding:-
· change of quality policy and objectives,
· plans and possible actions for improvements,
· change of resources,
· revised business plans,
· budgets.
Output is not only related to improvements or changes but could include decisions on other important issues such as plans to introduce new products.
Records of management reviews are required but the format of these is not specified. Minutes of meetings are the most common type of record, but electronic records, statistical charts, presentations etc. could be acceptable types of records.
Auditors should look for evidence that the inputs and outputs of the management review process are relevant to the organization’s size and complexity and that they are used to improve the business. Auditors should also consider how the organization’s management is structured and how the management review process is used within this structure.
Root Cause Analysis
Root Cause Analysis seeks to identify the origin of a problem. It uses a specific set of steps, with associated tools, to find the primary cause of the problem, so that you can:
- Define what happened.
- Define why it happened.
- Determine what to do to reduce the likelihood that it will happen again.
Root Cause Analysis has five identifiable steps.
Step One: Define the Problem
Step Two: Collect Data
Step Three: Identify Possible Causal Factors
Step Four: Identify the Root Cause(s)
Step Five: Recommend and Implement Solutions
As an analytical tool, Root Cause Analysis is an essential way to perform a comprehensive, system-wide review of significant problems as well as the events and factors leading to them.