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Our newsletters provide guidance on ISO 9001, AS9100, ISO 13485, ISO/TS 16949, TL 9000, ISO 14001, ISO 27001, ISO 20000, ISO 22000, and related ISO standards, as well as, Six Sigma.
If you have any questions about the articles appearing in this issue, or you want to suggest topics for future issues, please let us know.
Free Magazines
Are you taking advantage of the free magazines available in your industry? I've listed several web sites that offer free subscriptions to trade magazines.
The Business News Publishing Company offers free subscriptions to more than 40 magazines, including Quality, Assembly, Pollution Engineering, and Packaging Strategies.
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TradePub.com has an extensive list of magazines available for a free subscription. Titles include Global Finance, Evaluation Engineering, eWeek, and Consulting Magazine.
Free Trade Magazine Source has over a hundred free magazines, including Human Resource Executive, Equipment World, Integrated Solutions, and Industrial Equipment News.
The Business Magazine Network has hundreds of business magazines available for free, including titles such as Information Week, Call Center, Successful Meetings, and Network World.
How Do You Audit the Analysis of Data?
How do you audit conformity to ISO 9001:2000, clause 8.4, Analysis of Data? Or, do you audit it? Unfortunately, some auditors say they don't, at least not directly.
We should start by recognizing the importance of the requirement; it is one of the eight principles of quality management. ISO 9000, Clause 0.2.g, lists the 7th principle as the "Factual Approach to Decision Making" and explains that effective decisions are based on the analysis of data.
Analyzing data is an essential activity for improving your system and its processes, as well as, your products and services. Data collection has no purpose if the data isn't examined, evaluated, analyzed, and converted into proposals for decision making.
To judge conformity to the audit criteria, you must clearly understand the requirement.
Clause 8.4 begins, "The organization shall determine, collect, and analyze appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvement of the effectiveness of the quality management system can be made."
The Guidance on Terminology resource at the ISO web site defines the term "analysis" as the breaking up of something complex into its various simple elements.
The reason to separate something into its elements is to determine either their nature (qualitative analysis) or their proportions (quantitative analysis).
Therefore, we analyze the data to show the quality management system is effective (achieving planned results) and to spot where improvements can be made. It is not enough to just collect the data, we must analyze it and reach some conclusions.
Also, Clause 8.4 links back to Clauses 4.1.e and 4.1.f, which state, "The organization shall monitor, measure, and analyze these processes, and implement actions necessary to achieve planned results and continual improvement of these processes."
Clause 8.4 continues, "This shall include data generated as a result of monitoring and measurement and from other relevant sources."
This requirement emphasizes that the data we collect, especially numerical facts, are to be included in the analysis.
As a result of the monitoring and measurement activities called for by ISO 9001:2000, Clauses 8.2.3 and 8.2.4, you will have collected a lot of data, which can be analyzed to indicate trends. Any trends you may find could suggest where there are problems in your quality management system and indicate areas where improvements are needed.
Clause 8.4 also links back to Clause 8.1, which states, "The organization shall plan and implement the monitoring, measurement, analysis, and improvement processes needed to demonstrate conformity of the product, ensure conformity of the quality management system, and continually improve the effectiveness of the quality management system."
Clause 8.1 also states, "This shall include determination of applicable methods, including statistical techniques, and the extent of their use." So, you must consider and identify the methods to be used for analysis. And, you may find that statistical techniques are useful tools for the analysis process.
Clause 8.4 concludes, "The analysis of data shall provide information relating to:
a) customer satisfaction (see 8.2.1),
b) conformity to product requirements (see 7.2.1),
c) characteristics and trends of processes and products including opportunities for preventive action, and
d) suppliers."
The analysis of the "data" is to provide "information", which means to convey the knowledge derived from the analysis. The results can be used to assess customer satisfaction, provide evidence of meeting product requirements, make decisions on corrective and preventive actions, and evaluate supplier eligibility and performance.
Analysis of data is also mentioned in Clause 8.5.1, Continual Improvement. It states that "The organization shall continually improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review."
Turning our attention to the corresponding Clause 8.4 of the ISO 9004 guidelines standard, it says that decisions should be based on an analysis of measurement data and collected information. You should analyze data to:
Assess performance against plans, objectives, and other defined goals
Identify areas for improvement and possible benefits to interested parties
It states that decisions based on facts require effective and efficient actions, such as:
Valid analysis methods
Appropriate statistical techniques
Making decisions and taking actions based on results of logical analyses, as balanced with experience and intuition
Analysis of data can help to determine the root cause of existing or potential problems, and thereby guide decisions about corrective and preventive actions need for improvement.
For an effective evaluation by management of the total performance of an organization, data from all parts of the organization should be integrated and analyzed.
The overall performance should be presented in a format that is suitable for different levels of the organization. The results of this analysis can be used to determine:
Trends; customer satisfaction (and satisfaction of other interested parties)
Process effectiveness and efficiency; supplier contribution
Success of performance improvement objectives
Economics of quality, financial, and market-related performance
Performance benchmarking; competitiveness
Back to our original question: How do you audit the analysis of data? Well, it can be hard to assess because ISO 9001:2000 doesn't say what data should be collected or how to analyze the data. The requirement calls for analysis of the "appropriate" data.
Begin by looking at the results of the data analysis implied by other clauses:
Are they evaluating performance against their quality objectives (5.4.1)?
Do they know their current level of customer satisfaction (8.2.1)?
Are they determining the effectiveness of their key processes (8.2.2)?
Are they determining their level of conformity to product requirements (8.2.4)?
Do they track the performance of their existing suppliers (7.4.1)?
Are they examining trends to identify preventive actions? (8.2.3)
If any of this information is missing or incomplete, see if the data is being collected and not analyzed, or if the data is just not being gathered. Writing a more specific finding will help the organization focus on the appropriate data and its analysis.
Interested in an quality auditing course? Click on the course title below to see the class schedule.
ISO 9001:2000 recognizes the importance of communication by stating in clause 5.5.3 that the appropriate communication processes must be established within the organization. And, in clause 7.2.3, the standard adds that the organization must determine and implement effective arrangements for communicating with customers.
According to the HR Daily Advisor, a study by Sirota Survey Intelligence shows that the lack of communication is a key reason why initially enthusiastic employees become unmotivated in as little as 6 months after joining their organizations. The survey also shows that a company's performance at communicating lags far behind any other facet of organizational performance.
Lack of communication is obviously a serious shortcoming. Without communication, teams can't work together. And, customers are misunderstood. Leaders may try to lead, but without effective communication, employees may not know how to follow.
To improve communication, an article in the HR Daily Advisor suggests these strategies:
Communication begins before conversation. Studies show that 40 percent of what is communicated comes through body language and tone of voice. Both should match the message being delivered. For example, if you say a mistake is not really a big deal, don't send a different signal by rolling your eyes and wincing.
Communication starts with a name. Nothing establishes rapport better than acknowledging others by their name. But in today's transient world, names are easy to forget or confuse. Use a memory technique such as connecting the person's name with someone famous. If you meet George, mentally connect him to George Washington.
Start with small talk. Chatting amiably opens the door to more substantial messages, but, monitor the person's reaction so you don't go on too long ... and never talk about workplace confidences or gossip.
Tailor conversation to your audience. Talks with a boss, co-worker, or customer require different styles. With bosses, pick the right time and ask honestly for what you need and what they can reasonably deliver. For co-workers, be humble, reliable, and discreet. If customers call with problems, listen, apologize, and offer a solution. And a natural smile, when appropriate, applies in all cases, even on the phone.
Consider your audience when writing. Develop your message for the intended audience and use the appropriate media for communication. Remember that others beyond the intended recipient, and perhaps into the future, may read your written words. Never write what you wouldn't want to be openly read.
Conduct more effective meetings. Nothing in business seems to irritate people more than useless meetings. So, meet only when necessary, with only the required participants, and always with an agenda. End the meeting by summarizing the decisions and actions. Thank everyone for their involvement. Send them off on a positive note.
If you'd like to subscribe to the HR Daily Advisor, go to the Business & Legal Reports web site.
Audit Interviews
When you audit a process, you can look for evidence by observing the process, reviewing its documents, and examining its records. However, an important source of evidence is the information gained through interviews. A quick overview of the interview process is shown below:
Interview reasons
Supplements the documented process
Determines the actual defined process
Principal way of obtaining information
Allows auditee to explain work practices
Ascertains understanding; commitment
Interview steps
Interview persons at their workplace
Conduct interviews during normal hours
Put person at ease (lower anxiety level)
Explain your purpose (what you want)
Ask about their job (question; observe)
Verify responses (confirm understanding)
Check the facts (use other sources)
Record evidence (notes on checklist)
Make tentative conclusion (no secrets)
Give opportunity to discuss other topics
Thank for their time and cooperation
Remember, it is an interview, not an interrogation!
Industry Week recently published the results of their 2007 IW/MPI Census of Manufacturers. Response summaries are shown below for improvement methodologies in use, strategic practices, and focus of market strategies. Please note that multiple responses were allowed.
Improvement Methodologies in Use
Lean Manufacturing = 69.6%
Total Quality Management = 34.2%
Six Sigma = 29.0%
Toyota Production System = 17.0%
Theory of Constraints = 14.4%
Agile Manufacturing = 6.4%
Other = 14.6%
None = 11.6%
Strategic Practices
Continuous Improvement = 76.9%
Recycling/Reuse Program = 56.1%
Quality Certifications (e.g., ISO) = 55.9%
Customer Satisfaction Surveys = 51/4%
Value Stream Mapping = 45.5%
Kaizen Events/Blitzing = 45.5%
Environmental Management = 43.6%
Benchmarking = 42.5%
Supplier Management Program = 36.1%
Total Productive Maintenance = 34.2%
Energy Management = 32.8%
Quick Changeovers 29.3%
Strategy/Policy Deployment = 26.9%
Open-Book Management = 16.0%
None of These = 4.0%
Focus of Market Strategy
High Quality = 73.7%
Service and Support = 55.8%
Total Value = 41.2%
Fast Delivery = 32.0%
Customization = 26.6%
Innovation = 26.8%
Low Cost = 26.8%
Product Variety = 13.4%
None of These = 0.0%
Whittington & Associates provides training, consulting and auditing services for
quality systems based on
ISO 9001, ISO/TS16949, TL9000, AS9100, ISO 13485,
as well as, ISO 27001, ISO 20000, ISO 22000, and ISO 14001.
