November 19th, 2013
When effectively implemented, internal auditing can be considered the most important tool in your business management system. It’s the primary method for continuously monitoring a company’s business management system (BMS). In fact, the feedback from internal auditing is critical to the growth of business effectiveness and the standardization of effective processes.
Through an audit, an organization can identify a system’s ineffectiveness, take corrective action, and ultimately support continuous improvement. Unfortunately, a poorly deployed internal auditing system can lead to increased nonvalue-added costs, many hours of wasted human resources, and a BMS breakdown.
The following is an example of a common pitfall to poor and ineffective internal audit deployment: Not understanding the definition of, and not basing audits on status and importance.
Status and importance can be interpreted differently, but their intent is often misunderstood. Status can be defined as how a particular department, discipline, facility, or process is performing against established policies, goals, objectives, and expectations.
Some questions to ask when considering status include:
- What are the performance indicators for an area, group, or department reflecting?
- What does the performance history indicate?
- Have these indicators been the result of root cause corrective actions? Are they recurring?
- Have there been changes in process, equipment, personnel, or management?
- Has the area or department been restructured or reorganized?
When scheduling internal audits, consider other important aspects such as:
- What’s been the past performance history?
- Are there any new employees, equipment, or management personnel?
- How effective is the training system?
- What do past audit results indicate?
- How critical is that area? (risk or customer touch point).
When you build your company audit plan on status and importance your focus is process oriented, not checklist mandated. Truly effective audits don’t just concentrate on process weakness, but on process potential.
October 22nd, 2013
In October, Sustaining Edge Solutions was a proud Sponsor and Exhibitor at the American Society for Quality (ASQ) 22nd Annual Audit Division and Quality Management Division Conference. This conference was well received by all, and we made some great connections with many of our booth visitors.
One of the breakout sessions that caught our interest was titled “ISO 9001:2015 -A Sneak Peak at the Draft Standard.” The following is information we collected during the presentation from the presenter, a member of the United States TAG (Technical Advisory Group). Keep in mind that this information is derived from the current Committee Draft.
- The PDCA Model will not be identified in the ISO 9001:2015 and no formal requirement for risk management.
- A defined Management Representative has been removed; however actions are still applicable.
- Top Management shall be “Accountable” for QMS Effectiveness. +
- Quality objectives will include: What, who, where, and when – results will be evaluated. +
- Competencies requirements will remain, but knowledge is new.
- Many of the current Calibration Requirements have been removed to apply to service organizations
- Replaced the word product with goods and services.
- Evaluate performance and effectiveness of QMS – KPIs +
- Internal audit reference ”status and importance of processes” is replaced with “consideration of quality processes and the importance of processes concerned.”
- The organization shall “improve the QMS.” Note: This is not continual improvement.
This journey to the new ISO 9001 revision should be quite a ride; with more changes we are sure to hear about. Stay tuned, we will keep you informed.
September 28th, 2013
Selecting the right quality measures can have a tremendous impact on overall performance outcomes and the culture of quality throughout an organization. The challenge is figuring out the right balance to ensure that measures are not so standardized that they lose the value to affect performance.
The Discoveries 2013 Global State of Quality Research identified the following measures being used:
- Defects per million: 82% manufacturing vs. 38% service
- First pass yield: 88% manufacturing vs. 43% service
- Percent on-time delivery: 97% manufacturing vs. 58% service
- Measures of safety: 96% manufacturing vs. 63% service
- Internal failures: 96% manufacturing vs. 67% service
- Percent compliant: 96% manufacturing vs. 83% service
- Employee satisfaction: 91% manufacturing vs. 94% service
- Customer satisfaction: 98% manufacturing vs. 96% service
Question: Although the percent usage is interesting, an obvious question comes to mind: Why aren’t these quality measures being used more?
Using Quality Measures
Organizations can use quality measures in the establishment of strategic goals, for trending and predictive analysis to enable pre-emptive and not just reactive decision making, and in rewarding employees through performance compensation. Data show that the majority of organizations use measures in a more mature way, but there are a few significant differences among manufacturing, services, and healthcare respondents.
Only 59% with distributed governance (decentralized quality responsibilities) of quality use measures to drive performance, whereas usage is 81% of organizations that manage quality by a functional central group.
Question: Why the large difference? Give us your thoughts on these questions; and is your organization using the same types of quality measures?
August 29th, 2013
The International Accreditation Forum (IAF) recently undertook a global survey to capture market feedback on the value of certification. The results show that not only is certification being used as a tool to deliver internal business improvement and to meet regulatory compliance, but businesses confirm that it has a positive effect on revenue. Read the full report here.
A recent survey by the International Accreditation Forum (IAF) has found that organizations are finding real value from having accredited certification.
The main findings of the report showed:
- Approx. 50% of the 4000 respondents, reported an increase in sales as a result of certification.
- In terms of general added value, 80% felt that certification had given them this.
- Nearly 50% cited internal business improvement as the main reason for seeking certification.
- An overwhelming number of respondents cited certification as being important to their customers.
- 80% reported that certification has helped them to meet national regulatory requirements.
Regarding the importance of certification bodies:
- Nearly 75% of respondents said that accreditation was essential or very important in their industry.
- 62% agreed that certification bodies provide value for money.
Further tangible value respondents stated included:
(47%) of respondents stated that the primary driver was to improve internal business operations and processes.
(89%) confirmed that they commission the services of a certification body based in their national economy.
(62%) of respondents confirmed that they strongly agreed or agreed that the certification process provided value for money.
What value has certification brought to your organization? Let us Know!
July 26th, 2013
ISO 9001, Quality Management Systems – Requirements, has reached the Committee Draft stage of the revision process. Like all ISO standards, ISO 9001 undergoes a revision every five years to ensure it remains a useful tool.
What is the Committee Draft stage?
The Committee Draft stage is the first consultation in the development (or revision) of an ISO standard. During this stage, the countries (ISO members) that have chosen to participate in the development of the standard have between two and four months to form a national position on the draft and comment on it. Some members may decide to get input from the public to help form this national position, but this is not the official public comment stage.
What happens next?
Once the national positions have been submitted, the standard revision process follows its course.
Experts (nominated by the ISO member in the participating countries) continue to meet to discuss any problems or questions highlighted, until a Draft International Standard is published. The draft then goes out for public comment. Anyone who is interested can contact their national member body with feedback on the draft standard. This is likely to take place during the first half of 2014.
Once the draft has been finalized and accepted, it is published and the date following the standard’s number is updated (for example ISO 9001:2015).
I am using ISO 9001:2008. What does this means for me?
We expect to publish the new version of ISO 9001:2008 by the end of 2015. At that point there will be a transition period (usually two years) before ISO 9001:2008 officially becomes out of date.
More information on the standards development process can be found here. Looking for more information on the future revision, contact us!