February 23rd, 2014
We just attended the National Quality Assurance (NQA) Auditors and Consultants Conference in Phoenix, Arizona. We look forward to this two-day event annually due to the great information that is distributed to all attendees.
We want to share some of the information (more to come in next post) heard regarding the International Aerospace Quality Group (IAQG) and future AS9100 series documentation changes/requirements.
- IAQG potential reduction of Certification Boards (CBs) certifying to AS9100. Informed that the number may be 8 CBs.
- Removal of CB auditors that “Don’t follow the Rules” regarding AS9101D requirements.
- Issues about poorly written PEARS and poor root cause definition.
- AS9101E – Expect spring 2014 release. No cost to clients, auditors will undergo online training requirement.
- Appendix A, AS9101D being removed for AS9101E. The OER and PEAR will become one – The New PEAR.
- The OER will be in a newly reformatted method.
- Auditing all shifts for AQMS required. All audit team members must be aware of AS9104/1 requirements.
- The same CB audit team leader can only lead two consecutive audit cycles
- Client suspension process will take place 60 days of the NCR issuance if client cannot demonstrate conformance to the standard.
- PEARS will be required for All product realization processes.
More information to follow soon.
January 14th, 2014
In a Booz & Company survey conducted in December 2013, executives from around the world, 60% were not able to say affirmatively that their companies’ strategy would lead to success, as of the end of 2013.
Three years ago, 52% expressed this lack of confidence in their company strategy. The survey, overall, has involved 3,855 participants since 2010. It is not clear whether the dip in executives’ faith in their strategy is related to the external environment, or other factors. It appears that business leaders have a range of frustrations, most relating to the clarity and focus of their strategy. In fact, most leaders – 66% – said “having too many priorities” is a major point of frustration for their organizations management team.
The survey shows…
- More than half of executives (51%) said that communicating the company’s strategy and getting buy-in for it is a significant challenge at their company.
- 55% said ensuring day-to-day decisions are in line with the strategy is a significant challenge.
- 56% said allocating resources in a way that really supports the strategy represents a big challenge.
And 54% said quickly translating strategic and operational decisions into action is a challenge. With the faster pace and ever changing business climates today, this survey reflects that companies are struggling with developing and executing a winning strategy.
December 15th, 2013
As we have written in prior posts, the future ISO 9001:2015 standard will take a risk-based approach requirement to determine the type and extent of controls appropriate to each external provider, and all external provision of goods and services. The proposed standard addresses, for example risks which can affect conformity of goods and services as well as customer satisfaction.
Published in 2009, ISO 31000:2009, Risk management – Principles and guidelines, provides principles, framework and a process for managing risk.
Now, ISO has just published a guidance document which aims to help organizations implement the ISO 31000 risk management standard.
The new 37 page document, entitled ISO/TR 31004:2013 ‘Risk Management: Guidance for the implementation of ISO 31000′ provides:
- A structured approach for organizations to transition their risk management arrangements in order to be consistent with ISO 31000, in a manner tailored to the characteristics of the organization;
- An explanation of the underlying concepts of ISO 31000;
- Guidance on aspects of the principles and risk management framework that are described in ISO 31000.
The new ISO/TR 31004:2013, Risk Management – Guidance for the implementation of ISO 31000, will help organizations smoothly align their risk management practices to ISO 31000. ISO/TR 31004 will help you establish or align a system to detect, understand and manage risk based on ISO 31000 – an internationally-recognized generic document on managing risk in organizations of all types and sizes.
For more information and to purchase the standard, visit the ISO Store.
Season’s Greetings to ALL OUR READERS!!
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.