|
|||||||||||||||||||||||||||||||||||||||
Greetings! Welcome to Sustaining Edge Solutions E- Newsletter Our newsletters provide guidance on operational and quality systems ISO 9001, AS9100, ISO/TS 16949, TL 9000, ISO 13485, ISO 14001, and others. This includes process improvement methods Six Sigma, lean enterprise, and other topics of interest to our readers. 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. Thanks for your Support!
![]() Based on reader feedback, each monthly issue will review a “How To” topic regarding Internal Audit Methods. If you have a topic in mind, let us know. Thanks to our loyal readers for the feedback!
The objective of auditing the design and development process is to determine whether it is managed and controlled to enable products to meet their intended use and specified requirements. In order for the auditor to determine if the organization is in fact involved in design and development, auditors need to establish who is responsible for defining the characteristics of the product or service together with how and when this is carried out. Auditors should establish what design and development projects have been, and are currently being, undertaken. Auditors should select a sufficient number of projects to be able to audit all stages of the design process. The need for design and development is generated from a number of sources including:
Auditors should evaluate whether organizations have in place, and perform, activities for the review of such needs. How is the decision to proceed with design and development taken, i.e. have risks and cost implications been considered and have all relevant functions (internal or external) been consulted. The following issues should be considered when auditing the Planning Function:
When auditing the design and development inputs, auditors should develop an understanding of how the organization identifies its own inputs based on:
Auditors should evaluate the risks, the possible implications for customer satisfaction and issues that the organization may encounter if some relevant inputs are not considered. The design and development outputs should comply with the identified needs in order to ensure that the resulting product can fulfill its intended use. Outputs can include information relevant to the following:
Auditors should obtain evidence from projects to confirm that information from stage completion is available; process is completed based on stage review; and outputs have been confirmed.
![]()
![]() Dr. Edwards Deming once stated “Common sense isn’t so common.” One of the most effective ways for any organization to gain profound knowledge is to learn from others mistakes. Quality Digest Magazine/February 2007 article by Craig Cochran identifies 10 quality mistakes that are preventable. We also have witnessed these mistakes and want to share our thoughts.
1. Limiting quality objectives to traditional quality topics. 2. Holding infrequent (and redundant) management reviews. 3. Sending out long, complex customer surveys. 4. Assuming everyone knows what “nonconforming” looks like. 5. Failing to use the corrective action process effectively. 6. Applying document control only to official documents. 7. Focusing audits on non-strategic details. 8. Training some personnel, but not all. 9. Doing anything just because an external auditor told you to do it. 10. Having someone who only oversee the QMS.
![]()
ISO 9001 requirements can help you meet the 2007 deadline for complying with SOx Section 404. ISO 9001 can provide objective evidence that an organization is operating with the proper controls, policies, procedures and practices. ISO 9001 gives attention to the operational controls–such as booking customer orders, purchasing raw materials, fulfilling orders, and handling customer returns and complaints–that help ensure customer requirements are met. Those same operational controls are the foundation for much of the organization’s financial data (e.g., inventory, revenue, customer credits and/or allowances). Even ISO 9001’s requirements related to job duties, responsibilities and communications throughout the company contribute to the “control environment” that’s so important for the credibility of financial information. A practical way to begin is with your existing ISO 9001 internal audit program. Using the similarities and parallels between ISO 9001 and SOx requirements, expand existing ISO 9001 audits to include more auditing of operational controls and their related financial activities. Undoubtedly you’ll need the assistance of your accounting manager, financial internal auditor and others who’ve been involved with financial-based audits. They’ll know the significant financial accounts, related assertions and control objectives that should be audited and tested. One way to help your ISO 9001 internal auditors execute an integrated audit is to provide some sample audit questions. This gives them a better sense of how to carry their normal QMS auditing farther to reach the financial transactions related to the ISO 9001 operational controls. These audit questions should also help auditors stay focused on the five aspects of internal control as they relate to the topics and/or the process of being audited. ![]()
The implementation of Six Sigma at an Illinois hospital has saved it millions of dollars–and simultaneously dramatically improved patient satisfaction. Decatur Memorial Hospital reports that 10 months after it installed patient-safety technology from Omnicell Inc., it was more than $2 million under budget in its drug department and $750,000 under budget for pharmacy labor. Decatur’s team used a Six Sigma approach to analyze the hospital’s medication-use process, and then looked for automation approaches to help streamline the process. The team identified 132 steps in the hospital’s patient drug-delivery system; 42 were eliminated through subsequent automation projects. In addition, the hospital reduced the time it takes to dispense and administer drugs to patients from 186 minutes to 104 minutes. “Medication errors have dropped 70 percent, with very few of the more serious med errors,” says Ron Wolschlag, director of the hospital’s pharmacy. “Our nurses are much happier with the new system because it makes them much more efficient and gives them more time for patient care.” ![]()
![]()
To see the course description, schedule, and on-line registration click on the course title below. Courses are awarded Continuing Education Units.
All courses can be delivered at your company. Don’t see a course, location, or date that fits your needs? ![]()
|
|||||||||||||||||||||||||||||||||||||||
email: wtighe@sustainingedge.com
phone: 888-572-9642
|
Auditing Design and Development Process
Comments are closed.