Working late, your staff struggles to update the company's documentation in preparation for the
upcoming visit from your company's quality registrar's auditor. The old qual- ity-system documentation lacks some of the newer processes, and the product design documents predate the current
product revision level by several months. The new manufacturing line's operational documentation drafts need final approval, but they're undoubtedly at the bottom of someone's in-basket. The
manufacturing defect and data collection sheets need to be logged and tallied. Also, the operations manager needs to be briefed on the best way to field the auditor's questions. The staff had
intended to keep the data collection system up to date, but the aggressive manufacturing schedule took priority. Meanwhile, at the local economy motel across town, the
auditor pours over documents from the previous auditor's visit to your company. The remains of yet another fast-food dinner litter the desk, along with the draft final report for the company that
he audited earlier that day. The final report for that audit is due first thing in the morning, and your company's audit will begin soon after. Your previous auditor's notes on your company were
compiled in a room just like this one late on the last day of your previous surveillance audit. That auditor has since moved on to work for another firm with more regular hours, less travel and
an increased salary--due compensation for her industry knowledge. All too often, this is the reality behind the quality registration and maintenance process. Instead of adding
value by ensuring operational and business consistency and excellence, the process has become an exercise in documenting and verifying what should or could be rather than what is.
Registration and surveillance audits keep auditors on the road continuously. To maximize time spent with customer staff, auditors do much of the pre- and post-audit work after 5:00 p.m. and
before 8:00 a.m. Burnout is common, and expertise is diminished by high turnover rates. The work is interesting and varied, but the schedule takes its toll. Auditors are
committed to providing thorough reviews of a company's processes and documentation to help the company maintain its operational excellence. Stretched across multiple sites and multiple
industries, registrars are challenged to provide expert auditors who are familiar enough with a wide variety of industries and operations to provide valuable feedback about what is working well
and what needs improvement. Often, company preparations for initial registration lack the systemic modifications necessary for sustaining continuous quality. The products and
processes are documented, and data is gathered about the current state of operations. There may even be plans for ongoing process improvements, but with registration in hand, priorities shift.
Documents aren't updated, changes aren't always tracked or approved, data are either not gathered or not analyzed, and decisions about product and process improvements are made without the
benefit of quality management metrics information. The quality process and its associated documentation become add-ons to the company's normal operation. Work flow, product development and
business processes are managed and modified on a day-to-day basis, but the measurement and documentation processes only become high priority when an audit is imminent. Quality is still not an
integral part of the company's operations; instead, it's added overhead. The cycle is repeated without fail for each subsequent surveillance audit. Resources are diverted from
getting product "out the door" to getting ready for the next audit. The registrar's surveillance audit process may drive periodic improvement cycles, but the intended benefits from the quality
registration process, such as process improvement and better communication, aren't realized. Online document control You can break this cycle and reap the true benefits of quality standards by eliminating the paper and integrating the quality process into daily operations. Automate your
company's product and process documentation and metrics tracking using not just a system of databases to store what is currently captured on paper but an online system for creating and
maintaining process and product life cycle documentation, change management, and approval routing online. Such a system should track end-to-end product and process quality metrics and customer
feedback online and automate document creation and change management. It should also allow your company to automate the collection, correlation and analysis of process and product metrics data.
Such a system can provide the foundation for ongoing process and product lifecycle improvements. A paperless system can also: Reduce the resources required to maintain the documentation and metrics data. Increase the amount and quality of information available for product and
process decision making.
Shorten the product and process change cycle by automating data collection and document routing and approval processes. Provide fast access to current, as-is product and process lifecycle information and metric data. Require less auditor time and the expenditure of fewer company resources. Remote and paperless assessment systems
RPAS InformationFor more
information about the RPAS initiative, please contact: Stanley H. Salot Jr., Business and Quality Management Systems Inc. Phone: (510) 739-1072o E-mail: ssalot@qualitydigest.com Kam Wong, Hitachi Koki Imaging Solutions Inc. Phone: (805) 578-4460 E-mail: kwong@hitachi-hkis.com Bruce Kendall, ABS InfoLink Phone: (281) 877-6526 E-mail: bkendall@eagle.org Harvey Berman, Underwriters Laboratory Phone:
(516) 271-6200 E-mail: harvey.s.berman@us.ul.com
|
|
Consider improving the effectiveness of surveillance audits even more by
using remote information exchange. A remote and paperless assessment system (RPAS) combines the benefits of the online, paperless quality system with the benefits of
remote information exchange. The International Electrotechnical Commission (IEC) is one of the bodies entrusted by the World Trade Organization to moni-tor national and
regional organizations' application of international business, product, process and quality standards. The IEC is responsible for international standards that provide the basis for
economical design, improved product and service quality, increased process interoperability, and consistent production and delivery efficiency of electrical and electronic
products and related products and processes. The U.S. National Authorized Institution, which manages U.S. representation in the IEC's Certification
Management Committee (CMC), has chartered an RPAS guidance team to prepare draft standards and guidelines for RPAS, extending the current
assessment requirement documentation. The team's goal is to provide informative documentation that supplies guidelines and minimum requirements
for issues such as content and access security, activity logging, system integrity, corporate data confidentiality, and common technical implementation specifications.
RPAS pilot participants will help the guidance team evaluate and enhance the draft documents. Once the first drafts have been completed, they will be
circulated throughout the industry to ensure that they represent common industry understanding before going on to the IEC's CMC for final recommendation as
an international standard. IEC's Web site, www.iec.ch, offers additional information about the organization and its processes.
Why use RPAS? With remote access for viewing a company's online documentation system, a registrar's surveillance assessor can read and review product and process
documentation without incurring travel time and cost or tying up company resources. Questions and requests for clarification can be handled using special
documents within the company's automated system or via e-mail. A documentation trail can be automatically generated for future reference. Any
required on-site visits can be focused on issues that truly require direct interface. The result will be more efficient and cost-effective assessments.
The RPAS is generating a great deal of interest among quality professionals, leading industry companies and registrars in both the United States and
international business communities. Companies will have real-time online documentation and metrics for their products and processes. Registrars will
have remote access to this information as needed in a manner that protects the company's proprietary information while enabling more effective assessments
for its customers. New and modified processes and products will be documented as part of the normal lifecycle management processes. The latest
information will be continuously available to the company's internal staff and analysis processes. This means no more eleventh-hour pushes driven by
assessment schedules; no more product or process decisions made without sufficient metrics information; and no more last-minute preassessment
documentation packages to prepare, send, receive and review. Companies and their registrars can work together with renewed focus on the
value added by efficient processes that are well-documented, effectively monitored and continually reviewed to maximize quality, safety, efficiency, profit
and customer satisfaction. This will return the registration and surveillance processes back to their original purpose: assessment of system compliance to the standard.
RPAS between registration bodies and their customers can and will be implemented in many different ways. To ensure consistency among diverse
implementations, guidelines and minimum requirements need to be established. Each RPAS implementation needs to consistently support the intent of the
quality assessment process and the current and future ISO standards. The future holds exciting new developments for quality professionals. RPAS
will be the basis for part of that future. Companies and registrars can renew the focus on added business value through improved quality and cease to view ISO
9000 registration and surveillance as a process add-on. About the author
Stanley H. Salot Jr. is president and CEO of Business & Quality Management Systems Inc. (BQMS), a consulting firm that works with
customers to examine their business and quality systems in preparation for ISO 9000 registration. He is an active consultant and has experience in
product engineering, manufacturing process management and business management. Salot was a manager and an active auditor for the National
Standards Authority of Ireland, an international quality registrar. He has recently accepted the position as acting chair of the Remote and Paperless
Assessment Systems Guide- lines Team for the U.S. NAI of the IEC's Certification Management Committee. E-mail him at ssalot@qualitydigest.com . |