Evolution of an Audit Program, and Managing ISO 9001:2015 Transition
Terence Paul Malloy, Sr. Quality Specialist, ABB, Lake Mary, FL, USA
Co-Speaker: Jim Murphy
Keywords: ISO 9001:2015 Transition, Internal Audit Program, Auditor Training
One division of ABB in North America has seven different manufacturing facilities, five of which share a common multi-site ISO 9001 registration. This presentation will address how the division s internal audit program evolved from a minimally effective process to a best in class program, and how the division is preparing for the ISO 9001:2015 transition, to include how internal auditors were trained to the new requirements, how procedures and the Quality Manual were revised, and how senior management was trained so they were fully up to speed regarding the new standard.
ABB (www.abb.com) is a leading global technology company in power and automation that enables utility, industry, and transport & infrastructure customers to improve their performance while lowering environmental impact. The ABB Group of companies operates in roughly 100 countries and employs about 135,000 people.
In North America, the Electrification Products Medium Voltage Business Unit manages seven different manufacturing facilities producing a variety of electrical transmission and distribution equipment. Sites are located in Brampton, Ontario, Pinetops, North Carolina, Florence, South Carolina, Napa, California, Coral Springs, Florida, San Luis Potosi, Mexico, and Lake Mary, Florida. Products include Medium Voltage Switchgear, Outdoor Circuit Breakers, Reclosers, Cutouts, current and potential transformers, switches, and legacy circuit breakers. All sites are ISO 9001 certified, while three of the sites are also ISO 14001 certified.
Internal audits are conducted twice per year, with half of the business processes audited in March, and the other half in September. Document control and records are covered in both audits. The audit assignments are managed by the Central Office, who will assign an audit team made up of a mix of veteran and new auditors. Auditors will always be from a different manufacturing facility to assure independence.
Prior to 2006, internal auditors were not required to receive any formal training prior to conducting audits. Each site performed their own audits, with the Quality Department having full responsibility for executing the audits. Numerous problems resulted from this practice; audits were frequently delayed, or missed altogether, auditors were forced to audit their own areas of responsibility, auditors were not adequately trained in the conduct of an audit, and findings were frequently poorly written, or of little value. Senior management placed little importance on the audits because they were not perceived to provide meaningful feedback to the business. Little interaction occurred between the different sites, and the Quality teams were distrustful of sharing information or best practices.
After receiving a nonconformance from our registrar regarding the auditor s lack of training, we implemented a requirement for all lead auditors to receive 3rd party Lead Auditor training from a nationally recognized organization. Typically, this training is over 40 hours in length and include a certification exam. The auditor must then participate in at least one audit under instruction before being qualified to conduct audits independently.
As the benefits of the additional auditor training became apparent in the quality and performance of the audits, additional action was needed to assure auditor independence. The Audit Program Coordinator started assigning an auditor from a different site to conduct the audit. There were a limited number of qualified auditors, however (nine auditors between seven sites), so the audits were conducted by a single individual. In 2011, a dedicated effort began to qualify additional auditors, and to include representatives from departments other than Quality. Each new auditor participated in at least one audit under instruction, then would be partnered with an experienced auditor to gain confidence. Expanding the auditor pool also allowed sending audit teams to the different sites, which resulted in more thorough audits being conducted in a shorter period of time. The quality and value of findings and recommendations also improved, as different sites began to interact and share best practices.
An intangible benefit of the enhanced audit program was the increased interaction of the people from the different manufacturing facilities. A greater level of familiarity and understanding of the strengths of the people and the manufacturing processes encouraged sharing of information, and a willingness to call one another to request assistance. Silos were breaking down, resulting in improved performance and trust throughout the organization.
Starting in 2012, common processes were selected for auditing during each bi-annual cycle. All audit findings were then grouped and disseminated throughout the division to allow better analysis and trending. If a process showed a large number of nonconformities among all the sites, a special Focus Area audit checklist was prepared and executed during the next audit cycle at all sites to help bring extra attention to the process. Focus Area checklists have now been developed for Document Control, Management Review, Material Identification and Control, Quality Objectives/Process Measurement, and Inventory Management. Audits in subsequent years showed improvements in each area where the focus area audits were conducted.
Safety is a core value for ABB. Beginning in 2012, each internal audit also included a Safety Observation Tour, where any safety issues were documented as a nonconformity against the Work Environment. Since then, 56 Safety findings have been generated, addressing more than 170 individual deficiencies.
Growing the pool of trained auditors has continued to be a priority, with at least three new qualified auditors being added yearly. Presently, the division has 25 qualified auditors, with over 130 years of cumulative auditing experience. Our Registrar has indicated our internal audit program is considered one of the organization s strengths.
As a voting member of the US TAG to TC176, I received early exposure to the ISO 9001:2015 revision and the new concepts being introduced into the standard. Once the final standard was published, I developed a timeline for achieving the updated certification. It started with preparing our internal auditors with a two-day training session early in 2016 that included a competency examination. The corporate procedures and Quality Manual were revised to reflect the 2015 standard, and included key concepts such as context of the organization and risk based thinking . Senior management was briefed on the changes, with emphasis on their increased involvement and ownership of the quality objectives. The March and September internal audits covered both the 2008 and 2015 standards. Management Review in 1Q 2017 will be performed to the 2015 standard, and a 2-phase certification audits will be performed by the registrar in 2Q17.
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“ISO 9001 is used by millions of people and organisations around the world and the upcoming 2015 revision will have a big impact on those who work with the standard.
The impact of this revision will be similar to, if not greater than the 2000 edition, which was a major change for accreditation bodies, certification bodies, training organisations, implementing organisations, procurement organisations, consultants and customers.”
An excerpt from IRCA Resources on “ISO 9001: IRCA Supporting the 2015 Revision”, October 2013