Quality Management 2.0 Blog

ISO 9001:2008 Surveillance Audits

Posted by Mary McAtee on Dec 19, 2014 @ 11:06 AM

Old Dog, New Tricksold-dog-new-tricks

Last week was our annual ISO 9001:2008 surveillance Audit. Thousands of companies have depended on us for advice and support in achieving and maximizing the value of their registration efforts. It was to be expected that we would do well and we did. Lapses in compliance could not be blamed on ignorance of the requirements or not understanding what the auditor’s expectations would be. This was a particularly challenging year for IBS as a company. Siemens completed their acquisition of IBS and began the exciting but demanding process of integrating us into the “Digital Factory” Group. This integration resulted in new systems and processes to learn and master. The impact rippled through documentation updates, training requirements, Assessment criteria and almost every facet of our Quality Management System and business processes. We have been registered for over 15 years and we have enough Lead Assessors on staff to populate our own Registrar. It is easy to fall into a compliance rut, same process, same training, etc. This year under the leadership of a new CEO, who understood the value as well as the challenge of organizational change, we were encouraged to form teams to rethink processes and people. Everyone in the organization moved out of their comfort zone to accept new responsibilities and to update and redefine almost every business and quality process. Utilizing the Management Review process we defined a framework of measureable quality objectives that mapped to our business plan goals for the year.

Quality and business process documentation was overhauled to match new requirements. Training was conducted at every level of the organization to assure people were prepared and capable of fulfilling new responsibilities. The Organization Chart reflected an entirely new mindset with many of the same strong contributors taking on new responsibilities. This enabled them to mentor the new employees who will form the next generation of the company.

As the Management Representative, it was my responsibility to assure that our core quality and business processes continued to track and remained compliant throughout all of the changes. Fortunately for me, the importance of every aspect of our QMS and Registration is crystal clear and an ingrained part of the business mechanics for everyone involved. I started by having our CEO explain the changes and all the moving parts impacting our business to the auditor. Our Management Review Minutes and Quality Objectives tracked seamlessly with the CEO’s narrative. As we moved through the areas selected for assessment by our Registrar he took an approach that I found to be a real “teachable moment” for me. He started with our process document for each area and asked the person he was interviewing to consider him “the new guy”.  This both put the person being interviewed at ease in speaking to responsibilities they were very familiar with, as the auditor followed along through their working documentation and evidence records. It was a wonderful way to verify all the aspects at once: Standard Operating Procedures, Work Instructions, Master Forms and Training for their use as well as Corrective and Preventive Actions, Customer Requirements and Complaints. Personnel walked him through change documentation and updated Supplier Management and Risk Assessment processes. Taking this approach of patiently permitting the employee to move through every aspect of a process from input to handoff to the next process element as an output gave a very reliable overview of the accuracy and capability of both the process and the people involved. The employees themselves identified some areas that we chose to focus on as opportunities for continuous improvement.

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The big takeaway for me from the experience was the following:

  • The importance of having a realistic approach to process and supporting documentation. If our processes were simply a compliance layer we applied in addition to how we actually do business this would have been much more difficult for everyone involved. What we document is what we do, it’s that simple a concept.
  • Training and communication are an essential element of effective change management and compliance.
  • An aggressive and thorough Internal Assessment program with efficient and competent auditors is your best barometer of the health and adoption of your quality and business processes. Supported by an effective and prudently used Corrective and Preventive action system you can correct and improve system weaknesses and lapses before they result in more serious problems for the business.
  • Communication with your customers during periods of organizational change is essential to assure continued satisfaction and loyalty. This should include increased vigilance concerning customer satisfaction metrics and warranty monitoring.
  • Utilizing the Management Review Meeting and Quality Objectives can provide a valuable framework for defining and tracking the progress for all the moving parts and facets of the change actions. Expectations and approaches should be agile and this meeting structure gets your senior management participating, informed and invested in all the aspects and adjustments to people and process. Companywide meetings for communicating specifics, setting expectations and slaying the insidious “rumor dragons” is crucial in clarifying communication and eliminating harmful distractions.
  • Selection and cultivation of a Registrar that is a positive partner and invested in understanding your business and providing a value-added experience in assessment of your processes and compliance is extremely important. Not all Registrars or auditors understand this expectation and are capable of delivering such a collaborative and mutually beneficial experience.

While extreme periods of change are certainly stressful and can be fraught with risk, it is also a gift of innumerable opportunities to rethink the tried and true and to take a look at every aspect of the business through fresh eyes. I think this can be best summed up in the final conclusion statement by the auditor, “What an exciting and pivotal point in the company history to be a part of this team”.

I have to agree with him; it is pretty darned exciting as an old dog to still be learning new tricks and realizing what a positive experience it can be to rethink established aspects of the business.

 

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Topics: 9001 Software

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