ECSI Blog

The scientists and staff at Argonne National Laboratories (ANL) in Lamont, Illinois, fondly refer to their primary product, the Advanced Proton Source as “The Beam”.  Argonne National Laboratory is one of the U.S. Department of Energy’s largest research centers. It is also the nation’s first national laboratory, chartered in 1946.  The laboratory has about 2,800 employees, including about 1,000 scientists and engineers, of whom about 750 hold doctor degrees. Argonne’s annual operating budget of about $530 million supports upwards of 200 research projects, ranging from studies of the atomic nucleus to global climate change research. Since 1990, Argonne has worked with more than 600 companies and numerous federal agencies and other organizations.

 About ANL and the Audit Project

 ECSI was asked to assist ANL in its efforts to implement and certify an ISO 14001 Environmental Management System.   In January 2009 we performed a week long complete management system internal audit at ANL, their first, as they prepared for the registration process scheduled to begin in the early spring of 2009.  The objective of the audit was three-fold:

 Complete an internal audit meeting the requirements of section 4.5.5 of ISO 14001;

Introduce the ANL staff to the audit process and help prepare them for the registration audits;

Provide additional training and answer any questions any of the divisions audited had.

The immense scale of ANL presented special technical and logistic challenges to the audit team. The facility includes hundreds of buildings and covers over 1500 wooded acres.  This complexity required use of a focused vertical approach to the audit process which drilled deeply into very specific areas of the EMS.  

 Vertical EMS Auditing

 ISO 14001 audits can be performed using two basic auditing techniques, vertical auditing and horizontal audit.  Horizontal audits cover the EMS broadly and are often done on a clause-by-clause basis.  Gap analysis and Stage 1 registration audits are examples of horizontal audits.  One way to characterize horizontal audits is they are a mile wide but only an inch deep.  In contrast, vertical audits are much focused and follow an audit trail through the EMS to the verification of a detailed requirement. These audits are an inch wide but a mile deep.  Stage 2 registration audits are examples of vertical audits.  

 Audits can use both vertical and horizontal audit techniques to meet the objectives of the audit.  The concentrated time line for the ANL internal audit project required efficient use of the vertical audit approach to accomplish the audit objectives.

 ANL Biosciences Division

 The Biosciences Division is a large laboratory conducting research in many biological areas.  The time allocated to conduct the audit here was 3 hours.  Part of the challenge of auditing complex facilities is to quickly understand the processes being operated at the audit location.  Once the process is clearly understood the auditor can identify potential audit trails to follow.  

 The approach used to audit this division was to first determine what research projects were being conducted at the time of the audit.  Many projects are conducted simultaneously so the challenge is to quickly identify one that has potential to produce evidence of conformance to the EMS.

 The research project selected involved the production of specific proteins from genetically engineered bacteria.  Genetic material is inserted in the bacteria which are then cultured to produce sufficient quantities of the special protein.  The protein is then isolated and crystallized for further analysis at the ANL Advance Proton Source “The Beam”.  

 Bio-hazard wastes like Petri dishes and culture media are produced during the process and need to be sterilized prior to removal from the lab for disposal.  The audit trail followed this specific process gathering evidence of effective operational controls for the autoclaves used to sterilize this waste.  Evidence of training and competence of the autoclave operators’ and evidence of calibration of the instrumentation used to monitor the autoclave performance were also investigated.

 Center for Nanoscale Materials

 The Center for Nanoscale Materials (CNM) is another laboratory where research is performed on very small samples, at the molecular level.  Of the many research projects performed at the lab, one immediately stood out as a potential audit trail.  It involved research of an electroplating process on micro wires and was being conducted by a researcher in the chemistry department from the university I attend and received my BS (UW Stevens Point).

 Before an experiment can be approved to be conducted at the CMN, the researcher must submit an application that identifies the potential environmental impacts and health and safety risks associated with the work that will be performed at the lab.  The application is then reviewed by the CNM management and operational controls are identified which must be followed by the research team during the project.

One of the materials to be used during the research was acetone.  The audit trail chosen was to collect evidence that the lab had identified the operational controls needed to manage waste acetone properly.  This included investigating the details of the documented acetone waste management procedure and the evidence of training of the researchers in this procedure.

 Optimally, the audit would have concluded with observation that the acetone waste management was actually being followed as prescribed in the documented procedure.  Unfortunately, the research for this project was being performed in a highly controlled clean environment and the audit schedule did not allow sufficient time for the auditors to get suited up and enter the lab to observe that acetone waste was being managed according to the documented procedure.  But that’s okay because the amount of evidence that can be obtained during an audit is a function of time allowed to perform the audit.  The audit planning process strives to predict the amount of time needed to complete the audit but sometimes the effort required is unintentionally underestimated.

 The Beam

The Advance Proton Source (aka “The Beam”) provides this nation’s (in fact, this hemisphere’s) most brilliant x-ray beams for research in almost all scientific disciplines.  The beam itself is generated in a circular particle accelerator with a circumference of approximately 1 mile.  Positively charged electrons (photons) are accelerated to almost the speed of light using a series of strong electromagnets.  Researchers (up to 200 teams at any give time) positioned around the outside of the beam, tap into this x-ray source to perform measurements on their particular research projects.

 The support processes to operate and maintain the beam are enormous.  As an example, the beam requires large amount of electrical energy and the magnets using this energy generate significant amounts of heat.  This heat is removed by recirculation of cooling water that is conditioned by chillers using many thousands of pounds of refrigerants.  The operation and maintenance of these chillers was chosen as an audit trail but was only one of many audit trails that could have been followed at The Beam.  

 One of the highlights of the project was on this audit trail which allowed the audit team to actually enter the internal workings of the accelerator during a maintenance period.  Maintenance requiring The Beam to be down is infrequent and this opportunity allowed auditing of processes that would normally be prohibited during operation due to the the strong radiation generated in these areas.

 Limitations of Highly Vertical Auditing

 Vertical auditing is a great way to probe deeply into an EMS.  However, it relies on a sampling approach that is very focused.  To get the depth required in this type of audit, the audit team usually has time to investigate only a few very specific areas.  This approach can diminish the reliability which can be placed on the audit findings and the subsequent audit team conclusions.  It is possible that the specific areas selected were not representative of the overall conditions.  Fortunately or unfortunately, depending on your perspective, good auditors have an uncanny ability to select that one audit trail that results in discovery of a potential nonconformance in the midst of complete conformance in all other areas.  

 If the duration of an audit is sufficient, a combination of vertical and horizontal audit techniques allows the audit team to cover a broader spectrum of activities and areas and can result in a high level of confidence in the audit conclusions.  

 Optimizing the costs and benefits of audits depends on the skillful use of both vertical and horizontal auditing techniques and when applied properly, will result as was seen in the ANL EMS audit project, in achieving the audit objective in a cost-effective manner.