Section 4

SECTION 4 —MONITORING AND MEASUREMENT

4.1 EMS PROCEDURE FOR TRACKING ENVIRONMENTAL PERFORMANCE

Purpose

The purpose of this procedure is to allow R6 Lab monitors and measures the aspects that can have a significant impact on the environment, to assess the effectiveness of its operational controls, and to track its progress towards achieving environmental objectives and targets. Primarily the Building Engineer and EMS Coordinator conduct monitoring and measuring of operations and activities relative to significant aspects with assistance from on-site contractors and other staff.

Procedure

The procedures followed are documented in written work assignments to staff and contractors. The records associated with monitoring and measuring as well as the calibration of monitoring equipment are specified on the EMPs & OCs and are maintained in the files of the EMS Coordinator. Need to verify that monitoring and measuring is included in the EMPs & OCs.

The following steps describe the procedure used to establish performance metrics for the R6 Lab:

1. The EMS Team examines the significant environmental aspects and identifies the key characteristics of each. To identify these characteristics and understand how they can be monitored the EMS Team may consult with subject matter experts or those whose work directly interacts with the significant aspect. The key characteristics will include indicators of operational control effectiveness as well as effectiveness in reaching established environmental objectives and targets.
2. For each significant aspect, the EMS Team establishes methods for monitoring the key characteristics. To develop the methods, the EMS Team may consult with subject matter experts or those whose work directly interacts with the significant aspect. The methods will identify any necessary equipment, describe the data to be collected, identify individuals with responsibilities for helping monitor the aspect, and establish the frequency of data collection and the frequency, format, and recipient(s) of any reporting.

4.2 NON-CONFORMANCE, CORRECTIVE AND PREVENTATIVE ACTIONS

Purpose

The purpose of this procedure is to define responsibility and authority for handling and investigating EMS nonconformance’s, for taking action to mitigate any impacts caused by EMS nonconformance, for initiating and completing corrective and preventive action, and for reporting trends in nonconformance to management during management review.

Definitions

EMS nonconformance: Any non-conformance with written in the R6 Lab EMS Manual, Policy, Environmental Management Programs and Operational Controls.

Procedure

In general, actual competencies are tested against required knowledge, skills, and abilities when an individual is hired for a given job. To the extent necessary, competencies are further developed through formal training and/or on-the-job training. By hiring competent staff and contractors EMS systems will reduce non-conformance of EMS objectives and targets. EMS members shall implement corrective and preventative actions while tracking and implementing their EMS.

The results of checks of the EMS are used to ensure that controls are operating properly and the EMS is functioning and continually improving. When nonconformances are detected, the EMS Coordinator initiates corrective action. Procedure should authorize all employees to report nonconformances or suspected nonconformances. When the EMS Coordinator detects the need for corrective action, he initiates and documents the corrective action using work assignments, written procedures, workgroup meetings and/or training. The Management and EMS Coordinator are responsible for coordinating completion of agreed corrective actions within their organizations.

Preventive actions are documented in each EMP. Examples of preventive actions include regular inspections, maintenance of monitoring equipment, and environmental audits.

All employees are authorized and required to report any suspected nonconformance in the EMS to the EMS Coordinator. Reporting of suspected nonconformance may be done by e-mail, phone call, conversation, or letter.

Although employees are encouraged to identify themselves when reporting suspected nonconformance (to assist in verifying evidence), employees may also report suspected nonconformance anonymously via Suggestions Box.

The EMS coordinator records information about the suspected nonconformance.

The EMS Coordinator may investigate the suspected nonconformance or assign the task of investigation to someone else (e.g., a member of the internal auditing team).

The investigator will take actions necessary to:

• Determine the circumstances surrounding the suspected nonconformance
• Evaluate the scope and severity of the nonconformance
• Assess any implications (environmental or otherwise) of the nonconformance
• Initiate any immediate response necessary
• Determine the root cause
• Decide on any corrective actions that need to be taken.

For determination of necessary corrective action, the investigator may consult with others including the EMS Coordinator, EMS Teams, EMS Internal Audit Team, or Management.

All recommended corrective action is subject to verification by the EMS Coordinator or his/her designee.

Copies of all supporting information collected during a nonconformance investigation are kept on file by the EMS Coordinator.

Serious procedural gaps, evidence of systemic nonconformance, or other findings suggesting major deficiencies in the EMS as a whole are brought to the immediate attention of the EMS Coordinator. The EMS Coordinator investigates such findings and, in consultation with the EMS Teams, the Internal Audit Team to prepares a report to the management. The report includes recommendations for corrective actions and any other action that may be warranted. Corrective actions that may require significant resource allocations include an estimate of the type and amount of resources required.

4.3 INTERNAL EMS AUDITS

Purpose

The purpose of this procedure is to establish a process for periodically determining whether the EMS conforms to planned arrangements for environmental management. The EMS audit determines whether the EMS has been properly designed, implemented, maintained, and is functional.

If compliance data is examined, it is for the purpose of verifying that the environmental programs are sufficient to achieve compliance with legal requirements.

Systems audits are used to ensure conformance to ISO 14001 and to identify continual improvement. Two types of EMS audits are conducted at the R6 Lab: internal and external third-party audits.

Procedure

4.3.1 Audit Team and Team Lead

As part of the EMS implementation, R6 Lab established an Internal EMS Audit Team. The internal EMS audits are led by the Audit Team Lead, who is recommended by the EMS Coordinator and is approved by the management.

The Audit Team Lead is supported by a team of qualified personnel from various parts of the R6 Lab. The Audit Team Lead is responsible for recruiting Audit Team members, who must then be approved by the EMS Management. To assure objectivity, the Audit Team should not include personnel directly responsible for the area(s) being audited.

Audit Team members should have formal training in EMS auditing, or possess specific skills or knowledge of pertinent technical issues, regulations, management systems, and/or facility processes and products.

Auditor orientation should include the followings:

• Review of the relevant ISO 14001
• Defining of the auditor(s) role, responsibilities, and auditing techniques
• Determining the scope of the audit and review of relevant documents and procedures
• The method of documenting the audit and nonconformance

Training may be accomplished through either:

• The successful completion of an internal auditing course or lead auditor course by a recognized third party
• Internal auditor training provided by personnel who have successfully completed an internal auditor or lead auditor training course

4.3.2 Audit Plan

The EMS Audit Team develops an overall audit plan which should cover the following elements:

• The specific areas, functions, procedures, and activities to be audited
• Personnel qualified to perform the audits
• Audit schedule, duration, and frequency
• Audit processes and techniques

4.3.3 Audit Schedule and Frequency

An audit schedule is developed by the audit team via an audit plan.

The audit frequency is based on the status and importance of the elements in the EMS manual, as determined by:

• Significant Environmental Aspects or risks and hazards
• Concerns raised by interested parties
• Results of third party and internal audits
• Concerns raised during Management Reviews

All EMS elements should be audited a minimum of once annually.

4.3.4 Audit Process

The Audit Team Leader is responsible for:

• Assigning audit responsibilities to the audit team members
• Developing the audit plan
• Conducting audit team meetings
• Resolving differences of opinion among audit team members
• Maintaining communications with the auditee(s) throughout the audit
• Preparing the final audit report
• Communicating the findings of the audit report to Management or EMS Coordinator

The EMS audit is conducted primarily through the review of records, observations of operations, and interviews with personnel. EMS audits may involve sampling compliance data to ascertain whether compliance programs are achieving their intended objectives.

Interviews are conducted in the employee’s normal work area, if possible, so that actual processes can be observed and any records or related data are available for review.

Upon completion of the audit, the audit team meets with relevant management and EMS Coordinator to advise them of the audit results.

4.3.5 Audit Findings

EMS audit findings are based on objective evidence that is properly corroborated and authenticated. Audit findings are not based on hearsay or opinions.

Each audit team member is responsible for obtaining an objective review of his/her audit findings from another audit team member. The goal is to ascertain whether another independent auditor comes to the same conclusions when presented with the facts.

All final findings must represent the consensus opinion of the entire Audit Team.

4.3.6 Audit Reporting

The Internal EMS Audit Team submits completed audit documents to the Audit Team Lead, who prepares the Final Audit Report. The Final Audit Report may include the followings:

• Introduction and scope, describing what was covered in the audit
• Description of areas reviewed and related activities
• Assessment date(s)
• Audit team members and areas of responsibility
• Individuals interviewed and respective areas of responsibility
• Audit findings/Recommendations

The final Audit Report is submitted by the EMS Coordinator to the lab management for appropriate action according to Management Review.

4.3.7 Corrective Action

The Audit Team conducts the audit and submits a written report. The EMS Coordinator works with the Team Leads and Management for consideration of findings and implementation decisions and presents the corrective action responses.

The EMS Teams reviews the report and provides comments to the Team Leads to construct a corrective action response, which includes recommendations and resource estimates for corrective actions. It is the responsibility of the EMS Coordinator, the EMS Team Leads and Management to ensure that needed corrective actions are completed in a timely manner.

All audit plans, audit reports and corrective action plans are retained as EMS records.

4.4 EMS MANAGEMENT REVIEW

Purpose

The R6 Lab Management at least twice per year conducts a planned formal review of the EMS to ensuring the effectiveness, suitability, adequacy and continual improvement. During this review the EMS Coordinator and the EMS Teams provide the management with information on performance of the EMS.

Procedure

Management will conduct an annual EMS review. The EMS Coordinator will prepare the necessary input to be considered in the review. Items to be included in the information presented may include the following:

• EMS Audit results
• Monitoring and measurement of environmental indicators
• Achievement of objectives and targets in the EMS
• Regulatory compliance status
• Correction and prevention of non-conformances in the EMS
• Any other relevant information on the EMS.

Upon review of the above information, management shall make a determination on the continuing effectiveness of the EMS implementation, specifically on the ability to achieve the objectives and targets. Management will also consider whether the system continues to be adequate and suitable for its intended purpose.