7 IMPLEMENT CHANGES TO THE SHEQ&S PROGRAM
7.3 ADDRESSING NON-CONFORMITIES
There should be a process for addressing and correcting identified nonconformities and systemic gaps. This section discusses how addressing non-conformities is one of the aspects of a quality management system, the different types of non- conformities, the drivers of change that create corrective actions (including reviews that identify non-conformities), and guidance for creating a program that
effectively manages changes required to address the non-conformances. The drivers and corrective actions associated with the process safety system
“management of change” element is described briefly in Sections 7.3.3 and 7.3.4 below, with detailed references available in the literature [CCPS 2007b, CCPS 2008, CCPS 2010, CCPS 2013].
7.3.1 Non-conformance Evaluations are an Aspect of a Quality Management System
Addressing nonconformities is one of the key continuous improvement aspects of quality management system. The aspects, in the context of an effectively designed and implemented SHEQ&S program, include:
Management responsibility - Requires that each SHEQ&S group’s management system is overseen by a manager and that each process safety system, both at the corporate and at the facility level, is overseen by someone. T his individual takes responsibility for initiating and following through to completion any improvement opportunities within their system (i.e., those generated by responses to non-conformities).
Personnel (training) - Ensures that everyone knows how the systems should work, that they know how to identify when it doesn’t work as expected, and provides them with the tools or systems to identify and correct any underlying problems. Process safety investigations focus on identifying and understanding the “root cause” of the failure to meet the expectation or the deviation from the expected result (i.e., the non- conformance).
Product verification - Requires inspection and testing programs to confirm or verify that the “product” meets its expectations, specifications or targets. There are two “products” within the integration effort: 1) the implementation team’s efforts to integrate the independent SHEQ&S management systems into one system; and 2) the expected performance of the metrics and their associated systems that are in place to manage and control the hazardous materials and energies. Non-conformities are identified when the verification fails.
Auditing - The quality system ensures periodic reviews of the system performance and that deficiencies are identified, and that corrective actions to address the deficiencies are created, approved, and tracked until closure. Management reviews are more frequent than audits. B oth the audits and reviews can identify non-conformances.
Use of statistical methods - Requires that the measured system performance be analyzed to identify strengths and the weaknesses. The strengths of the stronger systems can be used as models for improvement;
the deficiencies of the weaker systems will require actions for improvement. Statistical data analysis provides trustworthy non-
conformance information analyses from which people can make effective decisions.
Nonconformance evaluations - Ensures that the root causes of any non- conformances (i.e., the deviations or failures) are identified and corrected, and that corrective actions are created, approved, documented, and tracked until closure. T he tests and inspections have defined specifications and tolerances with which to verify that the “product” is meeting expectations.
In addition to the quality management system aspects noted above, the SHEQ&S program must address compliance issues to demonstrate conformance with regulations and standards. T he periodic management reviews and audits described in Chapter 6 help identify such noncompliance issues, with corrective actions prioritized for prompt resolution. With the SHEQ&S program, these new external requirements can be quickly assessed across all of the groups to leverage potential changes to the other management systems.
7.3.2 The Different Types of Non-conformities
The different types of non-conformities or deficiencies are failure to meet a specification or target within a certain tolerance, failure to conform to compliance standards or industry guidelines, or a breakdown in the work flow within a management system. The SHEQ&S program will be affected by these gaps identified at all levels in the organization. Depending on the organizational level where the non-conformance is identified, different people will need to respond to the non-conformance. T hose at the process unit level address deficiencies identified through the process safety metric data analyses. Those at the facility level address deficiencies in process safety systems based on both the aggregated metrics and the facility system metrics. Those at the corporate level will need to address deficiencies in both the aggregated facility’s process safety system metrics as well as its corporate process safety system metrics.
7.3.3 The Role of Non-conformances in Driving Changes
Non-conformances play a role as drivers for changes to processes handling hazardous materials and energies as well as the systems designed to manage hazards and risks. O ther drivers for both hazardous and non-hazardous process changes include:
New process technologies or operating methods New technologies for existing process equipment
New staffing or organizational changes (includes personnel substitutions and adding to or removing positions)
Corrective actions from deficiencies identified in management reviews and audits, with priority given to regulatory compliance-related and safety performance deficiencies
Corrective actions from incident root cause investigations, both from internally- or externally-shared incidents
Corrective actions from updated hazard and risk assessments
Corrective actions from equipment tests and inspections that fail specific tolerances or criteria
New regulations or industry standards Insurance premium and cost increases
Internal pressure to modify throughputs, improve efficiencies or improve product quality
Internal pressure to reduce organizational costs
These changes range from minor changes in chemicals, technology, equipment, or procedures to large facility expansions or new facilities. The minor changes may be designated as temporary or permanent. S taffing changes may significantly impact process safety performance if they result in insufficient staff or staff with insufficient skills or training. Insufficient staff cannot be expected to operate, maintain, or support the process safety systems at full capacity.
Since each of these drivers for change may have some effect on each group in the SHEQ&S program, an integrated system will be able to make changes in one group and effectively manage the effects of the changes throughout all of the SHEQ&S groups. The SHEQ&S program change management process ensures that changes to one management system are effectively communicated and leveraged across other affected groups.
7.3.4 A Process for Managing Corrective Actions
A process is needed to manage the corrective actions generated by non- conformances. The major sources of continuous improvements on a sustained basis are the corrective actions from scheduled metric measurements, management reviews, and audits. C hanges to management systems occur when incident investigations identify a systemic root cause, as well. Wi thin the SHEQ&S program, the actual process for designing and implementing corrective actions can be shared among those who own the relevant programs, elements, and management processes that are undergoing the change.
The process safety system designed to manage changes, the management of change (MOC) element, provides a p rocess for effectively managing corrective actions. T he corrective actions (and the follow-up measures) are reviewed and authorized before being implemented. Process safety documentation is updated as a part of the implementation step for the change, with formal “pre startup” reviews
performed before the change is implemented. The management of change process identifies who needs to be informed or trained on the change, defines what needs to be communicated (ranging from simple awareness to skills-based training), and helps establish the timing for the change. Specifically, the management of change element interfaces with other process safety systems. The primary interfaces to these systems [CCPS 2007a, CCPS 2010] are:
Process knowledge management Hazard identification and risk analysis Operating procedures
Safe work practices
Asset integrity and reliability Training and performance assurance Operational readiness
These interfaces correspond to many of the quality system groupings previously described in Chapter 5. Hence, the management of change program addresses many of the quality system components included in the SHEQ&S program design.
Since the management of change program is an integral part of managing process safety and is used to identify, review, and approve all changes to process equipment, operating and maintenance procedures, raw materials or processing conditions, it will address changes that may affect the equipment life cycle, as well. The links for the management of change to the equipment’s life cycle were described in Chapter 5, as well. B y designing and using the “management of change” process in the SHEQ&S program, changes affecting process hazards and risks can be effectively leveraged across SHEQ&S groups to help sustain, if not improve, an organization’s process safety performance.