Controlling Changes

Once approved for use, the majority of procedures, work instructions and other implementing documents will invariably require some level of revision during the time frame that they are actively in use. There are numerous factors that come into play that normally require revisions to procedures. Many times changes are identified during the initial implementation of the procedure that are related to the content within the procedure that doesn’t reflect how the actual operations are performed. In other instances, procedural revisions are needed to add steps to adequately address operational safety concerns or regulatory requirements. Other factors that often

TABLE 6.2

Comparison of Approaches for Stakeholder Inclusion

necessitate procedure provisions are changes to operations, evolving safety requirements and changes in regulatory requirements. With such a large percentage of procedures potentially going through revision at some point, it is important that procedural changes are controlled to ensure that only the current approved version is being used. Without a process for procedure change control, companies run the risk of losing version control of procedures, which can result in numerous and outdated versions of a procedure being implemented within the company. It goes without saying that implementing outdated procedures can present increased vulnerabilities to companies in regard to worker safety and health, operational efficiencies and regulatory compliance. A fundamentally sound procedural control program does not have to be overly complex and can be effective by incorporating the following elements at a minimum:

• 1. Procedure title and number
• 2. Page numbers
• 3. Approval date included on procedure
• 4. Effective date included on procedure
• 5. Expiration date included on procedure
• 6. Revision number included on procedure
• 7. Method for notifying personnel of procedure revisions
• 8. Database or another system where employees can access and verify current versions

It is advantageous to include the procedure title, number, approval and effective dates as well as the procedure revision number on each page to preclude any confusion or misinterpretation if the pages become separated during implementation. This may seem like a formality, but there have been more than a couple of instances of procedures being used for operations that actually contained pages from older revisions that had gotten commingled in the current revision of the procedure. Having the revision number and the aforementioned dates in the header or footer of every page provides a simple means to assist in preventing this type of occurrence. These simple elements coupled with a consistent method to notify personnel of procedure revisions and a document control system where employees can readily access current revisions will provide the necessary components for controlling changes to procedures and other documents.

Configuration Management

Not only is it important to control procedural changes to ensure only the most current and correct procedures are being used, but it is also important to understand that other procedures or organizational aspects may be affected by changes to a procedure. As an example, oftentimes environmental compliance procedures include requirements that multiple organizational elements within the company must comply with. As discussed in Chapter 5, ideally these environmental requirements would be flowed down to the organizational elements where they would be incorporated into their organizational procedures. If the environmental compliance procedure is revised, then every procedure or document within the company that has incorporated requirements from the environmental compliance procedure must, at a minimum, be evaluated to determine if similar changes are necessary. Without this type of configuration management, it is fairly easy to understand how quickly procedures and other implementing documents could become disassociated and out of sync with current company or regulatory requirements. To be complete, a configuration management program needs to also consider other operational aspects that could be impacted by procedure changes:

• 1. Training associated with or required by procedure
• 2. Prerequisite actions identified in procedure
• 3. Associated procedures/companion procedures
• 4. Forms
• 5. Checklists
• 6. Diagrams
• 7. Regulatory permits

The complexity of configuration management will obviously increase with the complexity of the organization and the number of procedures and documents being utilized. Instituting an effective configuration management program can be directly associated with the procedure development process and the required content for procedures. Referring back to Figure 6.2, if the template includes required content such as prerequisite actions, required training and referenced procedures and documents, then these aspects all become considerations for configuration management if and when there are changes to the procedure. Configuration management is also where stakeholder participation can play an important role. When stakeholders are involved in the development and review of procedures, the ability to identify potential impacts of procedure changes is greatly enhanced.

Periodic Reviews and Updates

Procedures and implementing documents should undergo periodic reviews to ensure that they are still adequate and information within the procedure is still accurate and relevant. Establishing review and update schedules is an efficient and proactive means for maintaining procedures at all levels of the organization. Procedure review cycles are typically identified in the company document that governs the development, review and approval of procedures (the ‘procedure on procedures’). Without an established schedule for reviewing and updating procedures and other critical documents, a company can create a reactive environment where it can become increasingly difficult to keep up with and track all the needed changes. Quality assurance standards such as ISO 9001, NQA-1 and others recommend that procedures and other implementing documents undergo review and update every three years at a minimum. Many approaches used in industry implement review and update cycles that require an annual review of procedures and implementing documents in conjunction with updates every three years. To further clarify this approach, the annual review requirement is intended to be an evaluation of the procedure to determine if the procedure is still accurate. Annual reviews are commonly a review by the procedure owner or responsible person and are often used to capture administrative-type changes (e.g., contacts, phone numbers), typographical errors, references, etc. The three-year review' and update is intended to be a complete and thorough review of the procedure that includes participation by all the stakeholders. Three-year review's typically involve a much more detailed evaluation of the document and often result in substantial changes. At the completion of a three-year review and update, a procedure is usually issued a new revision number and new approval, effective and expiration dates.

Accessibility of Procedures

Having a set of procedures that are accurate, up-to-date, properly controlled and under robust configuration management w'ill be of minimal value if they are not accessible w'ithin the organization. The accessibility of procedures is paramount for every aspect regarding procedure and document management. Ready accessibility is commonly made possible through the utilization of electronic storage and management of documents using databases or other document management software. Obviously, procedures need to be available to those responsible for implementing the procedures within their organizations and areas of responsibility. As previously discussed in Section 6.3.3, having procedures readily accessible allows for users to verify that they are using the most current and correct version of the procedure. With the technology today, there is ample opportunity to utilize handheld electronic devices to access electronically stored procedures in the field, w'hich can add a great deal of efficiency to procedure use and control. However, there are many operations in the field w'here handheld devices are not practical or allow'ed and hard copies of procedures are needed during operations. Ready access to current procedures allows for this simple verification to take place prior to the commencement of operations. Procedure accessibility is not only important to the end user, it is also critical to internal stakeholders, procedure owners, administrative personnel, managers, training personnel, safety personnel, etc. Ideally the entire organization should have access to all procedures. There are of course exceptions to this w'hen procedures involve sensitive, proprietary or classified information. In these cases, access obviously has to be restricted to the appropriate audiences, but how'ever limited the audience, the information still has to be accessible for all of the same reasons mentioned above.

Applied Learning

• 1. Discuss the difference between corporate- and organizational-level procedures.
• 2. Discuss w'hy having a ‘procedure for procedures’ is important.
• 3. What are the important elements that should be included in a ‘procedure for procedures’?
• 4. Discuss the consequences that can result from the inadequate management of procedures and implementing documents.