Procedure Lifecycle

We write and use procedures to help the user complete the task successfully and avoid undesired outcomes. Well-written procedures are an integral part of any organization for operation, managing risks, and continuous improvement. Effective procedures are important for the transfer of knowledge from the engineers/architects of the system to the users of the system.

Good procedures, and we are not talking format so this can be paper documents to a mixed reality guide, provide these four categories of information:

1. Goal: The goal presented to the user as a state to be realized. This can be an end state or an intermediate state of the overall system.
2. Prerequisites: The condition for moving toward the desired state or goal. These are the conditions that must be satisfied so that the user can achieve the goal.
3. Actions and reactions: These states are reached through actions of the user and the reactions of the system. They may have milestones or sub-goals. It involves the description of (a series of) action steps.
4. Unwanted: These are the states to be avoided (e.g., errors, malfunctions, injuries). It provides guidelines on what to avoid for successful and safe execution of procedure and may include warning, caution, or instruction for solving a potential problem.

Procedures have a lifecycle through which they are developed, administered, used, reviewed, and updated. In the post “Document Management” I discussed the document management lifecycle.

I want to focus specifically on procedures by covering five distinct phases: procedure plan, design and development, procedure authorization, procedure administration, procedure implementation and use, and procedure review and maintenance.

Phase	Includes	Document Management Steps
Procedure plan, design and development	Identifying whether a procedure is necessary; collecting required information; producing instructions and information on the work, regulatory compliance, process and personnel safety; a walkthrough to ensure quality and potential compliance of the procedure	“New SOP is needed”   Drafting
Procedure Authorization	Procedure review; publishing the final document; revision control; the approval process.	Review Approval
Procedure Administration	Managing procedure repository, control, and deployment; identifying administers how, when, and to whom procedures are to be delivered.
Procedure Implementation and Use	Procedure is used in operations
Procedure review and maintenance	Periodic review of documents, as well as updates from the CAPA and Change Management processes	Periodic Review

References

• Procedure Professionals Association (PPA), 2016. Procedure Process Description. (PPA AP-907-001)
• Van der Meij, H., Gellevij, M., 2004. The four components of a procedure. IEEE Trans. Prof. Commun. 47 (1), 5–14