Procedure – Established Method of Operation

What is a Procedure?

A procedure is a formally documented, structured sequence of instructions that guides how a specific task or process should be performed to achieve predictable and compliant outcomes. Procedures are the backbone of operational discipline, especially in highly regulated sectors such as aviation, healthcare, manufacturing, and IT.

In these environments, procedures are meticulously crafted to ensure that every step—no matter how routine or complex—is executed correctly and safely. This not only enables organizations to meet regulatory requirements but also minimizes human error, supports training, and enhances overall quality and efficiency.

Procedures are not optional or suggestive guidelines. They are enforceable requirements, often subject to audits and legal scrutiny. Deviation from a procedure is only permitted when authorized, such as in abnormal or emergency situations, and such deviations are typically documented for review.

Established Method of Operation

The concept of an established method of operation is central to high-reliability organizations. It means that tasks are performed in a uniform, codified manner every time, leaving little room for ambiguity or improvisation.

For example, in aviation, ICAO Annex 6 mandates that every operator maintain an operations manual containing all normal and emergency procedures, which must be followed by flight crews and ground staff. These procedures are reviewed and approved by regulatory authorities, and their use is enforced through training, audits, and recurrent assessments.

Standardization through procedures ensures:

• Consistency: Tasks are always performed the same way, regardless of who is executing them.
• Safety: Risks are anticipated and mitigated through documented steps and controls.
• Compliance: Procedures integrate legal and regulatory requirements.
• Transferability: Best practices are shared and replicated across teams and locations.

Why Are Procedures Important?

Procedures underpin the safe, efficient, and compliant functioning of organizations. Their benefits include:

• Standardization: They ensure everyone performs tasks the same way, reducing variability and supporting quality.
• Quality Assurance: Procedures define checkpoints and acceptance criteria, forming the core of quality management systems.
• Risk Reduction: By anticipating failure points and embedding controls, procedures minimize the likelihood and impact of human error.
• Regulatory Compliance: Auditable procedures are often legally required, demonstrating adherence to laws and standards.
• Training: Procedures accelerate onboarding and skills transfer by providing clear, actionable instructions.
• Auditability: Documented procedures create a record for internal and external audits, incident investigations, and continuous improvement.
• Crisis Management: In emergencies, quick reference to procedures ensures swift, coordinated responses.

Key Terms in Procedure Management

Structure and Components of a Procedure

A well-designed procedure is clear, concise, and logically organized. Key sections typically include:

• Title and Header: Procedure name, unique identifier, version, keywords.
• Purpose: The objective and rationale.
• Scope: Applicability—who, what, where, and when.
• References: Regulations, standards, or related documents.
• Definitions: Clarification of technical terms and acronyms.
• Roles and Responsibilities: Who does what at each stage.
• Detailed Instructions: Sequential steps, decision points, and verification.
• Resources/Tools: Equipment or materials needed.
• Safety and Compliance: Required controls and hazard information.
• Troubleshooting/Contingency: Guidance for common issues or deviations.
• Appendices/Visuals: Checklists, flowcharts, diagrams.
• Revision History: Records of updates and approvals.
• Approval Signatures: Authorization and accountability.

This structure ensures comprehensiveness, user-friendliness, and enforceability, as recommended by standards like ISO 9001 and ICAO documentation.

Types of Procedures

1. Standard Operating Procedures (SOPs)

SOPs provide clear, step-by-step instructions for routine or repetitive tasks. They are optimized for consistency, safety, and efficiency, and are often supported by checklists or digital tools.

Example SOP Applications:

• Flight crew pre-flight checks
• Equipment inspection in manufacturing
• Medication administration in healthcare

2. Method of Procedure (MOP)

MOPs are used for complex, non-routine, or high-risk tasks that require coordination across teams and detailed verification.

Example MOP Applications:

• Aircraft engine overhaul
• Data center server migrations
• Commissioning of new production lines

3. Emergency Operating Procedures (EOP)

EOPs outline immediate actions for abnormal or crisis events, using explicit, direct language to facilitate rapid response.

Example EOP Applications:

• Engine failure response in aviation
• Medical emergency response in hospitals
• Disaster recovery in IT

Procedures Across Industries

Aviation:
Procedures govern every aspect, from flight operations to maintenance and air traffic control, as mandated by ICAO, EASA, and FAA.

Healthcare:
Procedures standardize patient care, medication handling, and emergency response, ensuring patient safety and regulatory compliance.

Manufacturing:
Procedures control equipment operation, maintenance, quality inspections, and response to incidents.

IT/Data Centers:
Procedures manage system upgrades, backups, security updates, and disaster recovery.

Hospitality:
Procedures ensure consistency in service delivery, food safety, and emergency evacuation.

Best Practices for Procedure Development and Maintenance

• User Involvement: Engage those who will use the procedure in its design and testing.
• Clarity: Use simple, direct language; define any technical terms.
• Logical Flow: Sequence steps logically, using lists and diagrams where helpful.
• Clear Roles: Specify who is responsible for each step or decision.
• Safety & Compliance: Integrate relevant safety measures and regulatory references.
• Validation: Test procedures in realistic scenarios before rollout.
• Version Control: Track updates and ensure only the latest version is in use.
• Training: Provide accessible training and reference materials.
• Regular Review: Update procedures after audits, incidents, or regulatory changes.

Procedure Templates & Examples

Manufacturing SOP Example

Title: Daily CNC Machine Startup
Purpose: Safe, optimal machine startup
Scope: Production Line 2 operators
Steps:

1. Inspect fluids
2. Check guards
3. Power on in sequence
4. Warm up spindle
5. Log completion

IT MOP Example

Title: Server Migration
Objective: Minimize downtime
Steps:

1. Notify stakeholders
2. Backup systems
3. Shut down and move servers
4. Power up and test
5. Log results

Healthcare EOP Example

Title: Code Blue (Cardiac Arrest)
Scope: ICU staff
Steps:

1. Alert response team
2. Start CPR
3. Use defibrillator
4. Administer meds
5. Document actions

Troubleshooting and Contingency Planning

Effective procedures include troubleshooting sections that help users resolve common problems and specify escalation contacts for unresolved issues. For example, if a maintenance step fails, the procedure may direct the user to verify connections or escalate to engineering support.

Pitfalls in Procedure Development

• Ambiguity: Vague instructions lead to errors.
• Outdated Documents: Procedures must be updated after any process or regulatory change.
• Lack of User Input: Users must be involved to ensure practicality.
• Incomplete Steps: Every action, check, and decision must be documented.
• Ignoring Compliance/Safety: Omitting legal or safety requirements increases risk.

Regulatory Requirements

Organizations such as ICAO, EASA, and FAA mandate the creation and maintenance of procedures for all critical operations. Procedures must be:

• Clear, concise, and usable under operational conditions
• Integrated into training and quality management systems
• Regularly reviewed and auditable

Procedures in Safety Management Systems (SMS)

Procedures are integral to the hazard identification, risk assessment, emergency response, and continuous improvement elements of an SMS. They provide the structure for safe operations and document lessons learned for future improvement.

Digitalization of Procedures

Modern organizations deploy procedures via digital platforms—mobile apps, electronic flight bags, workflow management tools, and intranet portals. Digital procedures offer real-time access, automated version control, built-in checklists, and usage analytics, increasing compliance and reducing errors.

Summary

A procedure is more than a set of instructions—it’s a critical control for safety, quality, compliance, and efficiency across industries. Well-designed, regularly updated procedures enable organizations to deliver reliable, safe, and legally compliant operations, even in the most complex and regulated environments.