When to Use Specific Quality Management Forms: A Guide to Effective Quality Control
When to Use Specific Quality Management Forms: A Guide to Effective Quality Control
In a quality management system (QMS), using the right form at the right time is essential for ensuring compliance, improving processes, and maintaining high product quality. However, one of the biggest challenges businesses face is knowing which form to use and when—leading to inefficiencies, redundant paperwork, and compliance risks.
This guide provides a detailed breakdown of common quality management forms, explaining their purpose, when they should be used, and specific criteria for issuance.
1. Nonconformance Report (NCR) – Tracking Defects & Process Failures
What is an NCR?
A Nonconformance Report (NCR) is a report used to identify, record, and track deviations from established standards, specifications, or requirements. It ensures that defects and nonconforming conditions are documented, reviewed, and corrected.
To ensure consistency, it’s wise to establish clear thresholds for when an NCR should be issued. Common examples include:
- If scrapped material exceeds $150 in value.
- If more than 1 hour of rework is required.
- If a nonconformance is identified at final inspection.
- If a customer identifies an issue.
- If a defect is discovered during an audit.
By setting defined criteria, companies prevent over-documentation of minor issues while ensuring serious problems are properly tracked and addressed.
When to Use an NCR
- When a product, part, or process does not conform to specifications.
- When defects are identified during inspections, audits, or production.
- When customer complaints indicate a quality issue.
- When rework or material scrap exceeds predetermined cost or time limits.
2. Corrective Action & Preventive Action (CAPA) – Root Cause & Prevention
What is a CAPA?
A Corrective Action & Preventive Action (CAPA) is used to eliminate the root cause of a problem and prevent future occurrences.
A corrective action is taken in response to a known nonconformance, whereas a preventive action is issued to address a potential risk before it becomes a problem. Both use the same form and process.
Key components of a CAPA:
- Immediate Containment – Quick actions to prevent further issues.
- Root Cause Analysis – Identifying why the problem occurred.
- Corrective Action Plan – Steps to prevent recurrence.
- Verification of Effectiveness – Ensuring the action was successful.
When to Use a CAPA
- If a recurring issue is found, indicating a systemic problem.
- If a customer complaint reveals a serious defect.
- If an audit finds a major nonconformity.
- If a regulatory compliance issue is identified.
3. Management of Change (MOC) – Controlling Process Changes
What is an MOC?
A Management of Change (MOC) is used when planned changes could impact product quality, safety, or compliance. MOCs help evaluate risks before changes are implemented.
Examples of changes that require an MOC:
- Switching suppliers or materials.
- Modifying a production process.
- Introducing new machinery or software.
- Changing work instructions or procedures.
- Adjusting training requirements for employees.
When to Use an MOC
- When a planned change may impact quality, safety, or efficiency.
- When updating procedures, processes, or equipment.
- When new compliance requirements must be integrated.
4. Engineering Change Notification (ECN) – Managing Design Changes
What is an ECN?
An Engineering Change Notification (ECN) is used for modifications to design specifications, drawings, or product configurations. ECNs are essential in industries with heavy engineering and technical processes.
When to Use an ECN
- If a design needs modification due to errors, efficiency improvements, or material changes.
- If customer requirements change, requiring updates to drawings or specifications.
- If a product’s safety or compliance needs revision.
5. Customer Communication Log (CCL) – Tracking Customer Interactions
What is a Customer Communication Log?
A Customer Communication Log (CCL) tracks customer feedback and interactions that may later lead to quality improvements.
If a CCL entry is made, an NCR or CAPA must also be issued as appropriate.
When to Use a Customer Communication Log
- To document customer concerns that don’t immediately require an NCR.
- To track informal feedback for future trend analysis.
- To record general questions or requests.
6. Approved Supplier List (ASL) – Ensuring Supplier Compliance
What is an Approved Supplier List?
The Approved Supplier List (ASL) tracks key vendors whose performance affects product quality.
When to Use the Approved Supplier List
- To evaluate suppliers based on risk, performance, and compliance.
- To log audit results and certifications.
- To monitor vendor quality over time.
7. Risk Register – Managing Strategic Risks
What is a Risk Register?
A Risk Register tracks major risks to quality, compliance, and business operations.
Depending on company policy, the Risk Register may be updated annually based on CAPAs issued in the past year.
When to Use a Risk Register
- To identify and monitor legal, operational, and strategic risks.
- To document preventive actions for potential hazards.
8. Competence & Training Records – Managing Workforce Skills
What is a Competence & Training Record?
These records track employee training, certifications, and required qualifications.
When to Use Competence & Training Records
- To assign job-specific training.
- To ensure regulatory compliance.
- To track ongoing skill development.
Choosing the Right Form for Quality Management
Using the correct quality form at the right time ensures process efficiency, regulatory compliance, and continuous improvement.
For a simplified way to manage NCRs, CAPAs, supplier evaluations, and training, check out TQA Cloud QMS Software—designed to streamline your quality documentation process.
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