Quality Management Systems: Traceability, Audits, and Key Processes

Quality Management Systems

Traceability

Traceability is the ability to trace the history, application, and location of what is under consideration. It serves to:

• Find where a product is.
• Identify the materials used in the manufacture of a product.
• Demonstrate the performance of planned inspections and tests.
• Find the causes of nonconformities.

Compulsory Procedures

Document Control

A documented procedure defining the controls needed to approve, revise, and update documentation when necessary. Documents must be legible and readily identifiable, ensure that changes are identified, and prevent the use of obsolete documents.

Control Records

A documented procedure defining the controls required to identify, store, protect, retrieve, retain, and dispose of records.

Internal Audits

Necessary to determine whether the QMS conforms to planned arrangements, with the requirements of international standards and the requirements of the organization, and if it is carried out and maintained effectively.

Control of Nonconforming Product

Take actions to eliminate nonconformities; allow the use, release, or acceptance under concession by relevant authority; take action to prevent its original intended use or application.

Corrective Actions

Reviewing nonconformities, determine the cause of nonconformities, ensure they do not re-occur, identify actions needed, and the results of actions taken.

Preventive Actions

Identifying potential nonconformities and their causes, evaluate the need for action to prevent the occurrence of nonconformities.

Steps for an Audit

Preparation

• Contact the auditor.
• Develop an audit plan.
• Review documentation.
• Develop a plan-checklist.

Development

Verifies that the QMS complies with ISO 9000 or as applied, and that the company complies with the provisions of the documentation, maintaining or improving the product or service.

Closing/Monitoring

Final meeting to close the audit, reporting non-conformances, needed observations, and conclusions.

Responsibilities for Quality

• Ensure to establish, implement, and maintain the necessary processes for the QMS.
• Report to management on the performance of the QMS and any need for improvement.
• Ensure the promotion of awareness of customer requirements at all levels of the organization.

Main Phases of Design

• Planning design and development.
• Preparation of design and development input.
• Results of design and development.
• Revision of the design and development.
• Verification of design and development.
• Validation of the design and development.

Indicators

They are defined as key business activities that are chosen for their relevance as benchmarks for evaluating the effectiveness of a continuous improvement program. They serve to:

• Establish improvement targets.
• Develop plans of action.
• Assess the improvements.
• Compare results with objectives.
• Establish new goals.

Document Control

The process ensures that all QMS documents are available and accessible to all staff who have to use them. Documentation must be dated, reviewed, and approved by the persons responsible. They must also be updated, reflecting the way of carrying out the review and change situations.

There should be a documented procedure defining the controls for:

• Approving documents regarding adequacy prior to issue.
• Reviewing and updating documents as necessary and re-approving.
• Ensuring that changes are identified and the state of the current version.

PDCA Cycle

Improvement cycle developed by Deming in 1920, which is characterized by 4 steps:

• P (Plan): Plan. Establish plans.
• D (Do): Make. Carrying out the plans.
• C (Check): Check if the results match what was planned.
• A (Act): Act to correct problems found.

Accreditation

Accreditation is the internationally established tool to build trust in the performance of a very specific type of organizations that generally are called Bodies and Conformity Assessment covering Test Laboratories, Calibration Laboratories, Inspection Bodies, certification bodies, and environmental audits.

Certification

Certification is the action carried out by an independent organization recognized as stakeholders, which is manifested by the compliance of a company, product, process, service, or person with the requirements defined in standards or technical specifications.