Essential Elements of a Robust Quality Management System

Forms and Records Management

  • Date
  • ID (who fills in the document)
  • Readable
  • Understandable

Top Management Responsibilities

Top management is responsible for making decisions and allocating resources (economic).

Key Management Tools

  1. Quality Policy
  2. Quality Objectives
  3. Management Review

1. Quality Policy

A document of the quality system that includes commitments from top management, signed by top management.

Policy Requirements:

  • Commitment to continuous improvement.
  • Commitment to customer satisfaction.
  • Provides the framework for objectives (long-term).
  • Ratified by senior management (senior management of the company agrees with continuous improvement).

2. Quality Objectives

Planned improvement actions.

Requirements:

  • Achievable
  • Measurable
  • Consistent with the policies and planning
  • Goal: Halfway point to achieve an objective.
  • Action: What is needed to carry out an objective (tools, people, etc.).
  • Responsible Party: The individual or team ensuring the action is carried out.
  • Time: The timeframe within which this action must be completed (a longer period than the action itself).

3. Management Review

A review of the quality management system’s performance. Decisions are made based on results.

Characteristics and Requirements of the Standard:

  1. Conducted at least once a year.
  2. What is taken into account:
  • Results of audits.
  • Whether objectives and targets are satisfied.
  • Nonconformities and corrective/preventive actions.

Purchasing and Supplier Management

1. Purchasing Requirements

  • Product
  • Outsourcing

2. Standard Requirements for Purchasing

  1. Define requirements for purchased material or product (suppliers must meet these).
  2. Classify suppliers (identify preferred suppliers).

Material Requirements (Controls)

  • Documentary Check: Verify the order against the delivery note.
  • Visual Inspection/Detailed Review: Analyze in detail if the product meets the requirements and order.

Classify Suppliers

  • Evaluate only those suppliers whose products or services affect the quality of your own service.

Supplier Evaluation Considerations

  • Criteria: Price, punctuality, availability, technical characteristics, reliability, planning. (Factors to consider when choosing suppliers).
  • The standard requires an evaluation method but does not define a specific one.
  • Assess suppliers by specific areas or categories.
  • Every company should establish its own evaluation criteria.

Nonconformities, Corrective & Preventive Actions

What is a Nonconformity (NC)?

A deviation from specified requirements or a failure to meet expectations. Often indicates a lack of effective requirements.

Types of Requirements:

  • Internal: Procedures, ways of working (e.g., someone not following a procedure).
  • Client: Specific client demands (e.g., incorrect product specifications like cream instead of chocolate filling).
  • Policy: Adherence to the organization’s quality policy.

Corrective Actions (AC) & Preventive Actions (AP)

Actions taken to eliminate the causes of nonconformities.

  • Real NC: Leads to Corrective Action (AC).
  • Potential NC: Leads to Preventive Action (AP).

Standard Requirements for AC/AP Process:

  1. Detect NC (or potential nonconformities) and report breaches.
  2. Implement Immediate Solutions (contain the nonconformity).
  3. Investigate Root Cause (to eliminate the source of the problem).
  4. Propose AC / AP.
  5. Monitor AC / AP Effectiveness (to ensure the implemented actions are effective).
  6. Closure of AC / AP (once effectiveness is confirmed).

Quality System Audits

A systematic review of the quality system.

Types of Audits

Internal Audits

Conducted by the organization itself; typically more in-depth and thorough.

External Audits

Client Audits

Conducted by a client on your organization.

  • Can be very thorough.
  • Can be outsourced.
  • Focuses only on the part of your system that affects the client.
Certification Audits

Conducted by a certification body (paid by your organization).

  • Can be stressful.
Audit Focus:
  • 1. Your procedures must align with the standard.
  • 2. Your actual practices must align with your documented procedures.

Audit Requirements

  1. An internal audit must be conducted at least annually.
  2. A detailed audit plan (e.g., daily schedule, areas like purchasing, production).
  3. Defined requirements for auditors (qualifications, independence).
  4. Audit Reports: The organization receives the audit results.