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
- Quality Policy
- Quality Objectives
- 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:
- Conducted at least once a year.
- 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
- Define requirements for purchased material or product (suppliers must meet these).
- 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:
- Detect NC (or potential nonconformities) and report breaches.
- Implement Immediate Solutions (contain the nonconformity).
- Investigate Root Cause (to eliminate the source of the problem).
- Propose AC / AP.
- Monitor AC / AP Effectiveness (to ensure the implemented actions are effective).
- 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
- An internal audit must be conducted at least annually.
- A detailed audit plan (e.g., daily schedule, areas like purchasing, production).
- Defined requirements for auditors (qualifications, independence).
- Audit Reports: The organization receives the audit results.