QMS Auditing
Introduction
Quality Management System (QMS) audits has always been one of the common manufacturing practices whether it’s getting audited by customers, internally audited or auditing suppliers. In this section, details of quality audits and preparation information will be illustrated based on the cumulative experiences from being audited by OEMs or auditing upstream suppliers.
In general, quality audits will be primary focusing on the following (but not limited) scopes listed below
- Quality Management System Implementation and Execution
- Raw Material Supplier Management & Evaluation
- Design Implementation & Realization
- Raw Material Purchasing Process Flow
- Quality Control (IQC, IPQC and FQC)
- Nonconformity Handling
- Material Storage Management
- Risk Analysis and Implementation
- Production Process Implementation
During the on site audit, the following scopes can be broken down for the audit criteria. In addition, the auditors can refer to the 4M1E approach (Man, Machine, Material, Method and Environment) to audit.
Scopes include quality management system’s risk evaluation implementation, roles & responsibilities, quality goals and policies along with training plan/qualifications.
But different industries will refer to different QMS application. For instance, automobiles will have IATF 16949 in addition to ISO 9001, medical device would refer to ISO 13485…etc.
Information can include designed specification, design transfer record, billing of material, customer notification for change, product realization timeline (start from New Product Introduction phase all the way to mass production) .
Verification test plans for product trials and respective results. Reports such as functional test report, dimension report, process capabilities can be considered.
On site production management including 5S, process flowchart, production equipment maintenance record, production control plan, first article inspection, changeover record…etc.
What suppliers do when nonconformity occurred for production, quality system, customer complaints and inspection. This also review the mechanisms of supplier’s corrective and preventive actions. Also need to verify the effectiveness of the nonconformity handling cycle.
Auditing Techniques
The following process flow summarizes the general scope for QMS audit from very beginning until audit completion.
Before auditing, QMS professionals can refer to the following process flow diagram to formulate the necessary questions for respective QMS processes.
In addition to the questionaires, the following diagram will summarize how audit plan was circulated within the PDCA cycle.
When performing on-site audit, the following trail is how audit information and observation are formulated before concluding the audit.
Throughout the audit process, auditors shall keep mutual and fair stance to observe the facts and evidences from the audit findings. And also remember to know that audit is an opportunity to find improvement within the system, so how to communicate with suppliers fairly while respecting supplier’s profession is a mutual balance for auditors as well.
Additional recording for information such as production record’s integrity and correctness (Good Documentation Practice), review and questioning from operators, production data and process parameter, error proofing function and risk based approach will be the correct methodology to gather necessary information for validating the compliance for audit items.
Based on the following summaries, the following bullet points will summarize the suggested points to ensure the audit is successful and able to help suppliers identify their opportunities to improve.
- Have ability to ask the right question
- Have the ability to listen
- Have strong sense of observation
- Have proper recording throughout the audit
- Able to create a mutual and friendly communication
- Effectively use quality audit checksheet and evaluation standard
In conclusion of the audit, audit reports shall be presented and summarized the audit findings along with improvement requirement. The following bullet points will be the key points to summarize the audit and requesting improvement from suppliers.
- Synchronize audit findings as a total summary
- Indicate supplier's strength and weakness from the audit findings.
- List necessary observations for required improvement and suggestions
- Summarize the action timeline for the improvement plan
- Provide the requirements if re-audit is required
- Appreciation for supplier's personnel for participation
Required ISO 9001 Documentation Clauses
The following are the list of clauses for ISO 9001 which required DOCUMENTED records.
- QMS Scope (4.3)
- Process Operation Documentation (4.4)
- Quality Policy (5.2.2)
- Quality Objectives (6.2.1)
- "Purpose Matching" Resource Measuring/Monitoring (7.1.5)
- Calibration/Verification Principle (7.5)
- Competency Evidence (7.2)
- Evidence showing that process is executed as per plan (8.1)
- Customer Request's Evaluation Result (8.2.3)
- Confirmation of Design's Development Requirement, Input, Control, Output and Related Changes. (8.3.2; 8.3.6)
- External Provider's Evaluation, Performance Monitoring and Re-evaluation, and countermeasures after evaluation (8.4.1)
- Product and Service's Characteristics (8.5.1a)
- Executed Activities and Achieved Results (8.5.1b)
- Required Product Traceability (8.5.2)
- Product/Service's Change Evaluation (8.5.6)
- Product/Service Release Authorization for Customer (8.6)
- Nonconformance Output, Product and Service's Countermeasure (8.7)
- Monitoring/Measuring Result's Evidence (9.1)
- Internal Audit Plan & Audit Results (9.2)
- Management Review Results (9.3)
- Nonconformance and Corrective Action Deployment (10.2)