38. Quality Audits
Quality 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
Before initiating quality audit, the following preparation shall be considered and implemented.
Review quality audit scope and detail audit items within the audit team members before assigning scopes.
Ensure availability of supplier’s top management before establishing the audit availability. Since Quality Representatives and Management Representatives shall be present during the quality audit.
Tools such as audit checklist, audit score criteria, supplier process knowledges, supplier’s quality goal and management can also be integrated for the audit preparation.
Issues or improvement points cumulated from previous audits
Notify supplier regarding the audit time, scope, information which supplier required to prepare.
This is generally supplier’s self audit check sheet before having the official audits. Can use this as a reference before having the actual audit.
During the on site audit, the following scopes can be broken down for the audit criteria
Quality Audit Scopes
And specific scope’s information is referred below
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.
During the audit, there’s generally the 4M1E approach to gather necessary information to ensure the supplier’s compliance with respect to audit items. The full explanation for 4M1E is listed below.
4M1E Scope
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.
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.
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
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Very useful information to understand the roadmaps for quality audit and related action.