Manufacturing Process Audit

Manufacturing Process Audit | Objective

Manufacturing Process Audit focuses on product quality and the associated processes to determine the quality capability of selected products and product groups and their processes.

The objective of the manufacturing process audit is to determine the production capability to deliver products and services to satisfy the customer requirements in terms of safety, quality, and quantity.

Manufacturing Process Audit Preparation

• Establish the purpose of the audit clearly i.e. preventive measure or to solve a specific quality problem.
• All relevant standards/documents should be collected.
• Investigate the previous quality performance of the part and collect the relevant data (rejection ppm, problem from the market or the customer, line problems previously reported).
• Collect the previous audit & corrective actions report.
• Prepare a checklist of the critical areas that have to be checked to ensure that all the critical areas are covered.

Responsibility:
The overall responsibility for auditing shall lie, in principle, with Quality departments

Manufacturing Audit Checklist | Manufacturing Audit CheckSheet

The Manufacturing Process Audit check Sheet may include the following areas:

• Documented work instructions/process control parameters
• Check for job/machine setup before regular production
• Machine jigs/fixture control
• Die/mould/tool control
• Process Control
• Incoming/In process/Final Inspection
• Storage/Handling
• Traceability & FIFO
• Identification
• Calibration of inspection/measuring instruments
• Corrective & preventive actions
• Control & monitoring of special processes
• Plant layout for smooth material flow & 5S
• Statistical Process control
• Process Effectiveness
• Inventory Control
• 4 M change control
• Poka Yoke Working (Prevent error/Defect generation)
• Part Mix-Up Prevention
• Rejection/Rework/Breakdown Control
• Defining of Time frame for closing corrective actions of Process audit findings
• Effectiveness of Actions taken/quality checks.

Annual Audit Plan

An annual audit plan should be prepared for manufacturing process audits at the beginning of every year.

Performing the Audit

Following are the guidelines for conducting the audit as per plan:

• Follow the checklist.
• Conduct the audit step by step.
• Go into details and see yourself.
• Don’t assume things & look for objective evidence for both compliance & non-compliance.

Audit Records

Audit results and improvement action plans must be recorded systematically and regular follow-ups must be done to see that problems pointed out during audit are improved upon or closed. Records of in-house audits should be made a part of top management review.

Corrective Actions

Against the audit result findings or Opportunities for Improvement, “Corrective Actions” should be prepared and followed up with the concerned department in its company, till the corrective actions or countermeasure is/are permanently implemented.