Testing & Inspection Explained [ISO 9001 Procedure]

Application And Scope Of The Procedure

The company will undergo inspection and testing and will have implemented all the correct methods to measure and monitor the product characteristics. This will also verify and confirm that all requirements are met.

The procedures apply to all incoming materials, articles in process, and final products. No items—including materials or components and final products—can be packaged or dispatched until all relevant inspections have been completed.

Who Is Responsible For The Testing And Inspection

The person primarily responsible for maintaining the QMS, internal inspections, and testing would be the Quality Manager or Quality Assurance Manager. The scope of their responsibilities are:

• To determine the scope and extent of all in-process testing and inspections
• To determine the full spectrum of product testing and inspections
• To ensure all planned arrangements are completed in a satisfactory manner and before product release
• To make sure the exact procedures are followed and implemented throughout

Responsibilities Of The Quality Inspector

The quality inspector can either be an internal person of the head office or an external person sent from an auditing firm. The QI has specific responsibilities, namely:

• To undertake the testing and inspection in a non-bias manner, ensuring all specified requirements are met
• To preserve the identification of inspected products
• To safeguard the identification of testing products

How Is The Inspection & Testing Process Executed?

Before any materials, products or components are cleared for use, packaging, or dispatch, all required inspections must be completed. A new assessment must be done to determine if any product has been modified or altered. All records need to be preserved.

4 Types Of Inspections For ISO 9001

1. The Receiving Inspection

The primary inspection will be executed in the receiving section; usually, it will proceed as follows;

• Upon receipt, the receiving bay personnel will verify the units delivered and make sure the packages are identified
• Check all boxes or packages for any signs of damage or tampering
• The staff notes any damage or shortages on the delivery note
• After the inspection, the staff in charge signs the delivery note
• After this is done, a copy of the purchase order is verified against the items in the packages
• All the items are inspected for signs of damage or tampering
• The purchase order gets stamped with the “RECEIVED” stamp and signed by the receiving manager
• The inspection is logged in the Receiving Inspection Log

2. The Critical Parts Inspection

Usually, the Quality Manager will determine which parts and components will be subjected to precision inspections. They mainly consist of:

• A review of the parts certificates, the inspection record from the manufacturer or supplier, and the certificate of compliance
• A close visual inspection should be done to detect any defects or damage.
• Random sampling is done on the specified technique
• Perform the specified tests against the requirements
• Record the inspection test, the sample size, and any measurements using the Inspection and Test Report Sheet
• Record any defective or damaged items on the Defective Part Report
• All materials, parts, and products used in the production line or manufacturing process must be inspected and tested by the QM personnel

3. The First Article Inspection

The QM personnel does the first article inspection, specifically the quality inspection personnel. They should examine every first article by reference to all machining samples, programs, other data, or any prints of any part used to produce more than three identical parts;

• Examine – critical dimensions like inner and outer diameters, threads, tapering surface finishes, width, depth, and height
• Perform a fit and function test of the machining process using the test parts specified on the drawings
• Perform the first article inspection on each part consecutively until the most extensive part has been built up to the target range for all the dimensions
• Initial the Test Sheet or Inspection Report at each new inspection or test performed, indicating the acceptance of that part and a successful test and inspection
• Capture all first article inspections in the First Article Inspection Logbook, and this provides traceability to the inspector
• All defective parts need to be logged in the Defective Part Report. Process them accordingly

>> Learn more about First Article Inspection

4. The In-process And Final Inspection

In-process inspections are usually carried out during the manufacturing processes. The QM personnel perform the assessments, sometimes including walkarounds, peer reviews, and random process audits. These inspections ensure the process conforms to the set specifications and requirements.

Usually, the Quality Manager determines the scope of the inspection and testing. This will be thoroughly communicated to all personnel. This procedure usually includes;

• Holding back products until all inspections have been finalized
• The work order is reviewed to ensure all first-part inspections, processes, and specified operations have been completed—the relevant supervisor signs off the sheet
• Check that all documents are traceable to each product and made available for inspection
• Perform a visual inspection to verify that all specified operations have been completed. This is also done to detect any visible damage or defects
• Goods are released for packaging and shipping after the final inspection has been completed