Show:
7.1 + 7.2
7.3, 7.4, and 7.5
8.2 + 8.3
8.4 + 8.5
8.3, 8.6, and 8.7
100
The organization had assembled a database of Lessons Learned for their production process, but the database was only accessible to the IT staff.
What is Nonconforming? 7.1.6
100
Personnel were not able to say what would go wrong if they failed to follow their procedures.
What is Nonconforming? 7.3d
100
The organization's order review process requires that documented information be maintained to show results of the review and any new or changed order requirements.
What is Conforming? 8.2.3
100
A new piece of product equipment was installed. The effect of the change was reviewed and approved by the head of the process engineering.
What is Conforming? 8.5.6
100
The organization retains documented information resulting from design and development outputs.
What is Conforming? 8.3.5
200
A machine used for determining chemical composition was calibrated once a year, but there was no maintenance routinely performed on it.
What is Nonconformity. 7.1.5b
200
The organization approved all its documented information, but responsibility for review had not been assigned.
What is Nonconforming? 7.5.2c
200
To get ready for an upcoming audit, Chris updated the company's documented information to show results of the review and any new or changed order requirements.
What is Conforming? 8.3.3e
200
The quality manager at ABC company provides management with supplier reports. These reports provide a quarterly summary of the supplier selection checklist, trend data on supplier quality and on-time delivery results, and any re-evaluation decisions made.
What is Conforming? 8.4.1
200
Andon Company is a high volume manufacturer of baby clothes. In order to meet poorly scheduled customer orders, the company has to make shipments without completing the required inspection. This happens about 30% of the time.
What is Nonconforming? 8.6
300
Necessary competence for top management had not been determined, because they were the sole owners of the company.
What is Nonconforming? 7.2a
300
All documented information was maintained on company computer servers, but there was no established process for periodic backup.
What is Nonconforming? 7.5.3.1b
300
J-horse company, in order to save costs, outsources its order taking process to an off shore company. Once an order is received, it is immediately scheduled for production. No one checks to see if order requirements can be met.
What is Nonconforming? 8.2.2b
300
When purchasing raw materials, the company includes personnel qualifications on the purchase order form.
What is Conforming? 8.4.3c
300
The design engineer did not think it was important to have the customer be part of the design process. The design plan did not include customer review.
What is Nonconforming? 8.3.2f
400
The organization had not implemented a preventive maintenance program.
What is Conforming? 7.1.3
400
The company maintained separate procedures for Control of Records and Control of Documents. They did not use the term "documented information."
What is Conforming? 7.5.1
400
The organization's customer communication policy requires account representatives be the point of contact for all customer communication including, but not limited to, enquiries, order issues & complaints. Account reps could not answer or address specific customer questions on expected delivery dates after recent power outages.
What is More Information Needed? 8.2.1e
400
Labeling and packaging provided by the customer is given a specific identifier and tracked throughout the production process. Pallets are provided by suppliers and are owned by the suppliers. They are not identified as being supplier property.
What is Nonconforming? 8.5.3
400
ABC Company allows its engineers to give verbal concessions, as appropriate on nonconforming products shipped that do not meet customer requirements.
What is Nonconforming or More Information Needed? 8.7
500
Temperature and Humidity were not measured consistently in the testing lab.
What is More Information Needed? 7.1.4
500
The organization decided to conduct all of its internal and external communication via internet website.
What is More Information Needed? 7.4
500
The customer has never provided engineering drawings or specifications for the product. The organization has excluded design & development from their QMS.
What is Nonconforming or More Information Needed? 8.3.1
500
All incoming product receive a visual inspection on "10% of the lot". Some of the products have a higher scrap rate than others.
What is Nonconforming? 8.4.2a
500
To control the design process, the organization conducts three design reviews during a design life cycle, and then approves the design.
What is Nonconforming? 8.3.4