8.5.2: Identify the status of outputs

"The organization shall identify the status of outputs with respect to monitoring and measurement requirements throughout production and service provision."

Can anyone shed some light on this?

 

When test A, test B and test C are required to consider a part complete, you have to know whether test A has been done yet or not...whether test B has been done yet or not...and whether test C was done yet or not...and whether the outputs of the tests done meet requirements (specs).

If you define it necessary to monitor water content throughout your process at a certain level, you have to know whether water content was monitored throughout your process, and what the levels were.

Cold, weird wording...but simple, important requirement. If you require it to be done...is it being done?

 

When a product is ready to ship, how can you prove that it was finished being built, inspected and tested as applicable?

For our products, build documentation (travelers is a commonly used term) with serial numbers that match the S/N on the unit, and completion of the build, inspection and test portions with either persons signatures or stamps meet that requirement.

If your product line differs, you may need a different solution.

 

The definitions given in ISO 9000:2015 can help.

Monitoring - determining the status of a system, a process, a product, a service, or an activity.
Measurement - process to determine a value.​

Statuses related to monitoring can include:

• Cpk, dppm, stability of production;
• actual yield against the target;
• percent of project completion;
• condition of patient in a hospital;
• exact location of cargo in transit, etc.

Statuses related to measurement will include: Pass/Fail, Accept/Reject, Go/NoGo, Approved/Disapproved, Hold, For Further Verification, etc.