Process Validation and Capability

Hello,

I need you to help me with your comments and experience in one case. I have bakery product which are required to process validation and capability.

Does anyone know what type of process validation and capability types below mention?

1. SPC Program: SPC program has been implemented for process control and statistical analysis to improve consistency of product quality.
2. Process Control: Critical to Quality Manufacturing Control Points (CTQMCP) in each process have been identified for which control is necessary in order to create consistent finished product. The operator for each production line has been provided with measurement devices to determine the effectiveness of the process adjustments made (e.g. quantifiable cause and effect).
3. Visible Process: Real time control charts are used at all identified locations on processing lines for the critical to quality manufacturing control points. The operator only makes necessary adjustments when process is out of control as indicated by the chart.
4. Stable Process: When special causes/incidents (out of control points) are indicated in the control chart, the CTQMCP operator identifies and documents the root-cause, corrective action is taken and also documented.
5. Capable Process: Processes are capable to meet product specifications or manufacturing targets, demonstrated by the following characteristics:

- Control chart (with upper and lower limits)

- Real time control charting is being used

- There are no unexplained out-of-control conditions

- The data fits a normal curve

1. Optimized Process: A process is in place to update the process sigmas and optimize the targets with the real time control charts. Statistical data is used to manage process improvement and optimize processes. Increased product quality and consistency, reduction of waste, and cost savings are evident as a result of process control implementation.

Thank you.

PS: if you have information is specimen work sheet for procedure or work out of products that, i would greatly appreciate it.

Regards,

Ashfaq Hussain

Hi, AShfaq.

Apology, I did not understand the question. We employ the above and uses FMEA (and other tools) to help us improve our quality monitoring. AS for the control chart, we have deployed several rules that will enable the system to react depending on the data that is charted.

e.g.

If there are 3 data points on warning limit but still within specification, the system will react.

If there are 5 data points that are all in increasing/decreasing trend, the system will react.

etc..