Performance verification for critical equipment

[Former Member]

Hi,

in Pharma industry all critical equipment have "performance verification" as per defined frequency (i.e. Quarterly, half yearly, yearly).

now i have to map this scenario.

i m confused that in which module we will mapp this scenario? (QM or PM)

Just like in stability, for every time point auto lot generated from "16- inspection type" same way for the "Performance verification" some inspection lot will be generated as per defined frequency.

one Equipment have more than one frequency also.

Also i have to monitor that at which date the "Performance Qualification" will be due? (AS QA point of view)

Can anybody guide me to mapp this scenario?

Thanks & Regards.

Ms.Kruti Shah

[Former Member · Accepted solution]

Hi Kruti,

You have to use "Test Equipment Calibration" component of SAP QM for this. This has an integration with PM module. In genereal, steps are:

1. Have a discussion with PM regarding equipment master, cycle plan, etc.----- He will give you a fair idea about maintenance

2. Create equipment in IE01--- Here you maintain all data related valid from, category, equipment location, planning plant, manufacturer, etc

3. Create general task list in QA05---- Corresponds to the inspction plan for QM. Put usage, status, inspection point, operation, MICs, etc

4. Make maintenance plan in IP01--- Here few main fields are cycle, task lists, main WC, order type, etc.

5. make maintenance order in IP30-- Deadline monitoring for plan. As per cycle, plan will be scheduled.

6. release order in IW32--- for releasing the order. Put settlement reciever, start-end date, reported by, priority, etc.

7. In QA32, lot will be generated. Do RR and UD.

If you are using sampling procedure, ypu must select plant maintenance in inspectopn point.

I have given you a very generalized idea of calibration. you can customize this as per your requirement.

Edited by: Swarnali_D on Jul 9, 2010 5:23 PM

[Former Member · Accepted solution]

Hi Moti,

Just one more point to add ..In SPRO --->PM --->Maintenance and Service Processing -

---

>Maintenance and Service Orders -

---

>Functions and Settings for Order types --->Assign Inspection type to Maintenance orders , here for your combination of plant and order type PM05 calibration order assign 14 inspection type for generation of inspection lot while releasing the calibration order .

plz find the IDES Version of calibration processing (http://help.sap.com/saphelp_46c/helpdata/en/fe/67ec5c9d6f11d189b60000e829fbbd/frameset.htm) refer MP for calibration measurement instruments.

regrds

pushpa

[Former Member · Accepted solution]

Hi,

Thanks for your suggestion but my Qauestion is lillte bit different.

1) We have Equipment master in PM module.

2) Calibration scenario already mapped in PM with maintainance oreder with "14" inpsection type.

3) This is related to performance verification which is different from Calibration scenario.

4) i dont understand that what we have to do in QA05?

5) I want another inspection lot for "Performance verification" except "14".

6) We have defined frequency with test paramater. e.g. HPLC have PV frequency 3 month, 6 month & 12 month with different test parameter.

7) now i want that at each time point, i required auto generation of inpsetcion lot with defiened inspection plan in QA32. After testing will be completed, we will give UD and declare as this Equipment is Qaulified.

It is different from Calibration scenario.

Calibration actvity done by PM member but perfomance activity monitor by QA (QM) person.

Pls help me to design this scenario.

Thanks & Regards,

Ms. Kruti Shah

[Former Member · Accepted solution]

Hi

I couldnt understand your point.

3) This is related to performance verification which is different from Calibration scenario. --- What do you want to verify?

4) i dont understand that what we have to do in QA05? In general task list, inspection characteristics are maintained ( Like weight, diameter, frequency, etc). Its like an inspection plan.

5) I want another inspection lot for "Performance verification" except "14". --- Didin't understan. How sytem would create a lot in QA32 if you dont activate coresponding inspection type?

Calibration actvity done by PM member but perfomance activity monitor by QA (QM) person. --- Test equipment calibaration is an integration between QM and PM, where performnace/ quality of equipment is checked in the form of doing RR and taking UD. PM part is ti generate the maintenance plan and order.

Kindly write what are you going to veryfy as performance. If you want a inspection plan, you must be having MICc.

[Former Member · Accepted solution]

Hi,

1) Calibration activity is for instrument which is done by Eng. Dept or out side party BUT performance verification done by Diffferent user dept. for critical Equipment.

2) In PV, User have predefined MIC as well as Plan.

3) in calibration scenario, inspection lot has been generated through "14" so i want another inspection type which will identify that this inspection lot will be for PV not for Calibration by User.

4) I dont require any maintainance order becz it has been designed with calibration.

5) i want that at defined frequency, inspection lot will be generated for particular equipment, User will record the result and UD will be made by QA person. In this scenario, PM person is not involve directly.

6) As well as i dont know how to mapp with the help of QA05. i think it is for scheduling.

i think now it is clear.

If u have any doubt to understnad the scenario, pls let me know.

Thanks & Regards,

Ms. Kruti Shah

[former_member494495 · Accepted solution]

Hi

You don't want order of 14 inspection type because it was used by PM guys.

You can generate Notifications through Maintenance plan IP42 with Notification type related to your department (for example S1 / QM1) or customize the notification type for your requirement.

For more than one frequency like one critical equipment to be inspected in quarterly, half yearly and annual -

use maintenance strategy.

Regards,

Alagesan M