Author: Judy Malsbury
Last saved by: FMalinowski
Company: PPPL

The MIT/QA Plan Issue
W. Reiersen
Terminology 1
•	Product specification: A document generated by the customer identifying requirements (performance characteristics, applicable standards and statutory regulations, packaging, etc.) and the inspections and tests that are required to verify that those requirements have been met (acceptance criteria).
•	SOW: A document generated by the customer that specifies requirements to be imposed on a supplier that are not typically found in a product specification. Examples are requirements for services and requirements for a supplier quality program. The latter might define  QA program requirements and supplier deliverables, including a quality assurance plan, procedures for acceptance testing. Guidance on qa requirements may be found in QA-003.
•	MIT Plan: A document generated by the supplier defining the process by which an item is manufactured what inspections and tests will be performed and when these inspections and tests will be performed.
•	IT Plan: A document generated by the supplier defining what and when inspections and tests will be performed. It is a subset of the MIT plan, used when the manufacturing steps are of no concern to the customer.
Terminology 2
•	QA Plan: A document generated by the supplier describing the specific QA/QC procedures and practices for the procurement.
•	MIT/QA Plan: A document generated by the supplier that contains the information required by both the MIT and QA Plan. For example, the MIT/QA plan might identify or include the procedures associated with specific identified activities, usually special processes; these procedureswould, in turn, describe the actions taken to assure the quality of the activity.

The Issue
•	The issue is with the QA part of the MIT/QA Pla [Comment by Judy Malsbury (JAM), 2004-08-13: I totally disagree with this. The issue is planning - taking the time to generate a real and useful MIT Plan and assuring that the appropriate quality processes are in place to support the MIT. I truly believe that taking this time, in the long run, saves time and angst.]n [Comment by FMalinowski (FM), 2004-08-13: I would not identify this as "the issue". It is the key issue withthe two prototype MCF suppliers because they addressed the MIT requirement by sending the sop traveler or router thaey would generte anyway and ignored the QA Plan because there was not a corresponding document normally used in their work that they could hand us.]
•	Documenting the manufacturing process and identifying when inspections and tests will be performed is simple and can be done in a flowchart.  It can also be a useful planning tool for the supplier [Comment by FMalinowski (FM), 2004-08-13: This flow chart could easily include pointers to procedures and then it is an MIT/QA Plan. We don't typically look for all the procedures that will be followed - the focus is typically on the special process procedures. (and I realize that I sometimes went further on the prototypes, but we were dealing with a couple of companies that did not have QA Programs and a company that said their QA Dept was not involved even though their QA Program said they were.)].
•	Documenting [Comment by Judy Malsbury (JAM), 2004-08-13: Requires thought, but again saves time in the long run.]how all of the procedures and practices that will be followed actually meet the QA program requirements can be onerous
Suppliers must have an adequate QA program

DOE O 414.1A on Work Processes [Comment by Judy Malsbury (JAM), 2004-08-13: While this is the criterion that is most directly applicable to these contracts, all of the criteria are applicable. For instance, the people doing the work must be trained and qualified (criterion 2).]

1	Work must be performed to established technical standards and administrative controls using approved instructions, procedures, or other appropriate means.
2	Items must be identified and controlled to ensure their proper use.
3	Items must be maintained to prevent their damage, loss, or deterioration.
•	Equipment used for process monitoring or data collection must be calibrated and maintained.

A path forward 1
•	Require an MIT Plan when sequence of operations, including inspection and/or tests, is important, or when witness and/or hold points need to be identified.
•	Require an IT Plan when sequence of operations othr than inspections and tests is irrelevant. 
•	Require only the inspection and test results if all inspections and tests are standard and can be performed on the finished article
A path forward 2
•	Require documentation of procedures for manufacture, inspection, and test when the risks associated with the procurement are adequately high. Possible risks include potential significant impact on costs or schedule, when the procedures are critical, difficult, and/or non-standard, when the supplier has limited experience and expertise in an operation. Procedures requiring review are typically those for special processes – those processes, such as welding, heat treatment, or nondestructive testing, that would be impractical to verify on the finished item. •	Avoid requiring a QA Plan when [Comment by FMalinowski (FM), 2004-08-13: I gotta ask that Judy's comment here be taken appropriately. This is not, Hey, go audit them next week. It takes preparation and research, schedule shifting, and time at the supplier's facility. I would typically try to get audits by others, a QA Manual, a list of procedures, maybe a couple of specific procedures and go through all of that and customize a standard checklist and then spend 2 days in the plant. I would want a minimum of 1 to 1 1/2 weeks to prepare, 2 days in-plant and 1 1/2 days to prepare the report. I talked to ORNL QA and this is less time than they typically ask for to get a qualification audit done. If we used a pre-audit questionaire (a good practice) like ORNL, we would also need time to get it out to them, have them complete it, and then digest it here.] not needed [Comment by Judy Malsbury (JAM), 2004-08-13: Recognize that qualification a supplier's QA program is a good idea but does take time to do. You cannot audit a supplier in a few hours - a few days might be more reasonable. Time must be built into the schedule to do this. Also, PQA needs the resources to do this.]
–	Pre-qualify the supplier’s QA program prior to contract award
–	Conduct audits to verify that the procedures and practices being followed meet the requirements of the QA program
•	Modify the guidelines for preparing SOWs to reflect these considerations [Comment by FMalinowski (FM), 2004-08-13: The QA guidance in ENG-006 is very sketchy now. I forgot that they dropped the whole pointer to QA for guidance. My suggestion would be a line pointing folks to the QA web page, where this stuff should be added, for guidance.].
•	Provide training opportunities on writing specs and SOWs [Comment by Judy Malsbury (JAM), 2004-08-13: I agree with Rich that Procurement Technical Reps need training, not only on how to write specs and SOWs, but also on their responsibilities - what they are allowed to do and not allowed to do. I personally have had experience with PTRs ignoring important requirements within their specs and SOWs, sometimes before a contract is awarded, sometimes afterwards. For instance, we request a specific document for review as part of the RFQ but issue a contract without ever receiving it. I also am uncomfortable about what occurs during the informal dialogs between the PTRs and the suppliers. It would also be helpful if the PTRs had a better understanding of the QA clauses. In my experience, I have seen PTRs view QA's role in developing a specification or SOW as a required step with limited impact on their work or responsibilities.].