Role - Vendor.

Report addressing

1) Issues identified, 2) Priorities among issues identified, 3)Primarily underlying interest, 4) Interest of each person identified, 5) Resistance & BATNAs, 6) Target Points & opening request on issue, 7)Important constituencies to whom am accountable, 8) Identify Info about other negotiator, 9) Info to support negotiation is assembled (research, chart etc). Please address all 9 points.

Case Study

The Contract Manufacturer - Vendor Auditor Roles

Randy Regier and Darren Rau Auditors for ABC Chemicals

You, Randy Regier and Darren Rau, are auditors, and have worked at ABC Chemicals for about five years. You just audited an outside manufacturing facility that is scheduled to produce one of ABC's most-important new products, Delta C. The company's scientific research staff assessed the capabilities of the operations several weeks ago and found them to be acceptable. In fact, they recommended that the company use this facility. To quote their report, "This is an excellent, well-run facility."

The time line for this compound is extremely tight, but the facility has some unique systems that enable its staff to meet tight manufacturing requirements. However, when you audited the facility, you found some significant GMP deviations that you reviewed during the exit interview. The facility's management acknowledged the situation and assured you that your findings and recommendations would be addressed immediately. They did say that no one else had ever raised these issues and that they could not understand why they are of such concern.

You documented your exit interview, including all audit comments and recommendations agreed to by the plant manager, Angela Reid, and assistant plant manager, John Black. You requested an immediate response confirming the actions to be taken, even though you hadn't received the written response. You recommended approval of this facility because of Angela Reid's and John Balck's strong assurances during the exit interview.

Today, a week later, you received a letter from Angela Reid. You are very surprised to read that the confirmation" does not adequately address the findings or the agreed-to actions. In fact, the entire letter as vague and general. You are furious; the actions were very clearly stated and agreed to in the exit interview. You can't start looking for a new facility now; production of Delta C is scheduled to begin next month! You need to meet with Angela and John to come up with an acceptable resolution to this problem right away. GMP standards must be met, and the production of Delta C simply cannot be delayed. In your mind, the GMP issues could be resolved if Angela and John start to address them immediately. However, you realize that this might affect some of their other commitments. If Angela and John had started to address the deviations when they said they would, the problems would be well on their way to being resolved.

You called Angela and John to set up an appointment, and indicated your annoyance. You spoke with your management and everyone was very clear: "We have no real options. This needs to get resolved so that production can begin and we can stay on schedule." Everyone agreed that you have the authority to work out the problem.

You will meet with Angela Reid and John Black at the facility in the next few minutes. You will need to negotiate an agreement to addressing the deviations in order to approve the facility and start manufacturing Delta C in one month.

Known to Both Parties

Here are the items that Randy and Darren referred to during the exit interview and in their letter:

• Temperature and humidity are not monitored in the compounding area. Delta C is very sensitive to minor fluctuations in humidity.
• There is no system for tracking equipment-calibration due dates. Randy and Darren noted that several pieces of equipment are past due calibration.
• There is no master plan for equipment-cleaning validation. Most cleaning processes have not been validated. The chemicals are water-soluble, so that is not an issue of concern.
• There are no procedures for investigating failures.
• A new segment was added to the USP water system, but there has been no formal validation of the entire system after this change was made. There have been serious occasions of off-limit microbial counts in the USP water that have gone uninvestigated.
• Production of Delta C is scheduled to begin one month from the date of this meeting.