All Questions requiring follow up should have an Owner, Documented Action Plan and Projected Resolution Date.
1. Has an overall risk assessment been updated for the project? Are there significant risks that need to be communicated to upper management to facilitate better decision making?
2. Has the affordablecapital limit been established and where does the project fall with respect to that?
Are all capital, start-up expense, and on-going capital and expense costs identified with appropriate accuracy?
4. For SIMPL projects: Is the SIMPL status clear and linked to funding requests?
5. What are the risks that any cost area could be significantly outside the estimate range? How will this bemanaged? Are any of these risks significant enough to warrant communication to upper management and what is the plan to do that?
6. What is the funding strategy, contracting / construction strategy, and key milestones?
7. Have all organizations required for the project success adequately budgeted and staffed for the needed support?
8. How have Best Value Option Analysis and Life Cycle CostAnalysis been used on this project? Which options have been financially considered?
9. Have options been considered which would increase speed to market, increasing overall project return?
10. Is there a plan to do value stream mapping on the supply chain?
11. Do you understand the assumptions that are made in your project establishment assumptions?
12. Is there a plan to integrateShould Cost Analysis and Life Cycle Cost into the work process for the project?
Is there a spares reduction strategy in place?
Has an Attribute Process Matrix, Product FMECA, and Machine Quality Matrix been completed for this project? Are the product quality targets measurable and based on consumer requirements?
Has the transformation flowsheet been developed?
How have thequality targets for each criteria been allocated? How are the quality targets justified in terms of understanding of current operations and our understanding of the new operations/processes?
What is the plan to define the process capability robustness of new operations? Is there a plan to check process capability with material tolerance?
Has the product/package design been reviewed for hard tomanufacture issues? What options have been considered?
What potential risks might cause quality criteria outages and how are these being managed?
What is the plan/timing for finalizing packing material specifications/product specifications? Will the design be frozen prior to issuing equipment specifications and the design basis? If not what are the associated risks with this approach?
What arethe supplier qualification plans for new raw materials (including packaging)?
Are there known or expected major material variations? How will these be managed?
What are the plans to ensure the process / packing system will produce the desired quality?
Do analytical methods need to be created or updated? What is the validation protocol?
Is a microbial risk assessment required?
SAFETY/RISKAre the safety/risk targets for project execution and for on-going operation consistent with plant expectations?
What are the major risks as identified by the Overall Risk Assessment (ORA) and how will these be addressed? Have all health, safety, environmental, fire protection, medical aspects been considered?
Are there any new or existing hazardous, flammable or allergen materials involvedwith this project? What are the plans for managing these materials (permitting, storage, engineering controls, personal protective equipment, etc.)? Do these materials (including lubricants) meet the local legislation and P&G requirements?
What are the potential air, water, waste stream impacts? Are permits or permit modifications required?
Have critical work points been analyzed to reduce...