Reduce deviations per lot down to 0.8

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Reduce deviations per lot down to 0.8 af Mind Map: Reduce deviations per lot down to 0.8

1. Technicians need to speak up, be there own advocate to solve the problem.

1.1. They have been advised not to write in the batch records.

1.1.1. Tools/Environment/Knowledge

1.2. They don't know to speak up.

1.3. They are afraid to point anything out.

1.3.1. Motivation

1.4. They might be afraid of a negative performance review as a result.

1.4.1. Motivation

1.5. They are not rewarded for pointing out issues.

1.6. They may not be making the right people aware the issue.

1.6.1. Knowledge

1.7. They need a friend in QA that they trust.

1.7.1. Environment/Knowledge

2. Drafting accurate MPCRs

2.1. Time

2.2. We don't have the right SMEs reviewing them.

2.2.1. Capacity

2.3. They are not trained on how to review MPCRs

2.3.1. Knowledge/Skills

3. Technicians/associates need to be able to identify root cause

3.1. It is not an expectation for techs to do it.

3.1.1. Knowledge/Envrionment

3.2. They don't know how to do it.

3.2.1. Knowledge/Skill

3.3. They may not have the time to do it.

3.3.1. Envrionment

3.4. They may not have all of the information needed to identify.

3.4.1. Enviroment

3.5. Technicians/associates need to be able to identify contributing factors.

3.5.1. Knowledge/Skill

4. Provide better training for new or unique work we are asking them to do.

4.1. We don't have processes to do specific training on new work.

4.1.1. Envrionment/Knowledge

4.2. Time

4.2.1. Envrionment

4.3. Don't have the right capabilities.

4.3.1. Knowledge/Skill

4.4. Expertise of Tech Transfer and Business Dev groups

4.4.1. Knowledge/Skill

5. Be able to trend deviation data more accurately.

5.1. We don't have the right categories for trending. This is too broad and generic.

5.1.1. Environment/Tools

5.2. The description is not really what the deviation is. Don't have time to update the descriptions later.

5.2.1. Environment

5.3. We don't have the proper tool or system in place. How we setup the tool.

5.3.1. Environment/Tools

6. Be able to hold people accountable for identified tasks on the deviation from the project hopper.

6.1. Time

6.2. Visibility of the assigned tasks

6.2.1. Envrionment/Knowledge

6.3. Clarity on milestones and expectations.

6.3.1. Envrionment/Knowledge

7. Have better preventative measures on our equipment.

7.1. We need more money.

7.2. Some equipment does not have backups, because its old and we don't have money to replace it. May not be designed to do certain things for preventative measures.

7.2.1. Environment

7.3. We are still learning about new equipment

7.3.1. Knowledge/Envrionment

8. Take on things that are scientifically sound in our tech transfer process.

8.1. We do what the client wants

8.1.1. Envrionment

8.2. We take on multiple projects from different clients that are the same. But we can't communicate that to the client without breaking confidentiality.

8.2.1. Envrionment

9. Risk mitigation for a new process

9.1. As we bring in clients if they are skipping steps of the process. We need to identify risk .

9.2. we don't have clear expectations for how to identify risk for a new process

9.2.1. Knowledge/Standard/Envrironment

9.3. Human resources

9.3.1. envrionment

9.4. time

9.4.1. environment

10. Risk mitigation for deviations

10.1. We always do what the client wants

10.1.1. Envrionment

10.2. We do not push back enough on our clients

10.2.1. Envrionment

10.3. We have to proceed forward to gain revenue

10.3.1. Envrionment

11. Time

11.1. People are not cross trained. Single sourced.

11.1.1. Knowledge/Skills

11.2. We do what the client wants when they want it.

11.2.1. Envrionment

11.3. No clear standard of the amount of time required to do things.

11.3.1. Knowledge/Envrionment

11.4. Not adequately staffed.

11.4.1. Envrionment

12. QE's Do Root Cause Analysis

12.1. Rushed Deviations because of Batch Release

12.1.1. Envrionment

12.2. They go with the easy answer

12.2.1. Motivation/Time

12.3. QE's are not given all the information.

12.3.1. Knowledge/Skill/Environment

12.4. Working with the wrong people

12.4.1. Knowledge/Envrionment

12.5. QEs may not feel comfortable speaking up to their manager.

12.5.1. Environment