“Consultant Forum” (CF) provides a vehicle for pharmaceutical industry managers and consultants to share information about their interactions in the daily work environment. Perspectives from both sides of these relationships will be addressed. The information provided in these discussions should be helpful and practical so as to enable application in actual work situations. Our objective: Useful information for both the client and the consultant.
Suggestions for future discussion topics are invited. Readers are also invited to contribute manuscripts for this column – please share your successful practices with others.
The role of consultants in the pharmaceutical, biopharmaceutical, vaccines and medical device industries is significant. Consultants provide experienced resources in crisis situations when new facilities are being installed, under circumstances requiring a high input of technical expertise, during regulatory emergencies, remediation’s, consent decrees, and other planned and unplanned situations. Problems often occur between clients and consultants. Both clients and consultants contribute to these problems. Inadequate short and long-term objectives between consultant and client is a relevant activity that is often poorly conducted. Establishing short and long-term objectives between client and consultants creates a key opportunity to begin a successful client-consultant relationship.
Mini-cases shall be presented during the phases of this paper to indicate the pros and cons of not establishing short and long-term objectives.
Due to the fact that the application of national and international business platforms are trending towards the increase of utilizing consultants to complete small to large capital projects, the client needs to define short and long-term objectives in alignment with the project’s Management User Requirements (MUR). If the client does not successfully define short and long-term objectives, the project will fail leading companies to potentially receive unnecessarily large amounts of FDA (Food and Drug Administration) 483 (s), warning letters, or consent decrees which consequently may result in the manufacturing facility to be permanently closed or seized.
Setting short-term and long-term objectives is an important activity that is often poorly executed. Consultants estimate that as much as 75% of projects suffer from lack of short and long-term objectives provided by the client to the consultant. A thorough and comprehensive discussion about setting up realistic objectives should be followed by prioritizing the goals using a risk-based approach. Then, identifying tactics or methods, establishing a measurement system/approach, and producing weekly follow-up reports will increase the probability that both the consultant and the client are meeting the management user requirements and/or service requirements.
NOTE: Discussion about supplier management (Service Level Agreement or Master Service Agreement) is outside the scope of this paper.
The following paper summarizes the input received from multiple consultants and mini-cases will be presented. The topics to be outlined are indicated below:
- Establishing objectives
- a. Developmental Plan (Optional used for large capital projects)
- b. Management User Requirements (Optional used for large capital projects)
- c. Establishing short-term objectives
- d. Establishing long-term objectives
2. Prioritizing the goals using a science risk based approach
- a. Can use a FDMEA approach in Excel format
- b. Can use a matrix approach or tabular approach
- c. Can use ASTM-E2500-13 or ICH-Q9 approach
3. Identifying the tactics or methods needed to effectively attain the goal.
- a. Developing a Checklist
- b. Posting goals above your desks or printing the goals and attaching the print outs in a close visual proximity preferably on your computer/desk
- c. Providing hard or electronic copies to all team members involved that support the attainment of the goals
- d. Writing notes on the fly in your numbered hard covered book as you are meeting with individual stakeholders (those involved in the attainment of the goal) or during your kick-off meeting/other meetings
4. Establishing a measuring system/approach: Monitoring the progress on how the goals are performed during the execution phase
- a. You can use a matrix table against the Management User Requirements or develop matrices against the Management User Requirements
5. Producing weekly status or follow-up reports against the objectives
- a. Weekly report
- b. Weekly meeting
- c. Weekly wrap-ups including follow-up and projected tasks for the subsequent week
- d. Performance Evaluation
Developmental Project Plan:
The client and the consultant should work together on establishing a developmental project plan during the first week of work based on company’s template after the client provided an overview of the project. The project plan should be updated by the consultant based on additional input information received by the client or stakeholders involved in the project. The project plan entails the following:
- Management User Requirements (MUR):
The management user requirements will be identified by a traceability numbering system that can be done by tabular method or matrix table so that you can identify the list of tasks mandated or requested by the client. The identified number will then be referenced to a corresponding test or verification method that is intended to be performed to meet the client’s MUR. As additional information is provided during the course of the project, the MUR document will be updated to the next revision number by modifying, deleting, or adding additional numerical MUR’s as part of its life-cycle paradigm.
The Developmental Project Plan and the Management User Requirements are recommended to be done for large capital or complex projects only. For smaller projects, the short-term and long-term objectives should minimally suffice in lieu of a separate Developmental Project Plan/document and MUR document.
- Establishing short-term objectives:
As a prerequisite of obtaining long-term objectives, the client should first define a short-term objective criteria list with the expectation of providing a targeted realistic completion of all deliverables, starting with the first deliverable to the “Nth” deliverables. The short-term objectives may be reevaluated as project changes occur while factoring in back-up or short-term contingency objectives as a substitution plan in case hurdles or show-stoppers are presented. Moreover, the client can still provide a very brief sentence or two on how the short-term objectives are correlated with the attainment of the long-term objectives without going into too much depth.
The following sequence are recommended to ensure that the objectives are satisfactorily met:
- Short-term objectives must be in alignment with the company’s services, management user requirements, and processes.
The client is highly recommended to briefly explain how the short-term objectives are a subset to the long-term company’s services, management user requirements and processes.
For example, one consultant was told to write an IQ, OQ, and PQ pertaining to validating the “Tanks.” Despite this, the consultant used the company’s boiler plate templates to generate the protocols and there were no instructions in the protocol to specify that before and after testing, the tanks should have been cleaned per the requirements specified in SOP “ABC.” The purpose of the “cleaning requirement” is to ensure that there are no contaminates introduced in the tanks or ancillary equipment that can potentially affect the PQ results. As a consequent, a non-conformance report had to be written within the executed PQ protocol and the PQ needed to be re-executed due to undesirable contaminates in the tank causing a failing PQ result.
NOTE: All template generated need enhancements or additional input information to be transcribed since perfect templates do not exist as they are continuously undergoing changes based on the life-cycle approach of the project.
- Establishing long-term objectives
Once the short-term objectives are successfully completed to the client’s satisfaction, then we can begin to discuss how the consultant can meet long-term objectives. The elements of the long-term objectives are indicated below:
- Transferring added value input information from Local Site (Short Term) to Global Site (Long-Term) within the company.
For example, Company A (A Corporate European Based Multi-National Pharmaceutical/Medical Devices Company) bought Company B (An American local start-up Medical Device Class 3 Company) that is in the developmental or research phases with no current license to operate nor sell the medical device products until medical licensing is satisfactorily completed per Food and Drug Administration regulations post inspection. Company A hired consultants representing Company B to develop, execute, compile, report and close Equipment/Test Method Validation/Quality Engineering protocols to support the pending patent in the United States.
The management of Company B (Small Company) instructed one of the performing senior level Consultant’s to write Test Method Validations (TMV) without any reference templates for each phase of the medical device manufacturing processes. The TMV template that originated from the senior level consultant was approved and Company A used it as a replacement for all their sites as the golden standard.
However, once the template was fully approved, the performing senior level consultant was no longer needed for his services and was subsequently replaced by a junior consultant being paid at 1/3 of hourly pay rates with respect to American market pay rates. As time went on when the client company was being inspected by the FDA, it was determined that the original designed template from the senior level consultant was misconstrued by the inexperienced consultant, which resulted in the company receiving 483’s for not adhering to their SOP’s and Templates. The company did not ensure the transfer of knowledge from the senior level to junior level consultant.
- 2. Any other elements or added value comments that can be factored in to ameliorate the long-term objectives toward corporate implementation should always be welcomed in an inclusive way as stipulated in the previous section.
- 3. The client allowing the flexibility of selecting a certain amount of time per day towards the attainment reaching the long-term objectives.
PRIORITIZING THE GOALS USING A SCIENCE RISK BASED APPROACH
Once short and long-term goals are identified, they can be prioritized using any of the scientific risk based tools including or not restrictive to FDMEA (Failure Design Mode and Effects Analysis); Matrix Approach; ASTM E2500-13; ICH-Q9 approach or simply setting business priorities using conventional tabular method. Whatever method you chosen, priorities must be well understood and agreed upon by both parties in the Client and Consultant Relationship.
IDENTIFYING THE TACTICS OR METHODS NEEDED TO EFFECTIVELY ATTAIN THE GOAL
After priorities are established sequentially or in parallel or in series or a combination of both series and parallel, it is recommended to ensure that the tactics or methods needed to effectively attain the goal involve the following:
- Developing a Checklist
- Posting goals above your desk or printing the goals and attaching the print outs in a close visual proximity of your computer/desk
- Providing hard or electronic copies to all stakeholders involved
- Writing notes on the fly during meeting with individual stakeholders during formal or informal meetings.
ESTABLISHING A MEASUREMENT SYSTEM/APPROACH: MONITORING THE PROGRESS ON HOW THE GOALS ARE BEING PERFORMED DURING THE EXECUTION PHASE
You can use a matrix table against the Management User Requirements or develop a metric against the Management User Requirements. You can also develop a metric for right first time scenario.
An example of the right first time metric is indicated below:
PRODUCING WEEKLY STATUS/FOLLOW-UP REPORTS AGAINST THE OBJECTIVES:
The following weekly conclusions are recommended to ensure a smooth transition towards reaching the objectives and Management User Requirements:
- Weekly Report
- Weekly Meeting
- Weekly Wrap-Ups including following up and projected tasks for the subsequent week
- Performance Evaluation (Client to Consultant and Consultant to Client feedback)
It is important for the companies to not only understand the attainment of completing short-term objectives but to understand the attainment of reaching long term objectives which will inevitably increase the probability for the company to increase their success in the long run.
Below is a partial list of Allan's publications. He has written 21 publications, while with one chapter pending in an upcoming 2019 PDA publication, and three other articles pending publication in Pharmaceutical Online.
He may be contacted at firstname.lastname@example.org.