Professional Documents
Culture Documents
Project monitoring:
- Tracking progress
- Comparing actual progress to the predicted or planned one
- Analysing impact
- Making adjustments (without compromising with the objectives of the project)
- Keeping a check on budget utilisation
Reporting:
The project manager has to make a comprehensive report at the end of the project
. The report has to be presented to the top management of the company or the pla
nt. Normally, a project report will be a summary of all the activities taken by
the project management team to implement the planned project. It gives the neces
sary information and inputs to the top management for future decisions so as to
make better planning for the future projects and identify the areas of concern.
Therefore, managing of a project can be considered as successful if the project
objectives have been achieved:
- Within the given time frame
- Within the allotted budget
- At the desired performance/technology level
- While utilising the assigned resources in a better way (i.e., both effectively
and efficiently)
The project planning work is done by the project manager. However, the objective
s part of the planning will be decided by the top management of the company or t
he plant depending upon the nature of the work.
Potential benefits
The potential benefits from project management are the following:
- Identification of functional responsibilities
- Avoidance of continuous reporting to and monitoring by the top management
- Identification of time limits for scheduling of work
- Measurement of accomplishment against plans
- Early identification of potential problems
- Improvement in budgeting of funds and allocation of resources for future plann
ing
- Knowing when the objectives can be met or even exceeded
Obstacles
The project management can become successful only by overcoming the following ob
stacles:
- Complex nature of the project
- Customer's special requirements i.e., other than the expected ones or the rout
inely asked ones
- Changes in the organisational structure and the project management team
- Project risks
- Changes in technology
- Changes in the desired outcome or specifications while working for a pre-deter
mined project
- Change in the priority status of the project
The team decides about the following plan of action for successful technology tr
ansfer:
1) The formulator has to supervise the manufacturing process on the shop floor a
nd educate the production personnel about the product developed and important as
pects of the manufacturing process. He has to prepare the master production reco
rd (MPR) giving details of manufacturing method, specifications of raw materials
, packaging materials, in-process controls and finished product. He will also pr
epare a stability study protocol to conduct stability studies, a critical requir
ement before commercialisation.
2) The analyst shall supervise the analysis of all the inputs going into the pro
duct (including packaging materials - both primary and secondary), in-process sa
mples' analysis and finished product's analysis. He has to educate the QC person
nel in the process. He has to prepare a detailed procedure to perform the analyt
ical method/s developed by him specifically for the product.
3) QA has to ensure compliance of manufacturing process and analysis to the docu
ments prepared by the formulator and the analyst. Any deviation will be noted by
QA and suitable measures taken in consultation with concerned departments so th
at the same problems can be avoided during routine production campaign. They wil
l ensure that the raw materials used in the technology transfer batch will compl
y to the specifications given by FD.
4) Production department will be absorbing the technology of a new product and u
nderstanding the technicalities so that they understand the manufacturing proces
s very well and production campaign will be smooth after commercialisation of th
e product. They will also co-ordinate with stores and purchase departments for a
vailability of raw materials.
5) QC department will be absorbing the technical know-how of the analytical meth
od. This will help them while analysing the samples of raw materials, in-process
materials and finished product when the product is commercialised.
6) Validation department will prepare protocols for both process evaluation as w
ell as method evaluation for the purpose of validation. They will prepare the pr
otocols in association with FD and AD respectively.
7) Regulatory affairs will make use of the data obtained from the technology tra
nsfer in suitable documents required to be given to regulatory authorities in th
e countries where the company intends to file the product. This will prove that
the scale-up activity has been done in a systematic way. RA will also review the
MPR and the analytical method with the intention of ensuring that both formula
and process of the new product have been the same from lab scale batch to techno
logy transfer stage.
8) Engineering department will ensure smooth operation of machinery and utilitie
s. They will also become aware of any special requirements like temperature and
humidity limits.
9) The timelines are fixed i.e., beginning date and the last date for taking tec
hnology transfer batch on the shop floor and analysis work of all samples. Time
lines are given fixed for the unit operations as well.
Progress of technology transfer will be monitored by none other than VP/GM. The
team constituted by him will make available daily report to him. Comparison of a
ctual progress to the planned one will be made. Trouble shooting work if any, wi
ll be taken very seriously because, filing of the new product may get affected b
y it. It will also be helpful while running production campaigns.
Finally, a comprehensive report will be prepared by the FD manager (or QA manage
r in some companies) giving details of technology transfer work performed. All t
he team members will contribute to the report based on the responsibilities assi
gned to them. This report will have detailed review of the total work done for t
he purpose of technology transfer and an assessment of the same.
Typically, a report on technology transfer includes the following sections:
1) Stated objectives (with which the process of technology transfer started).
2) The envisaged plan of action and a copy of different protocols like process v
alidation protocol, analytical method validation protocol, stability study proto
col etc.
3) A critical view of the whole process of technology transfer with stress on co
mpliance to the pre-fixed parameters.
4) Process deviations if any and the remedial action/s taken and the effects of
the same on product quality and process.
5) Analysis of results with the intention of comparing the stated objectives wit
h the achieved objectives.
Reporting is very important because based on this report, VP/GM will decide abou
t future course of action such as recommendation to the top management of the co
mpany regarding filing of the new product in various markets (countries). It wil
l also establish the credibility of the process and the formulation developed by
FD and the analytical method developed by AD.
Thus, project management may be employed to do systematic work and converge the
expertise available in different departments. Many times it also happens that pe
ople use the principles of project management without being aware of them and at
tribute the successful outcome as a matter of luck. Nevertheless, project manage
ment is a tremendous tool for successful execution of short time assignments of
strategic importance and also overcome the obstacles of departmentalisation and
bureaucracy.