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Employed as a Compliance and Regulatory Affairs Officer at AndersonBrecon I am responsible for actively pursuing the streamlined introduction of new products within project timelines, setting up and maintaining Regulatory files, Preparation of annual Product Quality Reviews and general administrative duties.
Task
Recently AndersonBrecon UK was contracted to import and release a brand new medical product on behalf of a new client. I was tasked with the responsibility of ensuring that the project is managed and all of the regulatory documents are in place to allow us to release the product by February 2013.
To list a few of my responsibilities; Implement new procedures, develop a process flow, write the Technical Agreement, collect Regulatory information and monitor the progress.
Organisational Targets
The targets are identified and set by the following company statements
Vision – To be the preferred partner to healthcare providers and pharmaceutical manufactures Mission – To improve patient’s lives by delivering innovative products and services that drive quality and efficiency in pharmaceutical care.
Values – Accountability, collaboration, customer focus, innovation, integrity and passion.
These statements are referred to and implemented from the early stages of negotiating and securing the deal, right the way through to releasing the finished product to market.
The above Targets set by AndersonBrecon were identified using a SMART plan.
Specific – AndersonBrecon UK needs to build a good relationship with new clients in order to develop, grow and standard out in the market place. The goal is to proved product to the Market on time and in full. Departments involved in the task in hand are Regulatory Affairs, Warehouse, Laboratory, Qualified Person (QP) and compliance.
Measurable – As a company we need to ensure that the product is released in time for the Product launch date 08 February 2013. Weekly progress meeting are held with the client in order to discuss any issues, delays or concerns. Three batches require import laboratory testing prior to QP release to market.
Achievable – All targets set when seeking new contracts must be realistic and profit making.
Relevant – It is imperative that AndersonBrecon UK help develop new products alongside new clients in order to meet the company’s vision “To be the preferred partner to healthcare providers and pharmaceutical manufactures”.
Timescale – In order to ensure this task is completed on time all the departments involved need to work together and managed in an efficient and organised manner.
Setting Team Objectives from Organisational Targets
SMART Plans were used to set the objects.
Analytical targets:
Specific – The client provided AndersonBrecon UK with approved analytical methods in order to aid the laboratory with the import testing.
Measurable – All analytical tests will be listed, allocated and assigned to the most appropriate person within the laboratory. Expected completion dates will be set, weekly progress meeting held to monitor the project and the associated tasks. The goal is to complete all the tasks by the 08 February 2013.
Achievable – AndersonBrecon UK is a consulting services company which specialises in developing new products therefore it has all the relative resources to hand to ensure this is achievable.
Relevant – Every task listed will need to be relevant to the task in hand. Due to tight time constraints any irrelevant tasks will result in wasted time.
Timescale – It is imperative that the analytical tests are performed and results reviewed in time for the product launch and therefore it is extremely important that all the tasks planned and allocated are completed on time and in full.
Regulatory Tasks:
Specific – The client provided Regulatory documentation, licensing documentation, marketing authorisation documentation, manufacturing batch records and audit reports in order to setup regulatory files and to aid the QPs in the release process. Regulatory file is completed and up to date and a risk assessment of the supply chain is performed. The short timeframe is the only likely constraint.
Measurable – All tasks will be listed, allocated and assigned to the most appropriate person within the Quality department. Expected completion dates will be set, weekly progress meeting held to monitor the project and the associated tasks. The goal is to complete all the tasks by the 31 January 2013.
Achievable – AndersonBrecon UK is a consulting services company which specialises in developing new products therefore it has all the relative resources to hand to ensure this is achievable.
Relevant – Every task listed will need to be relevant to the task in hand. Due to tight time constraints any irrelevant tasks will result in wasted time.
Timescale – It is imperative that all the regulatory documentation is received from the client and reviewed by AndersonBrecon’s quality department
prior to the review of the three batch packaging and manufacturing records. Any delay here will have a knock on effect.
QP services Tasks:
Specific – The three batches will be imported from the USA to AndersonBrecon UK where it will be stored until satisfactory completion of Analytical testing and regulatory files in place. Once these tasks have been completed A Qualified Person (QP) will have to review and the release the batches before they can be placed on the European market.
Measurable – All tasks that require QP input will be listed, allocated and assigned to the most appropriate person. Expected completion dates will be set, weekly progress meeting held to monitor the project and the associated tasks. The goal is to complete all the tasks by the 05 February 2013.
Achievable – AndersonBrecon UK is a consulting services company which specialises in developing new products therefore it has all the relative resources to hand to ensure this is achievable.
Relevant – Every task listed will need to be relevant to the task in hand. Due to tight time constraints any irrelevant tasks will result in wasted time.
Timescale – It is imperative that the three batches are released in time for the product launch and therefore it is extremely important that all the tasks planned and allocated are completed on time and in full.
The Action Plan
To ensure all tasks are covered, allocated and delivered on time I decided to construct an action plan
Monitor and Control the Activity
It is vital that good communication is maintained throughout the activity to ensure it is a success. The above action plan was made readily available to all those involved in the project and instructions were given to mark when completed and make any necessary comments in order to keep track of the progress made. Weekly teleconferences with the client were organised and arranged to provide updates and to discuss any issues or concerns.
Internal meeting were held on a fortnightly basis to monitor the progress and to ensure the project is on track, at these meeting the organisational targets are discussed along with the objectives. Key members in each department were identified and considered to be the main contacts regarding this project as this would make the process more efficient and make communication easier.
How to Allocate Work to the Team members involved
Even before the physical stock arrives at AndersonBrecon Technical agreements need to be written and put into place, the client’s details along with product details need to be added to the ERP system. Once the three batches of product have been shipped to AndersonBrecon we need to ensure that all departments involved have all the resources required to complete the activity. Samples from each of the three batches need to be submitted to the laboratory as analytical testing can begin. I anticipate it taking 3 months to complete all the tasks associated with this project. Regulatory, Laboratory, Customer services and a qualified person are required to ensure this project is successful.
All tasks will have to be specific and allocated to the best person who possesses the necessary skills and knowledge to complete the task efficiently and effectively. The tasks will be allocated in the following manner:
o Qualified Person – Responsible for reviewing the batch packaging records and authorising the release of the product to the European Market. Audits will have to be performed at the manufacturing sites involved. All these tasks can only be performed by a QP as this is a legal requirement. o Compliance and Regulatory Affairs Officer – Responsible for collecting all the regulatory and marketing authorisation documentation to allow the QP to perform the release, Technical Agreement will need drafting and approving by both parties and a risk assessment carried out on the supply chain.
The regulatory department is most suited to these tasks because they have the knowledge, expertise and contacts to ensure they are completed on time. o Analytical assistants – will be responsible for executing the analytical tests and presenting the data to the QP to ensure the product meets specification. As you can appreciate the laboratory is the only department equipped to perform such tasks and who better to perform the tasks than the Analytical assistants. o Project manager – To ensure all costs are captured, communication with the client is maintained, the project is monitored and acts as a key representative of the project as a whole. This person is most suited to these tasks because it’s within their remit.
Assessing and supporting the team’s performance
A project manager was assigned to lead the project, it was there reasonability to assess the team’s performance by arranging fortnightly Internal meeting to bring together all the departments involved where issues can be discussed as well as providing an opportunity to monitor the progress and to ensure the project was on track. An open and friendly atmosphere is always encouraged in these meeting as this enables all department leaders to discuss issues openly and freely so support can be arranged and given as required.
As previously mentioned the aforementioned action plan is made readily available to all the individuals involved, they are instructed to make sure the plan is updated on a regular basis so a visual representation of the status of the project and it tasks can be monitored. The team’s performance can be measured by comparing the actual completion dates with the predicted completion dates set at the beginning of the project; if tasks are completed earlier it’s safe to say the team is functioning efficiently and effectively.
Because of the companies resources should any support be identified and required it can be made readily available. Support from the client will be paramount to ensuring some the tasks are a success therefore weekly teleconferences were held with them.
Dealing with a variance from the planned activity
Identifying
Many problems can occur which result in a variance from the planned activity, to list a few: o Sickness – Should a member of the team fall sick it could affect deadlines and result in the product not being released on time for its market launch date o Analytical test failures – Out of specification results may be encountered when reviewing the results from the analytical tests. Is this was to happen additional tests would be required causing possible delays. o Transport issues – The stock could get damaged in transit from the USA to AndersonBrecon, Temperature excursions may be encountered compromising the product or even delays in transport causing a late delivery. o Issues with the subcontractors – Delays may occur with our analytical subcontractors or they may experience problems when running the analytical tests, both of these will cause a delay in the release date.
Overcome
The aforementioned problems can be overcome as follows o Sickness – Should sickness be an issue as indeed it was, overtime would have to be concerned to ensure that the working hours lost are made up to ensure we deliver and maintain on track, as this is cruel when working to tight timeframes. o Analytical test failures – Should any out of specification results occur, and unfortunately they did, additional tests would have to be performed immediately and the client informed. There is no way of overcoming this problem, tests take time and cannot be expedited or rushed as this may lead to further complications and delays.
o Transport issues – The likelihood of the goods getting damaged can be reduced by using an approved hauler. If we request a copy of the stability data for the product upfront and should any temperature excursions be experienced we can easily assess the incident and come to a sound conclusion without wasting too much time. o Issues with subcontractors – To overcome any problems raised by the subcontractor we would have to communicate efficiently and effectively and work together sharing each other’s knowledge to overcome the problem in hand quickly and accurately and avoid any delays.
Ways of involving the team members in identifying ways to improve performance AndersonBrecon have a number of methods for promoting performance improvements such as a suggestion box were all employees are urged to complete suggestion forms which are reviewed and considered by the board of directors. For the last 12 months the company have been awarding “the power of 1 award” to employees that perform to a high level, this persuades employees to improve performance because of the financial gain involved.
The Company also invests heavily in training there staff are selected to participate in various courses such as the ILM Leadership and Management course in order to increase peoples knowledge and understanding. Continuous improvement is always welcomed by the company, a large number of employees have completed their Kazan six sigma training in order to try and improve performance and efficiency within their teams.
Throughout this project all members involved are encouraged to communicate their thoughts and views to the management team in order to ensure the best plan of action is applied. Its very important that all members feel valued and a part of the team as this in its self increases performance.
