Computer-Aided Facilities Management - A Logical Trend
Two major organisational changes are part of the modern pharmaceutical industry scene. Firstly, mergers as companies seek to consolidate resources to get best returns on their R&D budgets. Secondly, a re-focusing on what is considered to be "core business". This may be Marketing, Research, Development, Manufacturing or any combination. For sure companies no longer wish to do everything in-house and contract manufacture, sub-contracting of QC analytical services, development services, and so on, is becoming the norm.
If we look at the "Value Chain", the core competence of a pharmaceutical company will lie along the path:
Core competence can be broadly described as:
Research: Identify potential drugs and therapeutic opportunities. Ensure patient safety.
Development: Develop reliable processes Establish QA standards Ensure process safety
Manufacturing: Cost-effective in accordance with GMPs and Regulatory requirements
Distribution: Effective, controlled delivery to the customer.
Pharmaceutical companies require skill-sets to work within and across the functional boundaries. Maximum benefits to the business are achieved when new products reach the market place in the shortest time possible. Even a few weeks' delay can mean the loss of millions of pounds in revenue.
Why then, with so much at stake, are those managers who are so crucial to the value chain so often distracted by a myriad of important but relatively peripheral issues which are part and parcel of the infrastructure of any large enterprise?
In the engineering field we have already seen the reduction in in-house resources as pharmaceutical companies acknowledge that project and construction management is definitely not a core competence requirement. More and more engineering houses
are negotiating "term-contracts" with their customers for the provision of small projects and maintenance services.
Manufacturing sites routinely outsource services such as catering, security and laundry. Many items of process and utility equipment are now serviced by the original or other suitably qualified vendor.
However, the consequence of this evolutionary rather than structural change is that outsourcing of services to manufacturing is often piecemeal and uncoordinated. Responsibilities can be split across the site management team. Scope of work is often based on vendor recommendations rather than client needs. Commercial terms are often general rather than focused on a quality of services and not always monitored to demonstrate true value for money.
Professional Facilities Management service providers take full responsibility for all non-core activities, naturally allowing clients to focus their resources where most value can be added.
The essential objective of Facilities Management is to systematically allocate the infrastructural activities to those for whom it is a speciality or their "core competence". (These include site security, maintenance services, laundry, catering, gardening, cleaning and a host of others.) In doing so, the pharmaceutical company concentrates its resources where it gives the greatest benefit to the business.
A + B
businessC – demand for support services C – activities are the A – business of the service provider "Services" are core business of the service provider Service Provider CAFM provider Efficient management and
document control for Technical Services
! Cost reduction
! Performance improvement
Concentration on core business of the company
As with anything new, there is a range of interpretations around the basic Facilities Management concept. Early versions of Facilities Management were basically office services: reception, cleaning and elementary maintenance. Later developments were driven by equipment and control system vendors who added routine servicing to their scope of supply. The added dimension of modern Facilities Management is to have systems and procedures which not only ensure that the service is provided but also that the quality and cost of that service is regularly monitored and reviewed. In the pharmaceutical manufacturing industry, there is the added dimension that work must be implemented and administered in a GMP-controlled manner.
The broad scope for Facilities Management can be defined as:
# The development and continuous execution of the PPM (Planned
Preventative maintenance) regimes for all M&E elements, production equipment, building fabric, external hard-standing and roads.
# Developing jointly with the Client the contractual strategy with the identified maintenance suppliers.
# Maintaining all records in accordance with the pharmaceutical industry
standards and the expectations of the MCA and FDA.
# Monitoring and maintaining essential spares and developing strategies for procurement.
# Formulating strategies for remedial action following a breakdown in any
The key to successful Facilities Management lies in robust management systems to control these activities. In order to cope with the quantities of information, an essential pre-requisite is tried and tested CAFM (Computer-Aided Facilities Management) systems.
CAFM systems enable the Facilities Manager to develop and issue work programmes, monitor all activities and prepare meaningful management reports.
The overview of a CAFM system is given below in Figure 2. Creation of necessary reports ! Monthly ! Quarterly ! Yearly Maintenance and Service expenditure
Material and goods expenditure
Service contracts Services with third parties
Projects, remodelling reinvestments
Energy and utilities
Statistical analysis Graphical representation
Special occurrences with comments
From the analysis determine required actions and improvements
Report for the Client
Structured to suit Client requirements
Report for the Facilities Manager
For controlling and supervising and identifying required actions
For any Facilities Management system to be effective there needs to be two phases of activity:
Step 1. Setting up the Facilities Management systems Step 2. Operational Phase.
The Set-Up phase requires a careful analysis of all the relevant activities. For each service area the Set-Up team will need to identify the tasks to be undertaken, the specification of each task and the performance expectation of the relevant system. For example, a service contract may be required for a number of Chiller Units. During the Set-Up phase all relevant documentation for the units will be assembled and reviewed. If not already detailed, the PPM requirements will be identified including tasks, materials SOPs and frequencies. (Initially, vendor data may be used but over time the Facilities Management provider will constantly challenge and review these requirements). A performance measure will then be allocated such as the percentage operational availability of the equipment. It has to be said that 100% targets across the board will be both unrealistic and prohibitively expensive. Again, over time, results will be monitored and evaluated so that the actual service level can be optimised for cost-effective performance.
This detailed analysis enables a realistic performance-based contract for the Operational Phase to be established between the client and the service provider. Typically, such an evaluation will take a team of Facilities Management specialists about 6 to 8 weeks to complete.
At the end of the evaluation, Facilities Management contracts can be drawn up to include activities such as:
− Ensuring adequate supply of quality-compliant utilities.
− Ensuring secure operation of HVAC systems.
− Ensuring secure energy supply.
− Ability to respond rapidly to a problem (recognising that a substantial portion of the workload is reactive).
− Promptly responding to and repairing minor discrepancies in the facility.
− Developing and executing a system of regularly scheduled maintenance actions to prevent premature failure of the facility and its systems and components.
− Completing major repairs based on lowest life-cycle cost.
− Operating the facility utilities in the most economical manner while providing necessary reliability.
− Providing for easy and complete reporting and identification of necessary repair and maintenance work.
− Performing accurate cost estimating to ensure lowest cost solutions to maintenance problems.
− Accurately tracking the costs of all maintenance work.
− Scheduling all planned work in advance, and allocating and anticipating staff requirements to meet planned and, as far as possible, unplanned events.
− Monitoring the progress of all maintenance work.
− Maintaining complete historical data concerning the facility in general, and equipment and components in particular.
− Continually seeking workable engineering solutions to maintenance problems.
− Identifying design and complete improvement projects to reduce and minimise total operating and maintenance costs.
Although many Facilities Management activities do not have a regulatory dimension it is of paramount importance that those that do are managed in a GMP-compliant manner.
Pharmaceutical clients are understandably concerned and cautious about any activity carried out by third parties on GMP-sensitive systems. This includes Purified Water and WFI Systems, Clean Steam, HVAC and Sterile Compressed Air. It can also include standard process equipment such as Washers and Autoclaves. Given the principle of the client concentrating on core activities, it is less usual for specialist process equipment to be included in the Facilities Management contract.
In the case of GMP-significant equipment, the performance criteria are necessarily more stringent and will have been established for the Performance Qualification of each system. All work carried out on such systems will be in accordance with client-approved SOPs and any system modifications will be subject to rigid Change Control procedures.
The CAFM system will need to embrace requirements such as: • Installation Qualification
• Operational Qualification
• Performance Qualification
• Standard Operating Procedures
• Change Control
• Training Records
• Good Automated Manufacturing Practice
• Equipment History Files
The requirement for integrating these activities within a CAFM system is illustrated in Figure 3.
Change control documentation
Integrated Documentation Systems
Continuous documented proof of Personnel activities
Equipment status Fault Analysis, etc
system logs log books certificates maintenance records activity records reports daily reports regulatory aspects correspondence maintenance instructions warranty management equipment deficiency list tracking of damages
order handling requests for material
delivery notes Systems documentation Regulatory compliance Documentation Responsibilities Structure of personnel Maintenance plan Supplementary services Inventory list Regulatory authority: Relevant to inspections, Manufacturing approvals Product release Projects Modifications Improvements In consideration for: FM Internal Reporting: Documentation of the facilities
activities Comprehensive documentation processes In consideration for:
Ultimately, the major benefit stems from the business opportunity given to clients to focus their staff where they add most value. However, a commercial justification can be made for Facilities Management in isolation. By monitoring key operational parameters such as equipment availability and performance criteria, the quality of maintenance service can be judged. This can lead to review of activities, procedures, maintenance frequency, suppliers, etc. Ultimately, this will result in a reduction in the overall cost for a table or improved level of service.
Preventative maintenance Number of Faults Availability
In summary, the benefits of CAFM are: # Efficient maintenance service.
# Optimisation and control of overall maintenance costs. # Meaningful reporting of all Facility Management activities. # Control of small works projects.
# All activities in a GMP-controlled environment. # Proper application of Change Control procedures.
# Permitting company management to concentrate on core business activities
Reduction in maintenance hours through improvements to