Re-Dimensioning the Role of GxP Service Providers

Why might your outsourced services fail, despite having hired recognized companies? 

The health industry, for example, is responsible for delivering products to the population. The quality attributes of these products must be maintained because those who acquire them expect to maintain, recover or improve their health as a result. For this reason, the various rules and regulations establish Good Manufacturing Practices to guarantee that the processes and products resulting from them will not represent risks to the health, safety or integrity of the patients and users of these products.

Throughout the history of good practices, the role of service providers has grown in importance due to the increasingly specialized needs related to processes and the change in business paradigms.

Unlike the suppliers of supplies and equipment that have always had their fixed place in the value chain, with well-defined deliverables and attributes, service providers have a different dynamic. Their deliverables, activities, control and measurement of results require a different approach for their correct evaluation. Often, their work can go unnoticed, overshadowed by the results of the company's internal staff or the overall result of the project, despite the fact that this result and the activities that led to it depend on or work as a result of the service provided.

There are service providers for practically each of the Good Manufacturing Practices existing in the regulations:

• Maintenance of production and laboratory equipment

• Calibrations

• Validations and qualifications

• Stability studies

• Chemical analysis

• Storage and transportation

• Audits

• Quality consultancies

• Training and qualification of personnel cloud infrastructure

• Technical support to systems

These providers can cover types of services as varied as:

• Consultancy

• Engineering and construction

• Execution of operational, quality, validation, verification and maintenance activities

• Technical support

• IT services

• Cleaning and sanitizing

• Logistics

• Commercial tasks

• Regulatory affairs management

• Intellectual and legal property

It is common to think that a good outsourced service depends on aspects such as the provider's experience, its infrastructure, economic stability, curriculum, number of people available is only half of the equation. The other variable depends on the same proportions of the contracting companies and their responsibilities when contracting a service.

Behind a good outsourced service there are many factors that are not always visible to those who hire it. Sometimes this invisibility is a product of the lack of communication between the end users of the service, the purchasing and quality area of ​​the company or in other cases, it may simply be a lack of established requirements.

In any case, it is important to start from clear requirements considering these three perspectives, which allow making the best decision in the selection of suppliers, which is where the responsibilities of the contractor begin. It goes without saying that communication between these three entities is also necessary to obtain good results.

A good service provider will have several support processes designed to collectively raise and maintain the level of confidence in the success of the service provided:

• Quality management system and policies that support the evaluation of results, standardize your processes and promote continuous improvement

• Automation of processes such as the QMS, the evaluation of results or the elaboration of value proposals

• CRM for management and follow-up appropriate to customer needs

• Control systems and measurement of services such as project management, service procedures and quality surveys

• Qualification of the personnel so that the technical level, aptitudes and attitudes of the assigned personnel are standardized

• Training schemes not only in technical aspects of the service but also in the so-called soft skills for constant staff development and better adaptation to the conditions required by an adequate service attitude

• Activity support infrastructure

• Schemes of motivation and well-being of the personnel with an adequate work culture that allow their continuity in the company, reduce turnover and promote the maintenance of service standards

All of the above factors have a cost, but also add great value to the provision of the service by increasing the probability of its success; however, the previous ones are not of much use if the receiving party of the service does not have the capacities to get the most advantage from them.

These factors must be considered and understood by users, buyers and quality units for the definition of adequate costs, comparison between suppliers and the definition of references for the concepts of "expensive" or "cheap." You always have to compare apples to apples and pears to pears. Recommendations, reputation, testimonials and quality history can have a specific weight when making hiring decisions.

Some paradigms that require a review by service contractors may be that:

• The service provider is hired to provide a result without taking time from the company's staff

• The subcontracted personnel is the responsibility of the companies to which they belong

• Outsourced staff must be able to find solutions on their own

• Price is the only thing that counts, all providers are the same

• The provider is only there to serve us

In the current times where companies need to increase their efficiency and monitor the use of their resources, the role of service providers is crucial to increase the efficiency and effectiveness of companies, but equally important is the paradigm shift for management of these outsourced services.

There is an increasing tendency for companies to rely on external service providers to carry out specialized support activities, allowing the business to better focus its resources, efforts and minds on its core business objects.

Some aspects that in my experience are necessary for service contracting companies to take into account are the following:

• There should be well-defined and documented responsibilities between service providers and users

• Adequate communication channels must be established

• Often the quality of the suppliers' results depends in turn on the quality of the information provided to them by the contracting company

• Both parties must know and agree in advance the work route, the times and deadlines for the completion of the activities as well as the deliverables of each stage

• Transparency in the flow of information related to meeting the objectives of the service is mandatory

• Maximum document and deliverable review times should be established, as well as the mechanics that allow avoiding endless reviews or requests for different and even contradictory modifications among users

• In the same way that when new personnel enter a company, outsourced external personnel must be apprised of the procedures, policies and instructions necessary to act correctly within the client's facilities

• The hierarchical and organizational structures of the contractor and the clients should not be respected as a matter of convenience: both are important and must work in coordination toward the objectives

• Failure to provide the provider with adequate and timely feedback on the quality of service, prevents important decisions from being made to correct the course at critical moments

In summary, we could say that the success of outsourced services depends on similar proportions between the capabilities of the providers and those of the contracting party. A service provider is hired to be part of the solution, not the problem. They are a tool that, used appropriately and responsibly, makes them efficient and raises the quality of the expected results to fulfill the contractor's objectives.

To finish, it is not enough to select a good service provider. It must be considered as part of your company and is a crucial part in maintaining its value chain. As with the staff of your company, their motivation, feedback and monitoring greatly enhance the results.