The use of quality assurance outsourcing solutions seems to be revolutionary to some, but is there really anything to be afraid of? Outsourcing is simply separating some of the functions a company conducts independently from the organizational structure and contracting them to other entities. This form of cooperation has been present in our daily lives and businesses for a long time. No one bats an eye at contracting an outside accounting company to meet their accounting needs. Not many companies decide to employ their lawyer while they can easily obtain legal services from a law firm. It’s just as easy to outsource challenges related to validation, qualification and measurement to an outside company specializing in these types of services. However, this topic causes many unnecessary fears and uncertainties. What benefits can transferring validation processes outside the company bring? In what situations should you investigate such support options? What should you look for when choosing the right subcontractor?
The priority of companies operating in the field of pharmacy and medical devices is in patient safety and the highest quality of products offered. That’s why tasks related to ensuring quality are one of the most critical in the entire company. So it’s no wonder that outsourcing these processes to an outside company can at first raise many questions. It’s good to seek answers to these questions and to learn about this cooperation model, which has been an important element facilitating dynamic development for western companies for many years.
In which situations can support from an outside company bring benefits? Is outsourcing an interesting solution only for small businesses?
One of the greatest advantages of receiving assistance from external consultants is that you use them only when you need them. If your company prepares a large project, additional specialists may be an excellent supplementation of your internal resources, in particular if the completion date of works determines the resumption or commencement of new production. The same applies in situations in which there’s a sudden need to re-qualify a machine or adjust to the comments made by an auditor. Instead of overloading a team that’s already busy with their ongoing tasks, it’s good to obtain support in certain areas.
This type of cooperation eliminates the burden of recruiting or training new candidates. In addition, you can rest assured that if a given employee is unwell or goes on leave, your subcontractor will suggest a replacement, which protects your work schedule and gives a feeling of security.
In small companies that don’t require full-time support from a validation specialist, the option of establishing cooperation with a contractor is ideal. You can take advantage of their support as you need, and that’s how you’ll be charged – only for the hours of consultations you use or the agreed part-time rate.
What should you look out for to be sure that the given contractor meets your expectations and performs the task you’ve entrusted with them adequately?
The references the given company has, are crucial in this matter. Relevant experience in the market and the opinions of our colleagues are valuable.
A good contractor will also provide you with information on the specific candidates who would execute the tasks entrusted to them. In addition to information on professional experience, you should also check the internal and external training the given company has provided for its employees. For you, this will guarantee that their knowledge and service performance are up to date with the latest industry standards.
The best contractors may recommend to you not only validation specialists but also professional team leaders and project managers. If you’re implementing a long and complicated project, or know that you’ll need ongoing support for a longer period of time (as is the case, for example, in maintaining a validated state), you can discuss the possibility of building a team that will comprehensively and professionally take over the assigned tasks, including planning, monitoring and preparing relevant summaries and reports.
A good subcontractor will present you with the appropriate procedures and solutions in this regard, but will also focus on the flexible tailoring of these to the specific needs of the project and business model of your company.
Another very important element is a reliable and feasible work schedule. An experienced partner will be able to, based on their knowledge and experience acquired in other projects, develop a plan containing information about the full scope, number of people, amount of time, and the equipment required to complete the project. They’ll also highlight the risks and crucial elements that you need to pay particular attention to. Based on this they’ll prepare their quote and the best form of billing for the progress of ongoing works.
The basis for this is the conversations that the future subcontractor conducts with the person who is responsible for the project and supplements the sending of technical documentation, plans or procedures currently in force in your company. So already at the outset, you must consider signing a confidentiality agreement.
The best introduction to preparing a detailed and precise quote can be an audit, during which the future contractor will check the state of documentation, procedures and applicable quality policy to then draw up a report with their opinion, list of potential problems and plan for further actions.
A company specializing in validation and qualification services should have its internal quality policy and be open to an audit by potential partners. If you don’t have time for meticulous inspection, you should send the service supplier a survey in which they will reply to key questions about the company itself as well as the quality policy it has in force.
In summary, if you decide to take advantage of the services of an outside company specializing in validation and qualification, you can significantly accelerate and improve quality assurance processes. A reliable subcontractor will help you to quickly implement a contract as per the schedule, optimize costs, eliminate the time and costs of recruitment, and flexibly react to market fluctuations. It can also turn out to be a real partner and provider of support. That’s why when choosing contractors, it’s important to check their experience, references, proposed candidates, schedule and approach to be sure that your collaboration will bring you optimal benefits.
