Are you a manufacturer working in a regulated environment? Wondering if there is any value on bringing in a GMP consultant? Start with our 5 best tips on choosing and securing a budget for GMP consulting support for your business.
You’re a manufacturer of a product that gets sold and marketed in to a regulated environment. It could be pharmaceuticals, a medical device or even food. You’ve been relatively successful during previous inspections and feel comfortable with your current QA program – but there are new products and processes in the pipeline, and you’re not sure if you have the resources internally to manage an ever changing environment.
You’re not alone. We’ve been around for 30 years solving this exact problem for organisations in the Asia-Pacific region. Building a business case to bring in experienced consultants who can assist is one of the hardest challenges for a QA-Manager. You’re thinking “Isn’t this my job anyway? If I bring in a consultant my bosses will think that I’m not good at my job, or worse yet, my position is redundant….but I need assistance as they look to cut costs and resources for profitability”
When thinking about external help, most managers will do their best to solveproblems by themselves. In the process, shaving a few procedures here and there, until a problem arises from an inspection or product failure occurs. Our aim is to help QA-Managers win the business case to be better resourced and to get you thinking about asking the right questions, to ensure that your QA processes are watertight and you can be “Confident in Compliance”
Here are our 5 best tips to help you win the argument to be better resourced:
Tip 1: Experience matters
Under resourced? As opposed to spending time, money and effort looking for multiple short term fixes. It is better to hire just the one person who can bring a considerable amount of value in a shorter period of time. Greater experience means less on-board training, plus less of your time diverted from your main task of driving the team in the right direction. An experienced consultant will hit the road running, and will be able to see the issues even before they arise. One experienced consultant also means less overhead expenses (eg: WorkCover, Insurance, etc) as opposed to managing multiple junior external staff.
Tip 2: Bring in the latest “best practices” from yours and other industries
Experienced consultants are looking at best practices across a variety of industries and are inspired to bring in these practices whenever possible. This ensures that your processes will always be current. You will get the best ideas without having to leave the office. This in turn will improve your profile within the company.
Tip 3: Costs – understand what constitutes value
Most companies look for a quick short term fix and will opt for the cheapest option on the table. We understand that budgets are tight and fixed. However a project is a sum of many parts, and the QA department brings a considerable amount of value with providing business managers a risk profile which has a direct impact on future profitability. Experienced consultants can help raise the profile of your department and division so that you can secure a larger budget, sometimes even immediately.
Tip 4: Assess the reputation of the consultant
Reputations of firms are built on past experiences. Choose a firm with the greatest experience and reputation in your market and you will be assured that they will work hard to be part of your team. Reputation can be lost in a second, so if a company has been successful over a long period of time, then you can be even more confident when employing their resources. The outcome of the work will be tailored to your team’s specific requirements.
Tip 5: Be “Proactive” as opposed to “Reactive”
Most organisations decide to employ a consultant once an issue has arisen. This makes sense from a financial perspective as the problem is “known” and a budget can be assigned to “fix” the problem. However these costs increase the risk profile of the process, plus roll in to the final cost of manufacturing product, thereby reducing the overall profitability of the product and company. Companies often then look to cut fixed costs (usually staff) to address the downward pressures on margin. All in all an effective negative feedback loop.
By employing a consultant early on, risks can potentially be mitigated and a tighter risk tolerance can be applied to the project as a whole. Thereby giving business heads a more realistic profitability projection in the future.
Contact us if you'd like to sit down and discuss the broader picture of how a GMP consultant can be deployed to assist you.
