The selection of an experienced build and test partner is critical to the success of any new complex equipment manufacture. This article examines the selection criteria that R&D, product development and pharmaceutical organisations should employ to ensure their partner of choice can really deliver.

There are of course, obvious criteria by which potential suppliers should be measured. Facilities, experience, technical capability, quality assurance procedures and track record are all factors which should be considered.

But that’s not all. There are ‘softer’ issues to consider too. How will the project be managed? Is the supplier a ‘can do’ company? Do they understand the end game? Will they create more complexity or simply get the job done?

The need to assess the values of your partner.
The values of the supplier are an often overlooked yet important consideration. A motivated partner will bring to its customers a more proactive relationship that can often make the difference between success and failure. A close relationship will deliver all kinds of benefits: faster build time, effective planning, open visibility on costs and validated testing that provides confidence that the end product is fit for purpose.

There must be an attitudinal link between the manufacturer and the customer, which is based on a mutual commitment to developing and building a better end product, on time and on budget.

This customer focus should be a cultural attitude that embraces every aspect of the suppliers business, not just at the personal relationship level. This can be demonstrated in a number of ways, but in essence, a manufacturer who is constantly striving for excellence, who applies common sense, who is committed to deadlines; these are the indicative values of an organisation that puts customers first.

Matching skills
Consideration should also be given to the structure of the project team. Ideally, both organisations should have complementary teams where a level of technical expertise is matched on both sides. This means that design engineers can talk to design engineers, project managers can talk to project managers and so on. Without this ‘meeting of minds’, tasks can be slowed or over complicated simply by misunderstandings. Look for a supplier who can demonstrate a broad range of team working and communication styles that suit your organisation.

Regulatory compliance and quality are key factors in any selection process, but again, the consideration starts with the needs of the customer. Clearly the regulatory issues are much more robust for equipment that comes into contact with an active pharmaceutical ingredient. Equally, fitness for purpose is a key measurement; there is little value in appointing a class 10,000 clean room manufacturer when actually what is required is a non clean-room manufacturing environment.

Continuous improvement
Suppliers should provide fact based planning rather than reactionary decision making and should be able to guide customers through the product development process in a pain free and efficient manner. They need to provide a platform for continuous improvement throughout the lifecycle of the product. The improvements could and should be wide ranging, from consistently improving the supply chain to continually reducing waste, from yielding higher quality standards to a lower cost of manufacture over time. More than anything else, suppliers need to be delivering intelligent manufacturing solutions.

Improvements can often come from customer field visits.

Of course manufacturers also have a duty to ensure they offer their partners the best possible value. In essence, this requires them to apply a philosophy of continual improvement throughout their business so that products are manufactured in the most efficient, effective and value driven way possible.
Too often it is thought that cost savings can only be achieved by reducing profit margin but this route is neither sustainable nor indeed, realistic. Manufacturers must seek out efficiencies in other ways, primarily through process improvement and waste elimination. There may also be efficiencies in product development, though the level to which improvements can be made is entirely dependent on the regulatory constraints for that particular product. Many improvements can and will come field visits – there are notable examples where the Engineering Services Managers who built the equipment are the same people who install them, train the operators and provide service and support. The intimacy with which they understand each machine makes the service seamless, providing everyone with absolute confidence that they are being well supported and of course able to interpret and act upon customer/user insight.

Eradicating bad days
‘Bad days’ can potentially have a long-term impact on the viability of the end users business. Whether bad days are derived from unforeseen ‘glitches’ or more systemic process issues, without an appropriate and timely resolution the ultimate sanction can be significant business interruption and loss of revenue. The prevention of such ‘bad days’ is best served through a structured problem solving methodology that delivers the necessary improvements in business process. By identifying the underlying cause and establishing best practice to ensure the solution remains in place, the number of bad days can be radically reduced and systemically eradicated.
The maintenance of quality does not just sit within the four walls of the suppliers manufacturing facility. A robust, qualitative and ongoing assessment of the whole supply chain should be evident. There is little point in controlling quality inside the plant if the standard of the quality systems within incoming materials and component suppliers are allowed to compromise efficient manufacture. Manufacturers should be able to demonstrate their ability to qualify a supply chain and work from an approved supplier base where incoming quality is assured.

Reducing cost
Cost reduction programmes are often an obvious starting point in the creation an ongoing programme of continuous improvement. The strategic target for all manufacturers should be to minimise waste in the business and an overall reduction in operating costs. The commitment to waste reduction should run right throughout the business and whilst management focus is important, it is often “employee buy-in” that is the decisive factor. This well-rounded approach contributes to greater consistency in people and process, ensuring an all-round better service for the customer.

Flexible manufacturing
In scaling-up rapidly, the transition required to deliver the necessary production levels while maintaining quality standards can be complex and ‘stepping-up’ production with an acceptable level of risk requires careful and experienced management.
Enlightened suppliers will offer a scaleable manufacturing approach. As we have identified, effective lifecycle management can contribute positively to the commercial success of the equipment throughout its life, but is perhaps most critical when volumes begin to fall. Great importance should be placed on the capability to manufacture products in the most appropriate and sustainable way throughout life. Scalable processes and flexible manufacturing facilities should be employed during the course of development and beyond.

As the product reaches maturity and moves toward the end of its life, this scalability again becomes important. As production volumes start to decline an intelligent manufacturer can allow for the introduction of different scheduling methods and perhaps switch from full-time to ‘campaign’ manufacture.

Conclusions
The key criteria for the selection of a manufacturing partner should be based on their competencies and demonstrable track record in building and testing complex manufacturing equipment. Only by a comprehensive understanding of all the factors involved are manufacturers able to create products that are fit for purpose. Customers should expect to see evidence of the manufacturer’s success in developing other equipment.
The investment that design houses and R&D departments make in developing new equipment is considerable. In order to ensure that the end product has the best possible chance of sustained and profitable success, the choice of manufacturer is critical.
Customers need to choose a partner they can rely on. A partner that will never find themselves on the critical path of the project. Customers should also demand a partner who can add value; experience and expertise counts for a great deal. Without the necessary experience, projects can be delayed, budgets can be increased and the end product may not fulfil its purpose.

So in conclusion – expertise is fundamental. Experience is critical. A culture of ‘can do’ is paramount. Without these core values, your manufacturing partner may not be able to deliver you the product you need on time or on budget.

The key criteria for assessment
1. What kind of relationship are you looking for?
2. What is the level of compliance and quality needed?
3. How complex is the product?
4. Has the supplier got a track record in your business?
5. Can they demonstrate success with similar products?
6. Is value being added throughout the project?

Julie Dean, Managing Director of Nexus Intelligent Engineering.

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