Why Use a Consultant for QA/QMS, Regulatory Affairs, or Other Purposes?

Why Use a Consultant? (vs. in-house) for Regulatory Affairs (RA), Quality Assurance (QA) or other

Weighing the numerous pros & cons of bringing in a consultant vs. tackling it all in-house? Why reinvent the wheel, when ICS Inc. has most likely done the exact same thing for other companies in the past? (or at least something rather similar). Even if it’s a rather unique process, as part of our own Quality Assurance (QA) program / Quality Management System (QMS), a section of our Change Control protocol eveWhy contract a consultantn includes an SOP for developing new SOPs (along with their associated quality records – forms, checklists, tables & labels).

A reputable consultant should be able to get you through the process with less pain (as we bare that aspect, so you don’t have to), while your staff & management can focus on the tasks on hand that they are experts in. We can share that burden to whatever extent you desire. We can take it all on (doing the baiting, fishing & skinning), or we can also train your key personnel to perform this in-house (teach them to fish). Or some combination of the two. It’s your choice.   Contact us so we can mutually figure out to best assist you.

There are many reasons why your organization could take advantage of the expertise of a consultant, such as for Compliance to Regulations, problem solving and project management. Some of these reasons are:

Government Regulatory Compliance

Objective Review

Third-Party Request For Problem Identification and Resolution

Executive Assistance

In-House Education

Temporary Assistance

Surviving A Crisis

Initiating Change

Obtaining Funding

Selecting Personnel

Dealing With Internal Personnel Difficulties

Delay Tactics

Socio-Economic And Political Changes

 

Government Regulatory Compliance

Government regulations at all levels are constantly changing, and companies are frequently not prepared or trained to comply. Consultants may be retained to provide expertise to assist a company in complying economically, efficiently, and with the least amount of trauma to the organization. Please refer to our Regulatory Affairs (RA) main page and our Quality Assurance (QA) main page.

Objective Review

Consultants are retained as impartial advisers without any vested interest in the outcome of the recommendations. Internal staff may not be able to see the problems or may not be sufficiently objective. A consultant can perform a competent and thorough analysis of the issues. It is easier psychologically for personnel to adapt to external advice, rather than the internal advice of someone who may be acting out of self-interest. For example, please refer to our QA Auditing page.

Third-Party Request For Problem Identification and Resolution

Companies are naturally concerned about any signs that put their investment at risk. They may need to know whether the problems are related to administrative, personnel, financial, market, or product difficulties and how the problems can be solved. Only an outside consultant’s opinion would be credible.

Executive Assistance

An executive who is aware of his or her personal limitations may request that a consultant review a problem situation, provide advice on how to deal with it, and possibly follow up with implementation.

In-House Education

Consultants are hired to provide in-house training to keep staff informed of new management and supervisory techniques or technical knowledge and to improve employee morale. Please refer to our QA & Regulatory training page.

Temporary Assistance

To supplement skills in your organization by hiring trained, proven, motivated consultants on a short-term or long-term basis. Consultants may be hired on a project, seasonal, or new funding basis.

By hiring consultants, you do not have to contend with the training, instruction, and long-term commitment for salaries and fringe benefits entailed in hiring a skilled employee. Recruitment costs alone for a skilled employee can be considerable and cannot be justified for short-lived or cyclical need. Consultants are independent contractors and therefor no tax deductions or fringe benefits are involved.

Surviving A Crisis

A business owner suffering from serious business problems may seek an outside consultant to investigate the causes and recommend solutions.

Initiating Change

A consultant can act as a catalyst for stimulating ideas in a highly structured organization that otherwise might be resistant to change due to its size, bureaucracy, and institutionalized nature.

Obtaining Funding

Many nonprofit organizations, small- and medium-size businesses and research organizations need assistance in obtaining grants or loans for their continued survival. They may lack the expertise, ability, or time to research the availability of funding and prepare a persuasive application. Consultants with an expertise in this area act as advisors or agents. Please refer to our Funding page.

Selecting Personnel

A client may hire a consultant for recruitment of key technical staff / management. The consultant is looked upon as being independent and unbiased with the expertise and time to selectively screen and recommend prospective candidates. Please refer to our technical personnel recruiting page.

Dealing With Internal Personnel Difficulties

Outside consultants are retained to review and make recommendations on internal structure, for example, consolidation of departments or services, or elimination or redundant processes, employees, or executives. The consultant’s report provides the rationale for making the decisions. The consultant then leaves and is not effected by the decision.

Consultants can also be used to resolve conflicts between various levels of management, or between departments. The consultant plays an arbitrating or mediating role that permits frustrations to be expressed so that energy can be directed toward constructive resolution.

Delay Tactics

Consultants can be hired to perform research studies, which take the pressure off a company that is being exposed to public or government scrutiny. This also permits the organization to use the excuse of a consultant’s study to justify a delay in decision-making. The consultant is frequently asked to be the contact person, which reduces media attention toward the organization concerned.

Socio-Economic And Political Changes

Socio-economic and political matters are always in a state of flux. For example, pollution problems cause a need for environmental protection expert, and fuel shortages / costs cause a need for energy conservation experts. For example, please refer to our ISO 14000 Environmental Management System (EMS) page.

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