Qualified Person competences

To comply with OSHA competent/qualified person requirements, each project will have a project competent person capable of identifying existing and predictable hazards and having authority to take prompt corrective measures to eliminate them. This individual may designate other competent persons to perform certain tasks, such as supervising scaffold erection. 

Competent/qualified persons will be designated for each project and listed on the company s Safety and Health Competent Person Assignments Form. This form will be completed and displayed at all operations requiring the presence of a competent/qualified person. The form should be updated and replaced as necessary to reflect current designated competent/qualified persons and their area of expertise and responsibility. 

This plan must identify (as a specific individual) all competent or qualified persons required by applicable regulations or host organization procedures. 

This guideline lays down the roles and responsibilities of the MAH and of the national competent authorities in respect of the products authorised through the national procedures (including the mutual recognition procedure). Also defined are the roles and responsibilities of the Reference Member States (for mutual recognition products) and of the rapporteur and EMEA for centrally approved products. The role and responsibilities of the MAH include having a named, qualified person responsible for pharmacovigilance at the EU level, and there may be a need for an additional named person at the national level when this is required. 

Medical research involving human subjects should be conducted only by scientifically qualified persons and under the supervision of a clinically competent medical person. The responsibility for the human subject must always rest with a medically qualified person and never rest on the subject of the research, even though the subject has given consent. 

In all cases, the qualified person must certify in a register or equivalent document that each production batch satisfies the provisions of this Article. The said register or equivalent document shall be kept up to date as operations are carried out and shall remain at the disposal of the agents of the competent authority for the period specified in the provisions of the Member States concerned. This period shall in any event be not less than five years. 

In order to establish and maintain a pharmacovigilance system, the holder of the marketing authorization is required to have permanently and continuously at his or her disposal an appropriately qualified person. This qualified person is personally responsible for ensuring that information about all adverse reactions that are reported to the personnel of the company and to medical representatives is collected and collated. This qualified person is also responsible for ensuring that all suspected serious adverse reactions are reported to the competent authority concerned. 

As for manufacturing of other pharmaceuticals, a system should be established to verify the quality of the starting materials used in manufacturing radiopharmaceuticals. This system must assure that no material is used for production until it has been released by a competent person [qualified person (QP) or others given this responsibility]. 

Most of the information sought is similar to FDA s IND requirements. One major difference is that a Qualified Person has to certify that the investigational medicinal product (IMP) is manufactured according to GMP. The Competent Authority has the right to inspect the manufacturing facility for GMP compliance, the preclinical facility for GLP compliance, and the clinical trial sites for GCP compliance. 

In summary, PGDs are most suitable when the use of medicines follows a predictable pattern and is not tailored for individuals with complicated conditions. They are generally most appropriate to manage a single treatment episode or series of episodes of the same condition. Nevertheless, an appropriate person should be identified within any healthcare organization to ensure that only fully competent, qualified and trained health care professionals are allowed to use PGDs. 

The notion of competency as a requirement in CRM is well established in other industries such as nuclear power. In engineering the term SQEP (pronounced squep ) is used to refer to those who are Suitably Qualified and Experienced Personnel. SQEP implies that an individual is a professionally qualified person who has several years as a practitioner, is registered in their area of expertise within the organisation and so whose judgement can be used to resolve a technical problem with some finality [1]. In many cases formally establishing SQEP in these industries is a fundamental pre-requisite to employment or allocation to a project. 

Competent persons and qualified persons Employers must train each competent person and each qualified person on the requirements applicable to their respective roles. 

The work has to be directed by an A/D (Assembly/Disassembly) director. The A/D director must meet the criteria for both a competent person and a qualified person, or must be a competent person assisted by a quahfied person. The A/D director must ... 

OSHA requires that the various inspections be conducted by either a competent person or a qualified person depending on the type of inspection. Competent person means one who is capable of identifying existing and predictable hazards in the surroundings or working conditions which are unsanitary, hazardous, or dangerous to employees, and who has authorization to take prompt corrective measures to eliminate them. 

Competent person or qualified person and how they fit in the inspection process. 

Training for competent and qualified persons is required rmder 1926.1430(d). 

OSHA says a qualified person, not a competent person, is more appropriate to train employees. This gives you the opportunity to use outside sources, such as scaffold manufacturers or suppliers, that regularly provide these types of services to clients. 

Pharmacist Technician Qualified person Competences Awareness Responsibilities Training Decisions... 

The competent person need not necessarily be from an independent authority, but can be an internal appointment of a suitably qualified person by the company concerned, but in exercising his responsibilities for carrying out examinations he must be separated from any other functions that might cause a clash of interests. The competent person, whether employee or from a specialist organisation, must be allowed to act objectively and in a professional manner. 

It is the responsibility of (name of competent person) to implement this Fall Protection Plan. (Name of Ctompetent Person) is responsible for continual observational safety checks of their work operations and to enforce the safety policy and procedures. The foreman also is responsible to correct any unsafe acts or conditions immediately. It is the responsibility of the employee to understand and adhere to the procedures of this plan and to follow the instructions of the foreman. It is also the responsibility of the employee to bring to management s attention any unsafe or hazardous conditions or acts that may cause injury to either themselves or any other employees. Any changes to this Fall Protection Plan must be approved by (name of Qualified Person). 

Any changes to the plan will be approved by (name of the qualified person). This plan shall be reviewed by a qualified person as the job progresses to determine if additional practices, procedures or training needs to be implemented by the competent person to improve or provide additional fall protection. Workers shall be notified and trained, if necessary, in the new procedures. A copy of this plan and all approved changes shall be maintained at the jobsite. 

B. Since many of the duties relating to employee protection are dependent on the results of monitoring and measuring procedures, employers should assure that the evaluation of employee exposures is performed by a competent industrial hygienist or other technically qualified person. 

---