Responsibility and authority

The requirements on responsibility and authority are in two parts one general and the other relating to people with particular roles. Each is treated separately. 

The standard requires that the responsibility, authority, and interrelation of personnel who manage, perform, and verify work affecting quality be defined and documented. 

The key to this requirement is determining what work affects quality i.e. if you can identify any work that does not affect quality, you are not obliged to define in your quality system the responsibilities and authority of those who manage, perform, or verify it. 

Apart from result-producing activities, there are several other activities that could affect quality  

If there are personnel involved with the identification, interpretation, promulgation, and verification of such regulations then their responsibilities and authority will need to be defined in the quality system. 

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Assign responsibilities and authority at plant and headquarters for tbe storage, coUection, treatment, and disposal of all types of hazardous wastes. 

Defining the responsibility and authority of personnel can be achieved in several ways but first let s look at what we mean by responsibility and authority. 

A person s job can be divided into two components actions and decisions. Responsibilities and authority should therefore be described in terms of the actions assigned to an individual to perform and discretion delegated to an individual that is, the decisions they are permitted to take along with the freedom they are permitted to exercise. Each job should therefore have core responsibilities, which provide a degree of predictability, and innovative responsibilities, which in turn provide the individual with scope for development. 

In defining responsibilities and authority there are some simple rules that you should follow ... 

ISO 9001 requires responsibilities and authority to be documented in addition to being defined, as one can define such things in dialog with one s staff without documenting them. This is indeed a common way for staff to discover their responsibilities. Sometimes you may not be aware of the limits of your authority until you overstep the mark. By documenting the responsibility and authority of staff, managers should be able to avoid such surprises. 

There are four principal ways in which responsibilities and authority can be documented ... 

The standard does not stipulate which method should be used. In very small companies a lack of such documents defining responsibility and authority may not prove detrimental to quality provided people are made aware of their responsibilities and adequately trained. However, if you are going to rely on training, there has to be some written material which is used so that training is carried out to consistent standards. 

Terms of reference are not job descriptions but descriptions of the boundary conditions. They act as statements that can be referred to in deciding the direction in which one should be going and the constraints on how to get there. They are more like rules than a job description and more suited to a committee than an individual. They rarely cover responsibilities and authority except by default. 

Within ISO/TS 16949 there are several requirements for an assignment of responsibility. These include the responsibility and authority for ... 

Defining individual responsibilities and authority alone will not define how personnel relate to one another. Interrelation means to place in mutual relationship, so what is needed is a definition of the relationships between all staff with quality responsibilities. The primary reason for defining interrelationships is to establish channels of communication so that work proceeds smoothly without unplanned interruption. Staff need to know from whom they will receive their instructions, to whom they are accountable, to whom they should go to seek information to resolve difficulties, and to whom information or product should be submitted when complete. 

An organization may respond to these requirements in several ways, so in managing the quality system a list of the documents is needed which contains the definition of people s responsibilities and authority. The difficulty arises in keeping all such documents compatible and so it is often better to limit the documents to the three types above, if possible. 

The standard requires management with responsibility and authority for corrective action to be promptly informed of products or processes which become noncompliant with specified requirements. 

Appoint a management representative to manage the quality system and define, agree, and publish the responsibilities and authority. 

Whom have you appointed as your customer representatives and what responsibility and authority have you given them ... 

Do ensure there is no conflict between the responsibilities and authority of different managers. 

On responsibility and authority The responsibility and authority of all personnel shall be defined and documented within the procedures that apply to the operations they perform. In addition, the responsibilities, authority, and accountabilities for those holding specific positions or carrying out a particular trade or profession shall be defined in Job Profiles. ... 

Keep the description of the organization (including the associated responsibilities and authority) compatible with the actual staff relationships and their responsibilities and authority. 

Provide a procedure that defines the activities, responsibilities, and authority of all staff involved in the process. 

Although records are mentioned in clause 4.1.2.1 this clause deals with responsibilities and authority and contains no requirements to generate any records. 

The guidance for tliis element covers responsibilities and authorities, determination of the significance of a quality (ESH/PSM) related problem, root cause investigation, cause-and-effect analysis, preventive actions and additional controls, and change documentation. For ESH/PSM, this element might be interpreted as covering both potential hazards as well as actual problems. 

Clearly define cyber security roles, responsibilities, and authorities for managers, system administrators, and users. 

Organization and personnel describe that in the dispensing of all prescriptions, the pharmacist has the responsibility and authority to inspect and approve or reject all components, drug product containers, closures, in-process materials, and labeling. It also has the authority to prepare and review all compounding records to assure that no errors have occurred in the compounding process. The pharmacist is also responsible for fhe proper maintenance, cleanliness, and use of all equipmenf used in prescription compmmding practice. 

FDA has responsibility and authority over all parties participating in FDA-regulated research and has regulations unique to product review responsibilities. 

In 1950, the Council gave the Secretary of the Army the responsibility and authority for any program conducted or sponsored by the Army. The Secretary was to ensure adherence to both the Organization of the Army Act and the Nuremberg code. There was no evidence that he delegated this authority to a lower level. 

Subpart B, Organization and Personnel. It diseusses the responsibilities and authority of the eompounding pharmaeist and other individuals involved in the eom-pounding proeess. 

The organization s incident investigation management system should specify the team leader s responsibilities and authority. Upon selection of the team leader, the leader and senior management should review and agree on all assigned responsibilities. The agreed responsibilities should... 

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