Roles verses Titles in the Laboratory

abstract

Job descriptions are an integral part of an ISO/IEC 17025 quality system. People are given titles when they go to work in a laboratory and no matter how hard one tries, the titles provided for human resources don't always align with the needed roles in a laboratory. Wearing Many HatsTo complicate matters even further, the responsibilities defined by employee titles and roles are seldom aligned (and often contradictory) with the responsibilities and authorities required by the quality system. This is often referred to as "wearing many hats", but is actually a problem that most laboratories need to solve. The best approach to arrive at the solution is to review what roles and titles are, the implementation of quality system records versus human resources (HR) records, and how to best translate the requirements of ISO/IEC 17025 into responsibilities, authorities, and skills in the job descriptions of a quality system.

Quality versus HR Records

To distinguish between the titles employees have earned through employment and the roles contained in the various functions in the laboratory, it is best to first discuss the difference between quality system records and human resources (HR) records. The documentation in the quality system is for the specific purpose of implementing a quality system that is compliant to the quality standard; while human resources (HR) records are exclusively used for private employee information such as salary and benefits information, disciplinary actions, employee agreements, etc. It should also be noted that human resources (HR) records are governed by federal, state, and local laws that mandate, amongst other things, privacy of employee records.

It is common for employee records to contain resumes and training records, but, the quality system should maintain separate records for training that are relevant to the scope of the laboratory and leave the corporate systems training (not relevant to the laboratory) in the HR file. Employees should also understand that any records in the quality system will be viewed by an auditor that may be an accreditor or possibly a customer. They should also understand that anything in their personnel files will be off limits to the auditor, understanding that some of the records may be common to both but there will be separate copies.

By making sure that there are two, distinct files for employees, HR and quality system, the requirements of the quality system can be achieved without violating any laws governing human resources. This separation should be a planned, conscience, act within the laboratory to ensure compliance with the law first, and the quality system second.

Titles and Roles

Dictionary.com gives us the following definitions:

title: a descriptive or distinctive appellation, especially one belonging to a person by right of rank, office, attainment, etc.

role: proper or customary function. [synonym: responsibility]

A title is essentially a designation of an employee as to how they fit into the corporate structure that surrounds their position while a role describes a function or responsibility performed by an individual given that role. In a quality system, the job descriptions become a list of the responsibilities, authorities, and necessary skills needed to operate the laboratory. For a quality system, it is best to distinguish between these words and use only one to describe the job descriptions, hence, Roles better describe the lists of responsibilities resulting from ISO/IEC 17025.

Each job description is usually broken down into a general competency area such as technical, quality, managerial, administrative, etc. and within each of the descriptions will be lists of specific responsibilities and authorities required for that role, but where do these lists appear in the quality standard? Unfortunately, there are no lists, but, there are some key words that point to these responsibilities and authorities. The word "shall" is certainly key and when used within the phrase "shall ensure that", provides an excellent indication that a designated role, or roles, needs to be responsible for something because somebody needs to make sure it gets done.

For example, clause 4.1.6 of ISO/IEC 17025 says "Top management shall ensure that appropriate communication processes are established within the laboratory and that communication takes place regarding the effectiveness of the management system". The laboratory's quality manual may address this in more than one way such as "the laboratory communicates using email" or "Memos will be issued by top management to all staff". This may satisfy some auditors and satisfy the requirement but what happens when a memo can't be found (in quality language, meaning it never happened)? A role based approach would place the essence of this clause and list it as a responsibility under one (or more) of the job descriptions. Now, there are people answerable to the issue of communications throughout the laboratory. Although a lost memo may relate more to document control or record retention, the fact that information about the effectiveness of the management system did not make it to the staff, could indeed be cited here. A simple corrective action could be training for those individuals with this responsibility in their job description.

Responsibilities from ISO/IEC 17025

Many of the responsibilities prescribed by ISO/IEC 17025 would be common to all laboratories, albeit some may have significantly more importance to some than to others. Additionally, laboratories will have particular responsibilities focused on the core competency of services offered. The table below lists the requirements related to the "shall ensure that" clauses so prevalent in the standard.

Responsibilities
Clause Responsibility
4.1.2 Ensure that the requirements of ISO 17025, customer needs, regulatory authorities, and accreditors are met.
4.1.5(a) Implements and maintains the quality system and identifies departures from the quality or technical requirements and initiates actions to minimize any departures.
4.1.5(g) Provide adequate supervision of testing (calibration) staff, including trainees.
4.1.5(h) Overall responsibility for all technical operations.
4.1.5(h) Ensure that the management system related to quality is implemented and followed at all times.
4.1.5(k) Ensure that staff are aware of the relevance and importance of their activities in achieving the management system objectives.
4.1.6 Ensure that the effectiveness of the management system are appropriately communicated within the laboratory.
4.1.6 Ensure that the effectiveness of the management system are appropriately communicated within the laboratory.
4.2.3 Committed to implementing the quality system and this website.
4.2.4 Requires that all staff members understand the importance of meeting customer, statutory, and regulatory requirements.
4.2.6 Ensure compliance with ISO 17025.
4.2.7 Ensure that the integrity of the quality system is maintained during any changes that have been planned and implemented.
4.4.1 Ensure that the customer's requirements, including test(calibration) methods, are adequately defined, documented, and understood.
4.4.1 Coordinate with the Technical Manager and Test (Calibration) Engineer to ensure the laboratory has the capability to fulfill the customer's request and that the appropriate test (calibration) method is selected and capable of meeting the requirements.
4.4.1 Resolve any differences between the request or tender and the contract until both parties are satisfied.
4.6.3 Review purchasing documents and inspection records for purchased items that may have an affect on the quality of tests.
4.7.2 Analyze customer feedback to improve the management system, testing (calibration) services, and customer satisfaction.
4.7.2 Solicit both positive and negative feedback from customers and forward to the Quality Manager to analyze for process improvements and customer satisfaction.
4.9.1 Report any anomalies regarding testing (calibration) work to the Quality Manager.
4.9.1 Coordinate any aspect of non-conforming work with the Technical Manager.
4.9.1 Manage non-conforming work, including authorizing the resumption of work. Report any anomolies regarding testing (calibration) work to the Quality Manager.
4.14.1 Plan and organize internal audits according to the schedule and management requests.
5.2.1 Responsible for the technical competence of the laboratory staff.
5.2.3 Responsible for all lab staff, whether employed by the laboratory or contractors to the laboratory, and that they are acting in accordance with the quality system.
5.2.5 Authorizes staff to perform particular tests, calibrations, or sampling. Also provides authorization for reviewing and approving reports.
5.3.1 Ensure that the temperature, humidity, and barometric pressure are within the reuirements of the test (calibration) specifications.
5.4.3 Plan the implementation and assign adequate and appropriate resources to complete any laboratory-developed methods.
5.4.5 Validate non-standard methods or standard methods used outside their original scope.
5.4.7 Sufficiently document any laboratory-developed software and the validation of its use.
5.5.3 Authorized to operate the equipment and/or to designate who may operate the equipment.

In addition to the responsibilities inferred in ISO/IEC 17025, there are various authorities and skills that are mandated as well. These are very important to the laboratory because defining which role in the laboratory has the authority to perform certain tasks, related to the quality system, is crucial to a successful implementation of a quality system.

Authorities
Clause Authority
4.1.5(h) Implement the management system related to quality and make sure it's followed at all times.
4.1.5(h) Provide the skilled test (calibration) resources.
4.1.5(h) Ensure quality of the laboratory operations.
4.2.2 Top Management issues quality policy statement.
4.3.2 Approve quality documents as required.
4.4 To process requests and offer tenders.
4.6.3 Based on the inspection records for purchased items that may have an affect on the quality of tests, accept or reject items for use within the laboratory.
4.9.1 Control non-conforming work including halting work, withholding of test reports (calibration certificates), determining the acceptability of non-conforming work, and authorizing the resumption of work.
4.9.1 Halting non-conforming work.
4.11.1 Implement Corrective Actions.
Skills
Clause Skills
4.1.5(g) Be familiar with the methods and procedures of the laboratory.
4.1.5(g) Understand the purpose of each test (calibration).
4.1.5(g) Can assess test (calibration) results.

Conclusion

By applying roles to members of the laboratory, that have different titles, it is possible to separate the quality designated functions of an individual from the human resources titles. This allows the quasi-public records contained in the quality system to be segregated from the human resources records that are governed by various laws and other legal requirements and that must be kept private. The use of roles also allows employees to grow within the corporation by receiving promotions and changes in title while maintaining their respective roles in the laboratory. Although the authorities, responsibilities, and skills listed may not be exhaustive, these lay an excellent foundation for developing the job descriptions and then relating them to specific clauses in the quality manual. There are also other responsibilities and authorities mandated by an accreditor that would need to be added, and the same principles would apply.