Information & Training. | Quality Assurance. Quality Management.

What is a Standard Operating Procedure (SOP)?

A standard operating procedure, is a documented set of instructions detailing how a task or activity is to be performed.

Why implement SOP’s, what are the benefits?

Standard Operating Procedures if documented and implemented correctly…

– Promote a consistent level of performance.

– Ensure the desired quality levels are delivered.

– Define roles and responsibilities.

– Assist in the training, learning and understanding or organizational staff.

– Allow process audits to confirm practice alignment with requirements

– Minimize the opportunity for misunderstanding and interpretation of process requirements.

– Allow process designers to state practice expectations without the need to continually revisit the process, i.e. once requirements are documented into an SOP, then the process designers can focus on other tasks.

– The SOP facilitates delegation of tasks.

Standard Operating Procedures (SOP’s).

SOP’s are documented instructions on all aspects of operations. They must be written in a format that is:

Clear

Concise

Instructional

Logical

When should an organization use Standard Operating Procedures?

As part of new employee induction training.

The SOP’s need to be part of all on-going training.

When performing tasks, for example, manufacturing a product, providing a service, staff need to be fully aware of the SOP requirements.

Where any form of testing, checking, verification activity is being performed.

Even when staff are fully competent and familiar with their on-going tasks, it is good practice to require staff to step through the relevant SOP on a periodic basic, to ensure practice is not varying from SOP requirements.

When staff are involved in job rotation, even experienced staff should review relevant SOP’s when changing from one role to the next.

Employee personal responsibility in relation to Standard Operating Procedures?

Staff need to ensure they are fully trained in the SOPs applicable within their area of work.

Employees must have a full and comprehensive understanding of the information and requirements of the SOP’s within their area of work.

Employees are responsible for ensuring they have a full understanding of the tasks to be performed.

Individuals must be confident in their ability to correctly perform required tasks.

Employees must be willing to report inconsistencies between SOPs and practice to line managers.

There must be a commitment to update the Standard Operating Procedures if requested or where you see opportunities for improvement.

Standard Operating Procedure – example template.

The format of the SOP’s vary between organizations. However, there are certain sections and types of information that are typically included in an SOP.

Title and number:

Each procedure should have a title and a unique identification number. It is also a good idea to build in a facility to deal with updated versions.

Effective date and/or revision date:

To prevent premature use and the use of outdated SOPs.

List of revisions:

A history of the changes made to the document since its first issue, with reasons for the changes.

Page number:

Each should be numbered: page x of xx

Purpose:

A statement of the purpose of the procedure

Scope:

A statement of what the SOP covers

Responsibility:

A list of the people who use the procedure

Environmental/Health & Safety:

SOPs should briefly inform operators of any hazards associated with the materials required when performing the SOP. There will be references to the relevant MSD’s (Material Safety Sheets). Environmental precautions are also mentioned here.

Procedure:

The core of the SOP details the procedure in full in a step-by-step chronological manner.

References:

Include references to all relevant other related documentation.

Standard Operating Procedure revision requirements.

It is good practice that all SOP’s should be reviewed after a set period of time. Some SOP’s will undergo frequent revision however others may not be revised for many years. In order to ensure an SOP is not overlooked or allowed to deviate from practice expectations, a time period should be established so that the SOP will be reviewed and confirmed as applicable and accurate.

For example many organizations set a review period of 2 years. If an SOP has not been revised within the prior two years, then document control should request a review of the SOP.

In order to facilitate such reviews, SOP’s are normally allocated a nominal owner. This person will lead any required reviews. He/she will identify the necessary staff inputs for effective review.

Where an SOP is revised, the 2 year (or whatever period has been established) review requirement will start from the date of revision, therefore frequently revised SOP’s may never need a review to be performed.

The review period may vary depending on the criticality of the SOP.

High criticality SOP’s will have short review periods, low criticality SOP’s will have longer review periods established

SOP reviews may also be required where changes have been enacted in regulatory requirements, or in organizational strategy, or where changes have been identified in complaint trends, process yields, etc…

SOPs should be revised after a set time period (e.g. 2 years).

After process or regulatory changes.

After changes identified in process yields, customer complaints, etc..

Standard Operating Procedure Implementation.

Once an SOP has been drafted, reviewed, approved and is ready for release, there are a number of tasks which need to be completed to ensure effective implementation.

The SOP to be released will be uniquely identified with a revision number.

There will be a defined distribution list for the new/revised SOP.

Training requirements on the SOP will be identified and a plan in place to implement.

An analysis will have been performed of SOP release impact and a list of actions identified, for example will the SOP require inventory reworking, or will there be an impact on suppliers, will customers need to provide new information, etc..

A plan will be in place to ensure all identified actions get completed.

As the new/revised SOP is distributed older revisions will be removed. Where any older revision cannot be located an investigation needs to be performed.

Document Control will maintain a history of all changes and have access to older revision documents for future reference.

Information & Training. | Quality Assurance. Quality Management.

• • • • The Principles of Quality Management

      • The Quality Manual

      • Quality Standards and Specifications  

      • The Quality Management System

      • Revised requirements of ISO 9001: 2015  

      • Design Quality – Products & Processes  

      • Good Manufacturing Practice (GMP)

      • Documentation

      • CAPA – Corrective And Preventative Action

      • Calibration Certification

      • Change Management and Control  

      • Quality Management Training

      • Product and Process Validation  

      • Supplier Quality Assurance

      • Audits & Auditing

      • Ensuring the Quality Management System is Risk based

      • Etc. …. Etc. …. Etc. …

      • Information & Training presentation   >>>