Procedures vs. Work Instructions

Procedures vs. Work Instructions

I was recently working with a process owner to modify one of his procedures.
And part of the conversation was that, in my opinion, his procedure looked more like a work instruction.
He felt that those details were necessary to perform the job and my answer was that those could be written in a work instruction for the specific task.
What has been your experience in this situation?

Many spears were broken when arguing on this comprehensive issue. Here below we express only an opinion.

1. It is not a good idea to argue about terminology, but worth agreeing upon it. This fully applies to the names of the QMS documented information. Each organization sets its own documented information ‘pyramid’. The requirements of ISO 9001:2015, as well as the 2008 guidelines of ISO 10017 and the recommendations 176 TC reports give full freedom to the organization. Therefore, it is better not to talk about the requirements, but better about good practices and experience.

2. Definition and etymology of the word.

Procedure - specified way to carry out an activity or a process. (In ISO 8402:1994:  Procedure - specified way to perform an activity)

The term ‘procedure’ is of Latin origin and means ‘advance’, ‘go step by step’.

3. In the current practice of QMS development, implementation, and certification in compliance with ISO 9001:2015, a procedure:

•        is used to describe the QMS processes as per clause 4.4 ISO 9001:2015;

•        answers the questions: ‘Who does?’ (Responsibility and authority of the process owner and operators), "What to do?" "In what order?", "When to do?" (Frequency), "Where to do?" (possible link to subdivisions as per Provisions of subdivisions);

•        describes the interaction of a process with other QMS processes (a good practice is to use a process models in accordance with sec 0.3 ISO 9001:2015 TC 176 reports recommendations);

•        contains steps for working with processes criteria;

•        contains actions to address risks and opportunities in the process (or references to those actions).

Basically, a procedure may include a description of the technological rules (method) to conduct an activity – contain the answer to the question ‘How to do?’ There are no regulatory contraindications with respect to such decisions.

But as per the established practice, the rules to conduct an activity (the answer to the question "How to do?"), if necessary, are set in the work instructions or methodologies.

4. Practical Recommendations

Do not try to establish an ‘iron curtain’ between the procedures and work instructions.

When developing procedures, as well as other documented information, it is important to maintain a balance between a procedure being self-sufficiency (the user must be able to work with the procedure without having to search for a variety of other normative documentation via references) on one hand, and not being overloaded (excessive detail obscures understanding the essence) on the other.

These scales are always swinging, particularly at the stages of development and implementation. At some point, we have to add something, at another we are forced to cut. And that’s Ok. If the documented information ‘breathes’, it means that the QMS is ‘alive’, and not just exists somewhere in a heap of trash documents (according to our subjective assessments, such a possibility is «fifty-fifty»).

A few common recommendations.

1) Formalize a part of the procedure into a separate regulatory document (for example, operating instructions or techniques, or ...) with the corresponding reference:

• If more details are required;

• if this part is modified more frequently than others - to simplify modification.

2) Actively use validation of documented information before its approval. This recommendation of ISO 10013 is very valuable. Psychologically users scribble ‘drafts’ easily and naturally.

  

More on Control of Documented information

ISO 9001:2015 Quality System Procedure - Control of Documented Information

• Describes Criteria and Risks of ‘Control of Documented Information’ Process 
• Contains Process Model diagram with detailed inputs and output 
• User-friendly format and professional layout - reviewed and approved by experienced ISO 9001 quality auditors.

Control of Documented Information in ISO 9001:2015 Clauses

• Lists Documented Information requirements referencing the clauses of ISO 9001:2015 
• Provides recommendations for Documented information maintenance for each clause. 

ISO 9001:2015 Documents and Templates collection