Document Pyramid – Level 2: Procedures, 1/2
“As I’ve said previously, these posts are not necessarily for the experienced Quality Professional. However, I’ve been fortunate enough to see many different methods that companies have employed for process management. Those businesses with good document management practices experience better results. Results that give reduced disruption to flow, increased quality, and gain much higher customer satisfaction rating. My desire is your growth, the improvement of your company and hope you find some value.” Carl
Recap Level 1
The previous post, Document Pyramid - L1 Policies, we examined the first tier of the pyramid. Level 1 of the Document Pyramid is the top-tier information of your company’s business and management system. Included and defined by Top Management is the why the organization exists with its policies and processes of the organization.
Pyramid Level 2
In this 3rd post in the series, we’ll dive into the second tier of the document waterfall. At this plateau the process documents and high-level SOPs (Standard Operation Procedures) are described. Documents may include Business Plans, Quality Plans, and departmental operating procedures. Each defined process in the QMS will have an associated procedure.
Level 2 of the Document Pyramid says What actions are done, Where, and When. Procedures also define Who is authorized to maintain and responsible to monitor its performance along with other pertinent information. A procedure is only created when needed to maintain process efficiency and effectiveness. Each defined process in the QMS will have an associated procedure.
A Procedure
The standard ISO9001:2015 – 7.5 Document Information and ISO/TR 10013 Guidelines for QMS Documentation provide good requirements baseline of what to document in your QMS. These standards further define processes for creating, updating, and control of these documents. The process owner is the typical owner for their procedures.
Procedures are time dependent to describe high-level and/or organizational processes. All procedures are designed to ensure the consistency of effective planning, operation, maintenance, and control of the process. Level 2 documents will reference Level 3 Work Instructions and Level 4 Objective Evidence documents as applicable. Procedures are used to describe a process, while equally important to efficiency and effectiveness is to maintain and propagate the organizational knowledge of a defined process. Keep in mind that procedures are used for training, control, problem solving, and improvement of the process.
Doc Cycle
A procedure is only good when it is applies to our objectives, provides the results desired, and provides value. The Quality Management Systems Standard ISO9001:2015 requires documented information to support the standard, as necessary for effectiveness of the QMS, is available, and suitable for use. There is more; however, suffice it to say, all documented information must be kept current. Maintain a relevant and effective process procedures by implementing this simple cycle;
Plan -- Train to it,
Do -- Use it / Refer to it,
Check -- Monitor the results and,
Act -- Schedule an annual review of results by process owner and interested parties for improvement. Update as needed.
Repeat for risk avoidance and continual improvement.
When the results are consistently good (meet or exceed defined expectations) and improving, the procedure is effective.
To improve understanding and provide clarity, procedures follow a standard flow and cover specific areas.
We’ll cover procedure content in the next blog; Document Pyramid – Level 2: Procedures, 2/2.