Standard Operating Procedures (SOPs) are how the quality system shows up on the shop floor. A large share of inspection findings, however, stem not from "failure to follow the procedure" but from procedures written in a way that cannot be followed. These are the five mistakes we see most often:
Transferring guideline text almost word for word into an SOP answers "what should be done" but leaves "how we do it here" unanswered. An SOP should describe the company's own equipment, systems and roles.
SOPs written at a desk by the quality unit are often applied differently on the floor. Involving the people who will use the procedure at the draft stage greatly improves its practicality.
Phrases such as "appropriately", "when necessary" and "periodically" are the first things an inspector will ask about. Frequencies, limits and acceptance criteria must be measurable.
Who performs, who checks and who approves each step must be written clearly. Role definitions should be consistent with the organisation chart and the training matrix.
Change controls, deviations and CAPAs require SOPs to be updated. SOPs that are not periodically reviewed, and for which no training follows a revision, quickly drift out of line with reality on the floor.
A good SOP is short, clear, written together with the floor and reviewed regularly. If you would like to review your document system together, get in touch.
Our team is ready to plan a solution that fits your reality on the shop floor.