Recording deviations and non-conformances: what belongs in a deviation report?

Deviation, non-conformance and complaint: which is which?

In practice the words get mixed up. A deviation is any situation in which the work goes differently than the procedure, the recipe or the specification prescribes. Strictly speaking, a non-conformance is a deviation from a defined requirement: the product, process or system does not meet what was agreed. Many companies use both words for the same thing, and that is fine as long as everyone uses the same report.

A complaint comes from outside: a customer reports a problem with what you delivered. A complaint often leads to a deviation, but you find most deviations yourself, on the floor, in the warehouse or in the lab. A few examples:

• A fill weight outside the limit at the eleven o'clock check
• A material with a different lot number than the one on the pick list
• A check that was skipped or carried out late
• A mixer that ran at the wrong temperature during the batch
• Damaged packaging or an unreadable label at goods receipt

Why you record every deviation

A deviation that is only solved verbally is forgotten after the shift. If the same problem comes back a month later, nobody remembers what was done then or why.

Recording serves three purposes. The product stays under control: nonconforming product is kept apart and not shipped by accident. The batch record is complete, so quality sees what happened at release. And the cause can be found and removed, so it does not happen again.

Quality standards ask for this too. ISO 9001 asks in clause 8.7 for control of nonconforming outputs and in clause 10.2 for recording nonconformities and corrective actions. GMP guidelines and food safety standards set similar requirements.

What must a deviation report contain at a minimum?

A deviation report, also called an NCR (non-conformance report), does not have to be long. It does have to answer these questions:

• What happened, in one or two sentences, with the measured value and the limit
• Where and when: line, machine, date and time
• Which product, order and batch or lots are affected, and how much
• Who found and reported it
• What was done with the product straight away: blocked, reworked, rejected or released with approval
• The cause, as soon as it is known
• The action to prevent recurrence, with an owner and a deadline
• Who closed the report, and when

How to record a deviation, step by step

A way of working that keeps working on the floor is short for the person reporting and complete for quality. A photo often says more than a description: a crooked label, a leaking cap or a dirty sieve. The steps:

• Report: the operator records straight away what is wrong, with a photo, against the batch being worked on
• Contain: the affected product is blocked or set aside until there is a decision
• Assess: quality decides how serious it is and what happens to the product
• Investigate: someone looks for the cause, for example with the five whys method, and records an action
• Close: once the action is done, someone checks that it works and closes the report

An example: fill weight too low on line 2

At 11:10 the operator on line 2 measures a fill weight of 246 grams in batch 88213, while the limit is 250 to 256 grams. The operator records the deviation with the measured values and a photo of the scale, and sets aside the cases from the last half hour.

At 11:40 quality assesses the deviation. The cases set aside are reweighed: the underweight bottles are rejected, the rest is released. The investigation points to a worn dosing valve. Maintenance replaces the valve, and the recorded action is to check the valve at every service from now on.

After ten batches without an underweight fill, the report is closed. When batch 88213 is released, quality sees in the batch record exactly what happened and what was done about it.

Where paper and Excel break down

Many companies have a paper deviation form or a list in Excel. That works as long as there are few deviations and one person keeps track of everything. After that, the same things keep getting stuck:

• The form is only filled in at the end of the shift, when details are already forgotten
• The deviation is separate from the batch and has to be found again at release
• Actions have no owner or deadline and stay open
• Nobody sees which deviations recur, because causes are written as free text
• Photos stay on a phone and never reach the report

Where Frontlink fits

In Frontlink you record a deviation from what happens on the floor: a check outside its limit, a stop or a report from an operator. The deviation carries the batch, order, machine and time, with photo, cause and action, and an owner and deadline. It stays visible until it is resolved, and at release quality sees in the batch record whether any deviations are still open.

A Frontlink engineer builds it at your site, on your own data and ERP. You start with one process, which is usually running within a few weeks.