In brief
Every finding from audits, accidents, near misses, periodic inspections and measurements should be gathered in a single CAPA list; each row should have a single owner, a deadline matching the risk level and closure evidence. Doing an action and the action working are not the same thing; that is why an effectiveness check is made weeks after closure. Overdue actions are managed with interim measures and a written escalation rule.
What is corrective and preventive action? Separate three concepts
In most businesses "CAPA opened" is written against every OHS finding, but what has been opened is not clear. For a corrective and preventive action (CAPA) system to work, three concepts first need to be separated:
- Correction: Fixing the finding immediately. Refitting a removed machine guard is a correction.
- Corrective action: Eliminating the cause of the finding and preventing it from recurring. Finding out why the guard was removed and moving to a design that does not need to be removed for adjustment is a corrective action.
- Preventive action: Eliminating the cause of a non-conformity that has not yet happened but could. Checking other machines with the same type of guard and making the same change is a preventive action.
The ISO 45001 standard deals with this process under the heading "incident, nonconformity and corrective action", and spreads the preventive approach across the assessment of risks and opportunities. For general information about the standard, see our article on what ISO 45001 is.
In terms of legislation, the basis is simpler. Under Art. 8/2 of Law No. 6331 on Occupational Health and Safety, the workplace physician and the OHS specialist notify the employer in writing of deficiencies and shortcomings, and of their measures and recommendations; responsibility for correcting them lies with the employer. Findings and recommendations written in the approved logbook are deemed to have been notified to the employer. In other words, the CAPA system is the record that shows the employer has fulfilled this responsibility. We described the logbook itself in our article on the approved logbook.
Where does a CAPA come from?
Findings come from different sources, and if each stays in a separate file, tracking falls apart. Combine all sources in a single list:
| Source | Example finding | How is effectiveness measured? |
|---|---|---|
| Approved logbook finding | Two-hand control buttons bridged on the press line | On-site check during subsequent visits |
| Site round or internal audit | Incompatible substances side by side in the chemical store | Observation of compliance with the store layout plan |
| Occupational accident | Forklift hit a pedestrian while reversing | Near miss and observation records |
| Near miss report | A box fell from a rack, nobody was hurt | Repeat reports in the same rack area |
| Periodic inspection report | Limit switch on the crane not working | Re-inspection report |
| Workplace measurement | Noise above 85 dB(A) in the grinding department | Re-measurement after the measures |
| Health surveillance | Decline in hearing tests on the same line | Results of the next periodic examinations |
| OHS committee decision | Painting walkways | Confirmation of closure in the committee |
Equipment marked with a "major defect" in a periodic inspection report cannot be operated until the defect is corrected; such findings go to the top of the list. We described how to collect near miss reports in our article on the near miss reporting system, and how to draw findings from a site round in our OHS site round checklist.
The CAPA form: which fields should it have?
A good CAPA form does not have to be long, but it should answer each of these questions:
Forms that leave the "cause" field blank reproduce the same finding a few months later. To get to the root cause, you can use the 5 Whys and fishbone techniques in our article on root cause analysis methods. When choosing the action, look first at elimination and engineering measures; actions that only say "instruction given" or "training given" often prove ineffective. For the levels, see our article on the hierarchy of controls.
How is the deadline set?
The deadline is set according to the size of the risk, not the owner's calendar. The legislation does not give a number of days by type of finding, so the business should have a written rule. The table below is an example internal rule built with Fine-Kinney classes; adapt it to your own policy:
| Risk class | Example internal rule | Interim measure |
|---|---|---|
| Intolerable | Work is stopped; it does not start until the risk is reduced | Mandatory |
| High | In a short time, for example within a week | Mandatory |
| Significant | Included in the action plan, for example within a month | If necessary |
| Possible | Linked to the planned maintenance or investment schedule | Not required |
We explained how scoring is done in our article on the Fine-Kinney method. The deadline for a row often depends on a purchase or maintenance job; in that case the deadline shows the completion date of the work, not of the order.
OHS action tracking: the weekly and monthly cycle
A list that is not looked at regularly turns into an archive. The rhythm of an OHS action tracking system can be set up like this:
- At every visit: The OHS specialist checks open items on site; closes those that have been done with evidence and notes those that have not.
- Weekly: Department owners update the status of their own rows. For rows one week from their deadline, the question is asked whether there is an obstacle.
- Monthly: The employer or their representative reviews overdue rows and open high-risk items, and makes resource and budget decisions.
- At the OHS committee: In workplaces with a committee, open and overdue CAPAs are a standing agenda item.
- At year end: Items not closed are carried over to the annual work plan and the annual evaluation report.
Following the tracking with numbers shows problems early: the number of open CAPAs, the percentage of overdue CAPAs, the average closure time and the percentage of actions failing the effectiveness check. We explained how to set up these indicators in our article on OHS performance indicators. You can plan visit and inspection dates with the OHS calendar.
Corrective action closure and effectiveness verification
A corrective action closure record shows that the action was done; it does not show that it worked. Define two separate steps for this reason:
- Closure: The action is complete and the evidence is on file. For example, the barrier has been fitted and its photo and installation date are on record.
- Effectiveness verification: After a while, it is checked that the same hazard has not recurred and that the risk has fallen. The verification is done not by the person who carried out the action but by the specialist or an independent manager.
The verification method is chosen according to the type of finding: on-site observation, re-measurement, record review, a short conversation with employees or re-scoring the risk. Let us follow an example:
| Step | Record |
|---|---|
| Finding | Forklift route and walkway cross at the warehouse exit; two near miss reports |
| Risk | High |
| Correction | Temporary warning sign and pedestrian waiting line at the crossing |
| Root cause | The dispatch door was not taken into account when the walkway was designed |
| Action | Fixed barrier, mirror at the pedestrian crossing, rerouting the walkway |
| Owner and deadline | Warehouse supervisor; two weeks |
| Closure evidence | Installation photos, revised layout plan |
| Effectiveness verification | Half-shift observation two months later: pedestrians do not step outside the barrier; no new near miss reports from that area |
| Result | Effective; the risk was re-scored and fell to the significant class |
If the effectiveness verification is negative, the CAPA is not closed; the cause is questioned again and a new action is written. The same finding being closed ineffectively three times shows that the problem lies not at department level but at management level. For updating the risk assessment after changes, see our article on change management and risk revision.
How are actions that are not closed managed?
Every business has overdue actions. The problem is not the delay itself but the delay remaining invisible. Put these rules in writing:
- The reason for the delay is recorded. Budget, supply lead time, the owner leaving, the action proving impractical… Each reason requires a different decision.
- Deadline extensions require approval. The owner cannot extend their own deadline; a higher manager approves the extension with a justification, and the number of extensions is limited.
- An interim measure becomes mandatory. If a high-risk item is delayed, no extension is granted without an interim measure being written.
- Escalation steps are defined. Department owner, production or plant manager, employer; how many days later each step comes into play is defined.
- If the action is wrong, it is changed. Rather than keeping an impractical action open, another action that reduces the same risk is written and the old row is closed with a justification.
- The employer's different decision is recorded. If the employer does not agree with a recommendation, they put their justification and alternative measure in writing.
In our OHS specialist service for businesses in Bursa and the surrounding provinces, we transfer the findings we write in the approved logbook to the action list on the same day, check open items on site at every visit, and enter the date of the effectiveness verification into the list.
Frequently Asked Questions
Is setting up a CAPA system a legal requirement?
The legislation does not require a form called "CAPA". However, the employer is obliged to correct the deficiencies notified in writing by the specialist and physician, and must be able to prove it. An action list or CAPA form is the most practical record showing that this obligation has been fulfilled.
What is the difference between a CAPA and the approved logbook?
The approved logbook is the official record in which the specialist and physician write their findings and recommendations. A CAPA system is the in-house system in which these findings and other findings are tracked with owner, deadline, closure and effectiveness information. The two complement each other.
Who should carry out the effectiveness verification?
Someone other than the person who carried out the action: the OHS specialist, the workplace physician or an independent manager. Having the person who did the work verify it can hide the chance of the problem recurring.
Within how many days should a CAPA be closed?
The legislation does not set a number of days by type of finding. The deadline is set according to the size of the risk; where there is danger to life, work is stopped, and for other findings the business's written internal rule applies.
A certified specialist matched to your hazard class: site inspections, approved logbook, training plan, annual plan and report follow-up.
Bursa SİSTEMER OSGB Technical Team — written from the field experience of our OHS specialists and workplace physicians. Legal information is valid as of the publication/update date; contact us for an assessment specific to your business.