7 replies to this topic

[DEAREST]

Hi all,

 

Please give ideas on how to conduct  a root cause analysis for the following NCs raised during an FSSC audit.

 1. Refiner operators were observed to be wearing overalls with buttons and pockets above the waist.

 2. 1 out of 14 members screened had not been medically examined.

 3. It was not demonstrable that the procedure for withdrawal had been tested to ensure effectiveness of the management system.

[Charles.C]

Hi all,

 

Please give ideas on how to conduct  a root cause analysis for the following NCs raised during an FSSC audit.

By reference to FS system standard hygiene requirements (1,2) / FS system standard operational requirements(3)

 

 1. Refiner operators were observed to be wearing overalls with buttons and pockets above the waist.

Lack of understanding of  hygienic requirements, ie undesirability of contamination hazard due foreign objects in the production area

(or possibly lack of implementation of  hygiene requirements depending on the situation)(or possibly both)

 

 2. 1 out of 14 members screened had not been medically examined.

Same as 1, with "foreign objects" replaced by "workers with unacceptable health condition".

 

 3. It was not demonstrable that the procedure for withdrawal had been tested to ensure effectiveness of the management system.

Lack of understanding of  validation/ verification procedural requirements, ie need for supporting data. (or possibly lack of implementation, again)

 

 

Rgds / Charles.C

 

PS - Personally, I would have intuitively put 2 as more significant than 1 but I daresay yr auditor did not prioritize. Or maybe you are a supplier to NASA.

[Zeeshan]

Two of the simple tools to do root cause analysis are 4M (Man, Machine, Material, Method) based fish bone diagram and 5-Why. But how to start analysis is the most interesting aspect. Following are some steps which you may take.

 

1- Call a meeting of your HACCP or Food safety team. The members must include authoritative persons from Production, HR/Administration, Sales and QA.

 

2- Present to them in the meeting all the findings one-by-one and ask (brainstorm) or investigate (5-Why) about the possible causes.

 

3- With mutual consent, select the root cause or root causes of each problem and discuss its countermeasure.

 

4- Get approval of the countermeasure before implementation if necessary.

 

5- Validate the countermeasure. If results are OK then your analysis is proved as correct.

[Charles.C]

Dear Dearest,

 

Here is the encyclopedical response -

 

http://en.wikipedia...._cause_analysis

 

i prefer simple logic as far as possible. But yr auditor may approve some increased dispersion of the blame.

 

Rgds / Charles.C

[DEAREST]

Thanks a lot for your input. I'll now be able to close the NCs raised.

[DEAREST]

Rgds / Charles.C

 

PS - Personally, I would have intuitively put 2 as more significant than 1 but I daresay yr auditor did not prioritize. Or maybe you are a supplier to NASA.

The member who was not screened is the Manager and is rarely in the factory.

[Mujeeb Mustafa]

Don't forget to follow your written Corrective & Preventive Action Procedure while performing Root Cause Analysis.

[Philips]

This forum is so interesting, we learn alot form it..., Root cause analysis; this is how  I train. Any given nonconformity has three main response segments; i) Root cause, ii) correction and iii) corrective actions

Once a nonconformity is raised, 1st establish the root cause, what is the most probable reason that made this to happen, e.g. 1 out of 14 sampled didn't have a medical exam report - Lack of a proper system in monitoring the processes in meeting the intended results

Correction; Immediately have the 1 person be medically examined and attach the results to NC for objective evidence

Corrective action - Always the corrective action should address the root cause - Since there was no proper system in monitoring the processes in meeting intended results, establish one, i.e. You can say, you will on monthly basis audit the medical exams records for employees since the expiry period may not be the same, OR you apply Microsoft outlook to provide alerts whenever a given individual period lapses, its one of the most effective method since its scheduled and alert one automatically you switch on the computer, guess this is good enough