Spreadsheet: 137369d1327079372-how-to-filter-this-data-correctly-ef13_audit-template
Sheet: 189 ATM Module Repair

Company Name: | Testlink |  |  |  |  |  | Site: |  | Poole
Audit reference: | 189 |  |  |  |  |  | Date: |  | 2011-09-12 00:00:00
Assessment of: | Test and Repair - ATM |  |  |  |  |  | Auditee(s): |  | [NAME], Technicians, Engineers
Distribution: | Name |  |  |  |  |  | Name
 | [NAME]
 | [NAME]
 | [NAME]
 | [NAME]
Click here to return to audit programme |  |  |  |  | Audit Programme
Objective
To audit in accordance with the requirements of BS EN ISO 9001, BS EN ISO 14001, IMS Manual and Procedures.  To report the results of the audit and to ensure that the follow-up activities are carried out promptly to eliminate non-conformances and their causes.  To identify and report on improvement activities and progress against performance monitors.
Audit trails and sources of evidence
Description |  |  | [NAME] sources (eg document reference numbers or titles)
IMS Policy Manual & Procedures |  |  | 1.01, 1.05, 3.04, 3.05, 3.07, 3.09, 3.10, 4.02
Environmental |  |  | Policy dated
Waste |  |  | Waste [NAME] company desktop
Process, function or area assessed: |  |  | Resource Planning and Review
Evaluations and Conclusions |  |  |  |  |  |  |  |  |  | Outcome |  | Deficiency Ref |  | Owner
Arek has taken over the position of area supervisor.  Arek went through procedure 3.09 and amended some points.  Update procedure 3.09 |  |  |  |  |  |  |  |  |  | Observation |  |  |  | AD
Arek went through the planning process as per Procedure 3.09, section 3.  The weekly ops meeting has now become a daily ops meeting (last held 12/09/2011).  Communication between all functions within Operations has greatly increased (as demonstrated in OTD) and are now much more team orientated. |  |  |  |  |  |  |  |  |  | Compliant
Arek confirmed the use of Work Flow on Filemaker is constantly being checked for planning and reviewing the status of jobs – no issues raised.  No changes since last audit. |  |  |  |  |  |  |  |  |  | Compliant
Process, function or area assessed: |  |  | Allocation of Work
Evaluations and Conclusions |  |  |  |  |  |  |  |  |  | Outcome |  | Deficiency Ref |  | Owner
Arek was able to demonstrate how work is allocated by looking at work flow.  No issues raised |  |  |  |  |  |  |  |  |  | Compliant
During the last audit cell leaders were scheduled to be assigned stamps by Martin to use whilst testing, however Arek decided that it was not necessary and could not be satisfied that the stamps would not be used by other operators. |  |  |  |  |  |  |  |  |  | Compliant
Process, function or area assessed: |  |  | Assessment of product
Evaluations and Conclusions |  |  |  |  |  |  |  |  |  | Outcome |  | Deficiency Ref |  | Owner
No issues raised with the assessment of presenters. [NAME] ran through the process (sampled 998189 which had just been assessed and the description of faults were clear on filemaker). |  |  |  |  |  |  |  |  |  | Compliant
ESD strap testing and strap usage could not be demonstrated by everyone. Mixture of operators signing and not signing to confirm their straps had been tested.  During discussions with Arek it became evident that the testing was not being enforced.  [NAME] training has also not been provided for some time. Action: Look at the root cause, and decide if refresher training is required to reinforce the importance of ESD protection for the product. |  |  |  |  |  |  |  |  |  | Deficiency |  | 189/1 |  | PB
Work benches checked equipment and ESD calibration – Bench 15 – out of calibration check Bench 13 – out of calibration check Solder iron 2141 (Bench 13) Calibration due 26/05/2011 Action: Action Review current maintenance/ calibration prompting and actioning |  |  |  |  |  |  |  |  |  | Deficiency |  | 189/2 |  | PB
Reviewed cleaning activities – the new extraction fan has been installed and working.  Investigate a master power down switch for the room to switch off the ultrasonic tank, fan and steam cleaner to reduce the potential for equipment being left on. |  |  |  |  |  |  |  |  |  | Compliant
Noise has been identified as an issue in the cleaning room, and also for operators within the immediate area.  Arek is organising ear defenders and is looking at putting a plastic curtain on the doorway to minimise noise outside the room.  Check during next audit. |  |  |  |  |  |  |  |  |  | Observation |  |  |  | AD
Ph and temperature readings were taking place (closure of CHR 183/1), however this has stopped again.  [NAME] confirmed that the ultrasonic tank is drained down around 3 times per week, but no records are completed.  Currently we are unable to confirm we are complying with the discharge consent from Wessex Water.      CHR 189/3  Action:  Reintroduce monitoring and train operators on the importance of monitoring. |  |  |  |  |  |  |  |  |  | Deficiency |  | 189/3 |  | PB
Waste bins around the workshop were clearly marked and no evidence of cross contamination was noted.  A question mark was raised over putting the belts in with the WEEE, but after discussions with [NAME] and the fact that W&S recycling have never told us we shouldn’t be putting belts in with the WEEE (they are part of the machines) a decision was made to continue putting the belts in with the WEEE for recycling. |  |  |  |  |  |  |  |  |  | Compliant
Walkways are unblocked, but work benches are quite messy.  The layout of the benches is under review and newer benches are being brought over from the Prague facility when it closes later in the month.  Check during next audit. |  |  |  |  |  |  |  |  |  | Observation |  |  |  | AD
Process, function or area assessed: |  |  | Spares and Reclaim
Evaluations and Conclusions |  |  |  |  |  |  |  |  |  | Outcome |  | Deficiency Ref |  | Owner
Reclaim system taking place, Arek confirmed that stores ensure spares boxes are refilled at least once a day now.  Boxes were clearly identified on the “Reclaim parts for cleaning” area |  |  |  |  |  |  |  |  |  | Compliant
The new cleaner has just started and the aim is for the cleaner to clean the reclaimed parts.  Check during next audit. |  |  |  |  |  |  |  |  |  | Observation |  |  |  | AD
Process, function or area assessed: |  |  | Warranty
Evaluations and Conclusions |  |  |  |  |  |  |  |  |  | Outcome |  | Deficiency Ref |  | Owner
Sampled current warranty claim, job 998945 (Tested 30/08/2011 by TL89).  No information about the fault on the inbound paperwork.  Arek carried out visual check and nothing looked out of the ordinary, so carried out a functional check, and the reader would not take the card.  Further investigation required. |  |  |  |  |  |  |  |  |  | Compliant
Process, function or area assessed: |  |  | BER
Evaluations and Conclusions |  |  |  |  |  |  |  |  |  | Outcome |  | Deficiency Ref |  | Owner
No BERs were available during the audit to follow an audit trail |  |  |  |  |  |  |  |  |  | Compliant
Added to procedure 3.09, Section 8.9 that the secure room is another route for disposal, and remove 8.10 |  |  |  |  |  |  |  |  |  | Compliant
Process, function or area assessed: |  |  | Repair
Evaluations and Conclusions |  |  |  |  |  |  |  |  |  | Outcome |  | Deficiency Ref |  | Owner
Repair process was reviewed post inspection process – no issues raised against recording of work carried out.  It was noted that the engineer was not using glasses whilst using chemical sprays (resolved during the audit), but Arek to reinforce importance of using glasses to operators/ engineers.  Floppy disks are no longer used during testing, now switched to 3rd party software which is available via the 3rd party’s website.  Machines are updated by Martin/ Arek. Further investigation found that the software updates were not being controlled and there was no formal mechanism for checking to see that the software on each test rig was the most current. |  |  |  |  |  |  |  |  |  | Compliant
Process, function or area assessed: |  |  | Final Inspection
Evaluations and Conclusions |  |  |  |  |  |  |  |  |  | Outcome |  | Deficiency Ref |  | Owner
The final inspection area was a little messy.  Nobody was on inspection during the audit, but the bench was predominantly used by Zakk Altaire.   Further investigation found that the software updates were not being controlled and there was no formal mechanism for checking to see that the software on each test rig was the most current. |  |  |  |  |  |  |  |  |  | Compliant
Process, function or area assessed: |  |  | Spares returned to customers
Evaluations and Conclusions |  |  |  |  |  |  |  |  |  | Outcome |  | Deficiency Ref |  | Owner
Check during next audit. No product available to audit against |  |  |  |  |  |  |  |  |  | Compliant
Process, function or area assessed: |  |  | Despatch and Packaging
Evaluations and Conclusions |  |  |  |  |  |  |  |  |  | Outcome |  | Deficiency Ref |  | Owner
The trial on reusable wooden packaging for the P86’s is now over and decided not to progress, alternative more suitable cardboard boxes have been sourced. |  |  |  |  |  |  |  |  |  | Compliant
During the last audit concerns were raised by [NAME] and [NAME] over some of the weights of the products being handled. Total packaged weights have now been identified and added to the label, along with the box id number which ensures consistency in the type of box used for each product. |  |  |  |  |  |  |  |  |  | Compliant
The Sealed Air engineer has now trained [NAME] and [NAME] (training certificates available beside the instapak machine). |  |  |  |  |  |  |  |  |  | Compliant
Process, function or area assessed: |  |  | Invoicing
Evaluations and Conclusions |  |  |  |  |  |  |  |  |  | Outcome |  | Deficiency Ref |  | Owner
Check invoicing during QA audit |  |  |  |  |  |  |  |  |  | Observation |  |  |  | AD
Process, function or area assessed: |  |  | Process Monitors
Evaluations and Conclusions |  |  |  |  |  |  |  |  |  | Outcome |  | Deficiency Ref |  | Owner
Results are available for key process monitors (DOA, IRC, CHRs, OTD). Status reviewed during the MMRs. |  |  |  |  |  |  |  |  |  | Compliant
Process, function or area assessed: |  |  | General
Evaluations and Conclusions |  |  |  |  |  |  |  |  |  | Outcome |  | Deficiency Ref |  | Owner
The area is well controlled improvements are being identified and implemented. |  |  |  |  |  |  |  |  |  | Compliant