Client QA Audit Testimonials

Hi Andrew,

Good to meet yourself and Lee again along with the ACL Team.

Comments:

• The site is well organised, in good state of repair and infrastructure.
• FIFO was seeb to be is use within the SM department.
• The site uses FOXii computer-based business management system that it well-structured and developed in house.
• SM Lines are regularly maintained with QF61 Maintenance Schedule in-place found completed with works instructions in-place.
• Calibration is maintained in good order using asset register.
• Change request notification to manage drawings changes etc is in place and well managed.
• Production Folder for XXXXX product was found completed with all relevant processes signed off.
• Good Inwards well controlled.
• Production Manager demonstrated kitting of jobs and how all products are managed with systems showing status of all jobs in SM, AOI, Inspection & Test.
• Delivery Notes and D of C along with traceability details all checked and matched Production Job Cards in -place.

Well controlled systems in place, processes well demonstrated by all involved in the audit.

Thanks for the hospitality, look forward to seeing you next time.

This audit was conducted against the ISO 13485:2016 standard & FDA 21 CFR Part 820 - Quality Systems Regulation (QSR). 21 CFR Parts 801, 803, 806 and 807 (as applicable). Based on the evidence, ACL has adequately incorporated risk management into assembly/service processes.

• Review of Supplier File and Certifications found in good order with certifications provided with Quality Agreement updated to MDSAP requirements.
• Change Notifications provided for present XXXXXX Product, all well documented and register. Changes provided are improvements to processes. ACL Controlled procedure also provided.
• Document and Records evidence found in good order with various requested DHR documents provided, along with ACL controlled procedure.
• Provide evidence of an ACL Management Review, well documented with XXXXX covered.
• Purchasing - Current Supplier List, evidence of supplier evaluation, evidence of purchased product verification provided and verified.
• Monitoring & Measuring – Various Calibration Records provided with external certificates in good order. Asset Calibration Schedule in use. ACL Controlled procedure provided
• Examples of Supplier non-conformances provided with pictorial evidence, showing actions taken and verified, showing risk to business matrix. ACL Controlled procedure also supplied.
• Pictures of service and assembly areas provided, well controlled with new product on shelving and labelled accordingly.
• No corrective action verifications required from previous audit or this audit.
• Excellent result.

ACL service is in compliance.
At this time there is no need to increase the routine audit frequency.
XXXXXX continues to believe ACL operates a well‐controlled managed system and service organization and will retain continuous status as an Approved Supplier.

All looks good, thank you so much again for all the documentation provided you always make the process run smoothly and thank you and team for the time taken.

Hi Andrew & Simon,

Thanks for the hospitality during my visit, great to meet you both.
Thank you for the site tour it was good to see the various areas and how the product flows, very impressive.

• Suitable controls are in-place for the sample source.
• Risk assessments carried out.
• Local Rules in-place showing controls and checks.
• Source registry is available and up to date
• Periodic inspections being undertaken at least monthly
• ID tags legible and appropriate
• Trefoil warning symbol clear and legible

Thank you for getting the documents copies over so quickly.

Best regards,

Hi Andrew,

Just like to say my appreciation for the hospitality during my visit.
Another good site tour of facilities with knowledgeable staff in all areas, great to see.
No major/minor comments found during the audit, from my opinion again you are doing a great job in guiding ACL forward which is always refreshing to see in a supplier.
Quality and controls are excellent, along with all the standards at ACL, you are a credit sir, I don't know how you find the time.

Please pass my appreciation again to the team and thank them for their efforts.
I must say again, moving forward ACL are going to be a key supplier in the growth of both our businesses, very happy to have such great feedback to give out again internally to stakeholders.

Have a great weekend all!

Best regards,

Good morning Andrew,

Thanks for the time and showing XXXXXX and I around ACL, the visit was both informative and useful.

• ACL has good facilities and infrastructure
• ACL is well structured
• Personnel are well versed, regarding their processes
• Personnel are well trained in the process’s tasks given
• Works Instructions via short cuts on PCs found available
• Traceability ticks all boxes and is important to XXXXXXX
• Work areas are clean & tidy
• Calibration systems are good and well controlled
• In house test facilities available with possible test jig build if required

The audit report has been submitted to move to the next stage of on-boarding.

I am sure XXXX will be in touch regarding this at which stage we can hand over all the documentation associated with build etc.

There were no barriers arising from the audit which would cause us concern.

Enjoyable audit/visit.

Hi Andrew,

Thank you for your time last week and supporting the Audit in the best way possible due to the circumstances.

• Review of Customer requirements was undertaken using Business Impact (Risk) Analysis (Contract Review).
• Production Job Card for product picked was found completed covering verification stages of build & inspection to packaging.
• All product boards have Bar-coded serial numbers applied.
• Works Instructions for operations linked to appropriate ACL PC's.
• QF61 Maintenance Schedule for Jan-22 includes safety checks including e/stops. Environmental & Safety checks carried out.
• Calibration Schedule in-place.
• Approved Suppliers List is checked monthly for updates, identified on the system as red.
• Delivery Note Received, Detailing part and reference numbers, to PO.
• C of C Stated at the bottom of delivery note Received.
• ACL Part number with Barcode Traceability.
• Sample taken, digital vernier, picture & cal cert provided.
• Sample taken, Fluke 45 Digital Multimeter, Picture & Cal Cert Provided
• Training record taken from production job card for JS.
• Sample Picture AOI inspection area showing good clean environment.
• Corrective/preventative actions identified with actions taken.

Summary:

All aspects covered. Well controlled systems in place. Good clean environment.

Videos provided showed good knowledge of processes and personnel involvement.

Thanks to all involved.

Hi Andrew,

Allow me to thank you for your time today to complete our audit.

• Evidence of continuous improvement being made in various departments and more equipment resource purchased.
• Evidence of other approvals and external audits ATEX, FM, CSA etc.
• Prestigious customer base with new customers over the period.
• On Time delivery is good with PS now ordering ahead of schedules.
• Good Supplier chain demonstrated with approved suppliers list.
• Clean & tidy premises with different cells allocated.
• Good Anti-Static controls. ESD Protection observed within areas
• Production Files, Job Cards for PS product found in good order and completed (pictorial evidence taken and recorded).
• Conformal Coating area found in good order with Works Instructions in place.
• New Pick N Place Machine ordered
• Foxii ACL Computer System demonstrated for purchasing, order & build processes.
• Kitting demonstrated with the Production Manager, along with PCB storage and instructions.
• Quality Control Records found completed for the LDT Filter LF02.
• Calibrated Temp Mole used for Monitoring the Reflow Oven each month.
• AOI Demonstrated with inspection processes monitored.
• Employee Notice Board found with up-to-date policies & KPIs.

Summary:

ACL continue to be a very quality conscious supplier who pride themselves on the quality of their work. The level of service is excellent and they are prepared to go that extra yard for us in the event that there is ever a need or requirement.

ACL are capable of large batch quantities but can also specialize in smaller batch quantities which similar competitors may not want to undertake.

ACL also will also take on prototype work in order to help customers with new products for approval etc.

Audit Summary:

• Assembly of XXXXX in-line with associated controlled documentation:
• Assembly Drawings found compliant to controlled documentation and Chargepoint controlled register. Found to be in good use at time of audit.
• Production Job Cards in use and completed within Production Files for product ATEX in production.
• Quality Control Records found completed by appropriate personnel.
• Material Certificates provided for the Hub manufacture found to be in order.
• Training Records well controlled with Training Matrix for personnel within audit process with hyperlinks to relevant training records.
• Effectiveness of training noted.
• Records of Calibration checked found well controlled with appropriate certifications various examples provided as supporting evidence.
• Copies of delivery paperwork for various deliveries provided with D of C indication of serial numbers.
• Final Check/Test data provided for various deliveries all good.
• Quality Control Records, Delivery Notes and C of C sighed off.
• Good well controlled system.

Thank you for all the info provided, it's much appreciated.

This audit was conducted against the ISO 13485:2016 standard. Based on the evidence provided, ACL has adequately incorporated risk management into assembly/service processes.

• Review of Supplier File and Certifications found in good order with certifications provided.
• Change Notifications provided for present XXXXXX Product, all well documented and register. Controlled procedure also provided.
• Document and Records found in good order with various requested DHR documents provided as evidence, along with controlled procedure.
• Provide evidence of an ACL Management Review, well documented.
• Purchasing - Current Supplier List, evidence of supplier evaluation, evidence of purchased product verification.
• Monitoring & Measuring – Various Calibration Records provided with external certificates in good order. Asset Calibration Schedule in use.
• Examples of Supplier non-conformances provided with pictorial evidence, showing actions taken and verified. Controlled procedure also supplied.
• Pictures of service and assembly areas provided, well controlled.
• No corrective action verifications required from previous audit or this audit.

ACL service is in compliance.
At this time there is no need to increase the routine audit frequency.
XXXXXX continues to believe ACL operates a well‐controlled
service organization and will retain continuous status as an Approved Supplier.

All looks good, thank you so much for all the documentation provided makes the process run smoothly and thank you for your time.

Hi Andrew

This is great! Thanks for your time today and providing below support data:

Document References:

ISO 9001:2015 Certificate.
Production Job Card - complete with requirements and sign offs
Quality Control Record – showing shipment details, quantities etc.
Sample Training Records – provided for personnel who worked on the product assembly
Training Matrix (Snap Shot) – showing personnel and processes.

Many thanks

Have a good weekend!
Best regards

Hi Andrew

Thank you for taking the time to go through the below points:

Quality Approvals
Internal & Supplier Audits
Doc Control
Control of Subcontractors (suppliers)
Good In/Out & Storage
Identification & Traceability
Inspection & Testing
Calibration
Non-Conformances
Contract Review
Competency
XXXXXX Product audit and overview covering Quality Records, Job Cards, Delivery Documentation, Critical Parts Check, Inspection & Test Results, various pictures covering processes, Potting data received.

All found in good order, thanks again.

Good Morning Andrew,

It was good speaking today and thank you for your input in reviewing our Quality Plan & Agreement in-line with the ISO/IEC 80079-34-2018 standard.

After our review and discussion, I’m happy that all is in place and have received documentation requested at this time.

QAN ATEX Certificate & Iso 9001:2015 Certificate have been logged on or system.

Thanks again

Morning Andrew,

Thank you for reviewing our Quality Plans for our products in light of changes from the new standard ISO/IEC 80079-34-2018.

• ISO 9001:2015 updated Certificate received.
• Updated ATEX Certificate (QAN) received.
• Confirmation of checklist reviewed and confirmed.

Many Thanks for your time and help with the above.

Regards

Thank you for going through our Quality Agreement and Ex questions today, regarding additional notifications including references to the standard ISO/IEC 80079-34-2018.

I have attached the new Quality Agreement, signed off by appropriate department members.
We have received the updated QAN & ISO Certificate.

I'm happy that all appropriate documentation is in place at ACL at this time and hope to get together in the near future.

Thank you

Morning Gents,

I just wanted to drop you both an email to thank you for your support and professionalism over the last couple of days not just in front of the DNV auditor yesterday but in general with me.

The audit went very well with the auditor impressed with the systems and documentation control in place in relation to our product.

I have been really impressed with the ACL operations in the times I have visited but this week in particular, being on the shop floor, meeting Ed and Scott, listening to the apprenticeship programme, it’s all very encouraging to hear.

I’m also looking forward to latch hawk production getting back up and running – we have learned a lot of lessons since the last production build which can hopefully mean we have an even better product this time around.

So thank you and all of the team again and I look forward to coming back up in a couple of weeks to see production in full swing.

Thanks.

Hi Andrew,

Firstly allow me to thank you for your time last week to complete our audit.
Additionally, James appreciated the time you offered to allow him to have a better understanding of the industry.

• ACL showed evidence of continual improvement with equipment purchased.
• Evidence of other approvals ATEX, FM , CSA etc.
• Prestigious customer base.
• On Time delivery is good with PS asking for product earlier in some cases.
• Good Supplier chain demonstrated.
• Clean & tidy premises with different cells allocated.
• Production Files, Job Cards for PS product found in good order and completed (pictorial evidence taken).
• ESD Protection observed within areas.
• Conformal Coating area found in good order with Works Instructions in place.
• Foxii ACL Computer System demonstrated for order & build processes.
• Kitting demonstrated  with the Production Manager, along with PCB storage and instructions.
• Quality Control Records found completed for the PS - ST101 Master Module.
• Calibrated Temp Mole used for Monitoring the Reflow Oven each month.
• AOI Demonstrated with inspection processes monitored.
• Employee Notice Board found with up to date documentation & KPIs.

Summary:
I was really pleased with the attention to detail that each department work to. The processes are well thought out, to the point where some inspections could be considered excessive. The fact that these additional checks are in place, offers me the reassurance that our product builds are being carried out with great care and attention.

This audit was conducted against the ISO 13485:2016 standard. Based on the evidence provided, ACL has adequately incorporated risk management into service processes.

• Copies of Certifications provided, agreements in file are current.
• Checklist reviewed showed few changes over the period.
• ACL facilities meet all requirements for the servicing of XXXXX products. The facility is well maintained, has appropriate climate control, work environments are clean and virtually dust free (pictures provided)
• A sample training card was provided as evidence of training to the ISO 13485:2016 standard demonstrating that effectiveness is proportionate to the level of risk.
• ACL is the CMO for XXXXXXX and is singularly qualified to perform all repairs.
• XXXXXXXX servicing is done in the XXXXXXX assembly area. Appropriate testing   equipment is available. Calibration record for R203 Radiometer & Calibration Certificate for Hipot Tester checked for calibration status and certification. Repairs are tracked separate from new system assembly and segregated.
• A “Traveler” accompanies the device from the time it is received until it is returned to the customer (no change). Pictures was taken as evidence.
• ACL provides customers with custom packaging for the shipment of devices for repair. Copies of shipping documents are kept electronically.
• Pictures are taken of each unit leaving ACL, prior to dispatch.

ACL service is in compliance.
At this time there is no need to increase the routine audit frequency.
XXXXXX continues to believe ACL operates a well‐controlled
service organization and will retain continuous status as an Approved Supplier.

This audit was conducted against the ISO 13485:2016 standard.
Based on the evidence provided.

• Documents & Records Control:
  ACL signs and incorporates XXX documents into manufacturing processes.
  Evidence of ACL internal document control is on Change Request Forms 19-03, 19-23 & 19‐42 (copies were provided as evidence).
  Yearly Back‐Up Recovery Log is current (sample was provided as evidence).
• ACL facilities meet all requirements for the servicing of XXXXXX products.
  The facility is well maintained, has appropriate climate control, work environments are clean. Picture taken of production areas for records.
• DHR & Final Release:
  Random check of DHR#s  DHRs for RH010354, MB010413, IH010143, BH010165
  All found completed.
• Monitoring & Measuring Calibration schedule is current. Samples provided/taken.
• Non‐Conforming Product:
  There haven’t been any major incidents of non‐conforming product in the past year.
  Samples of the BIA non-conformance reports and concessions provided as evidence of procedure.
  QF31 Risk Analysis on Non‐Conforming Product.

ACL manufacturing is in compliance.
At this time there is no need to increase the routine audit frequency.
At this time there is no need to increase the routine audit frequency.
XXXXXX continues to believe ACL operates a well‐controlled
manufacturing organization and in a good environment and will retain continuous status as an Approved Supplier.

ACL Assembly Controls was assessed against Q 414 M QU - Supplier Quality Assurance Requirements & ISO/IEC80079-34 – Explosive Atmospheres Application of Quality systems.

• Excellent Approval Status.
• Product Contract Reviews, Quality Record Sheets, Production Job Cards, Inspection Records, Delivery Notes & Declarations of Conformity found evidence and traceability from orders provided for assessment.
• Calibrated Equipment noted matched certificates and labels.
• ACL have effective process controls and procedures in place with on-going improvements noted to fulfil the requirements.
• No findings being identified against ACL during this assessment.

In summary ACL demonstrated effective controls in accordance with the approved control plan & also have shown very good vendor rating performance in 2019.

Hi Andrew,

Good to meet you too and thanks again for your time, please thank everyone at ACL.

Comments:

• The site appears well organised, in good state of repair and records were readily available.
• The site uses FOXii computer based business management system that it well understood was developed in house.
• BIA (Business impact Assessment) requires completing to manage factors such as lead time, or the order cannot progress.
• Change request notification to manage XXXXXX drawings is in place and well managed.
• An approved suppliers list was seen showing supplier certifications.
• Good Inwards well controlled.
• Production Manager demonstrated kitting of jobs and how all products are managed with systems showing status of all jobs in SM, AOI, Inspection & Test.
• 100% AOI & HD Scope Inspections.
• XXXX-XXX Product audit was carried out from quotation through to dispatch with samples taken with no issues noted.

Well controlled systems in place, processes well demonstrated by all involved in the audit.

Firstly like to thank everyone at ACL who took part in the audit process.

Feedback:

• Clean tidy environment found during tour of facilities.
• Well controlled good inwards process & traceability, through bespoke in-house computer system.
• Good Manufacturing process in-place with process plans and FMEA's in use and reviewed. Toured processes from SM to Packaging.
• For Supplier or Product issues uses a non-conforming 'BIA' (Business Impact Analysis) Report similar to formulised 8D reports. The impact to the business is assessed with a full investigation to identify the root cause and corrective action.
• Calibrations records and schedule in good practice.
• Training Matrix with built-in training instructions well documented and controlled.

ACL have good well controlled quality systems in-place with no issues noted during the audit.  Full component traceability was well demonstrated.

I would like to thank all at ACL for your time and hospitality during the audit.

• Controlled Work Instructions/SOPs are available at each stage of the production process.
• The company operates its own ERP system (FOXII), which controls all manufacturing processes and allows full traceability of components and finished product.
• Specific components are required to be physically verified against the specification (conductors/capacitors/resistors).
• An ACL barcode label is applied to every board to ensure traceability of the batch.
• Manufacturing requirements for each specific job are provided in a production file which accompanies the batch throughout manufacture.
• Checks and inspections are carried out at each stage of the manufacturing process.
• AOI (Automatic Optical Inspection). This checks the orientation and placement of the components on the board - 100% inspection
• Microscope inspection. 100% visual check of solvent joints.
• For any product found to be non-conforming a 'BIA' (Business Impact Analysis) is initiated. The full impact to the business is assessed and the issue investigated to identify the root cause.
• Risk and Opportunity' registers are available for both over-riding issues (context/interested parties) and critical processes (surface mount/lead and assembly)
• The quality plan (QF2) for each job also includes an FMEA

Audit Conclusion:
The audit demonstrated excellent control over processes at ACL and a robust Quality Management System.
No issues were raised, and the audit effectively confirmed the company's ability to provide the required service to XXXXXX XXXXXXX.

Hi all,

Again, I'd just like to reiterate my appreciation for the hospitality during the visit, always great to catch up with you guys.

No major/minor comments found during the audit, and from my opinion you are doing a great job in guiding ACL forward which is refreshing to see in a supplier - so thankyou again!

Please pass my appreciation to the team and thank them for their efforts also during our visit. Moving forward ACL are going to be a key supplier in the growth of both businesses, and I'm happy to have such great feedback to give out internally to stakeholders.

Have a great weekend guys!

Best regards,

This audit was conducted against the ISO 13485:2016 standard.
Based on the evidence provided, ACL has adequately incorporated risk management into service processes.

• Documents & Records Control:
  ACL signs and incorporates XXX documents into manufacturing processes.
  Evidence of ACL internal document control is on Change Request Form 18‐54.
  Yearly Back‐Up Recovery Log is current.
• ACL facilities meet all requirements for the servicing of XXXXXX products.
  The facility is well maintained, has appropriate climate control, work environments are clean and virtually dust free. Pictures taken.
• DHR & Final Release:
  Random check of DHR#s RH010228, RH010276 & RH010279 All complete.
• Monitoring & Measuring Calibration schedule is current. Samples provided/taken.
• Non‐Conforming Product:
  There haven’t been any incidents of non‐conforming product in the past year.
  Samples of the following documents from other customers were provided as evidence of established processes: QF24 Concession Request #1840 QF31 Risk Analysis on Non‐Conforming Product.

ACL manufacturing is in compliance.
At this time there is no need to increase the routine audit frequency.
At this time there is no need to increase the routine audit frequency.
XXX continues to believe ACL operates a well‐controlled manufacturing organization and will retain continuous status as an Approved Supplier.

This audit was conducted against the ISO 13485:2016 standard. Based on the evidence provided, ACL has adequately incorporated risk management into service processes.

• Copies of Certifications provided, agreements in file are current.
• Checklist reviewed showed few changes.
• ACL facilities meet all requirements for the servicing of XXXXX products. The facility is well maintained, has appropriate climate control, work environments are clean and virtually dust free (pictures provided)
• Training records for Mr. X. XXXXX and Mr. X. XXXXX were reviewed as a sample of training records. Both are current on assembly and servicing of XXX Products.
• A sample training card WI 032A was provided as evidence of training to the ISO 13485:2016 standard demonstrating that effectiveness is proportionate to the level of risk.
• ACL is the CMO for XXXXXXX and is singularly qualified to perform all repairs.
• XXXXXXXX servicing is done in the XXXXXXX assembly area. Appropriate testing equipment is available. Repairs are tracked separate from new system assembly.
• A "Traveler" accompanies the device from the time it is received until it is returned to the customer. Picture was taken as evidence.
• ACL provides customers with custom packaging for the shipment of devices for repair. Copies of shipping documents are kept electronically. 

ACL service is in compliance.
At this time there is no need to increase the routine audit frequency.
XXX continues to believe ACL operates a well‐controlled
service organization and will retain continuous status as an Approved Supplier.

ACL Assembly Controls was assessed against Q 414 M QU – Supplier Quality Assurance Requirements & BS EN ISO/IEC80079-34 – Explosive Atmospheres Application of Quality systems.

• Approval Status is Excellent.
• Contract Reviews, Quality Record Sheets, Production Job Cards, Inspection Records, Delivery Notes & Declarations of Conformity found evidence and traceability from orders provided for assessment.
• Calibrated Equipment noted matched certificates and labels.
• ACL have effective process controls in place with on-going improvements noted to fulfil the requirements.
• No findings being identified against ACL during this assessment.  

In summary ACL demonstrated effective controls in accordance with the approved control & also have shown very good vendor rating performance in 2018.

Thank you

Audit Summary:

• Assembly of XXXXX in-line with associated controlled documentation:
  • Assembly Drawings found compliant to controlled documentation.
    Found to be in good use at time of audit.
  • Job Cards in used within Production Files for product ATEX product going through production.
  • Quality Control Records & Production Job Cards found completed by appropriate personnel.
  • Training Records well controlled with Training Matrix for personnel within audit process with hyperlinks to relevant training records.
    Effectiveness of training noted.
  • Records of Calibration checked found well controlled with appropriate certifications
  • Quality Control Records, Delivery Notes and C of C sighed off.
  • Good well controlled system.

Summary:

• Factory Tour of operations and facilities.
• Goods Inwards controls demonstrated with barcode control of component.
• Production Manager demonstrated kitting controls and labelling.
• SM Line showing good controls with “Fist off” inspections carried out.
• 100% Inspection of all products carried out and demonstrated.
• Production File, Job Card and Quality Control Records shown for traceability.
• Leaded production work through carried out, works instructions in place.
• Calibrations Records in good control ad order.
• Delivery Documentation, D of C and Traceability Details demonstrated and provided as requested.

Overall very satisfied with controls in place for our new products.

Hello Andrew,

Audit Summary:

• Manufacturing in line with XXXXX XX and Interim documentation:
  • Training Records well controlled with Training Matrix with hyperlinks to relevant training records. Product training noted.
  • Interim documentation in place with ACL works instruction also in use.
  • Job Cards in use within Production Files for our products going through production, includes audit check stages.
  • Calibration & ESD Controls in place with equipment labelled accordingly.
  • Quality Control Records,Delivery Notes and C of C sighed off.
• Traceability:
  • Quantities are well controlled for products.
  • Rejects controlled via BIA (non-conformance) Reports.
  • Faulty parts are treated as above, controlled well.
  • Delivery of picked parts are checked through "Goods Inwards Inspection" with missing parts emailed initially to XXXXXX.
• ACL QMS:
  • Found documented and in place to ISO 9001:2015.
  • Internal audit system and schedule in place and controlled.
  • Change Request Forms used to share implemented changes.
  • Quality Policy found documented and displayed in reception & employee notice board.

Thank you and Lee for your time during the audit,

Hi Andrew

Thanks for you hospitality yesterday the visit was very informative and welcoming. Review Below:

• Quality System well documented & controlled in-line with ISO 9001:2015.
• Quality Trends are in-place with KPIs and analysis carried out.
• Company Objectives in place, detailed and shared with employees.
• Top Management co-ordinate the “Management Review” meetings with reviews maintained.
• Appropriate components are used on our product in-line with our BOMs.
•  Continual improvements could be seen through during factory tour.
• Corrective action analysis found well controlled, using BIA (Business Impact Analysis) Reports, covering Customer, Supplier & Internal issues.
• Training Matrix in-place with hyperlinks to individual personnel training records, reviewed & controlled.

Effectiveness of training is reviewed within the records.

Thanks and Kind Regards,

Hello Andrew,

Please refer to below general review notes:

Production and documented review audit carried out:

• Good Inwards controls audited, found well conversed and controlled.
  Internal bespoke computer system showed excellent controls of incoming products.
• Production review & controls audited, found Production Files & Job Cards in use, samples taken, found completed, in good order.
  Production Manager showed good controls of production flow through the bespoke computer system.
•  100% Inspection carried out on all products with barcode labelling system in-place.
• Calibration Equipment well controlled with equipment labels showing status.
• Documentation controls in place to new standard ISO 9001:2015, Quality Management System is well documented & controlled.
• Traceability to component level is excellent.

Had a great visit the other day, I was very impressed by your company.

Thanks: (Overseas Quality Senior Engineer).

Hi Andrew

Thank you again for your time today and your assistance in keeping us on track with audits.

General Summary from Audit Checklist:

• QMS Control of Records – found Hard & Electronic records well controlled, with majority of records now kept electronically.

Procedure - Control of Documented Information supplied for reference.

• Resource Management – Adequate resources within production areas with maintenance schedules in place. Records provided for reference.
  Competence – Training Record Indicator & Review documents in place with training matrix. Evidence provided, sample docs for reference. Effectiveness of training found reviewed. Personnel made aware of objectives in place.
  Environment – New LED lighting installed, areas kept clean & tidy at all times.
• Customer Complaints – Business Impact Analysis (BIA) reports/registers in place for reporting customer complaints, sample provided for reference.
• Purchasing – Procedure Control of Purchasing, External Process & Information provided for reference, detailing supplier assessments, goods inwards controls.
  Samples of supplier monitoring data provided. Sample supplier non-conformance provided. Sample PO and Cert reviewed.
  Calibration Records and Schedule reviewed, sample records provided.
  Packaging – Procedure Preservation provided for reference. Sample delivery notes, C of C provided.
  Change Request Form reviewed, sample provided. Procedure “Control of Change to Documented Information” provided for reference.
• Servicing – Works Instructions provided for review of XXXXXX Products. Electronic Service Report in use. BIA Reports used for XXXXX warranty products.
  Products for repair are defined via serial numbers in work area.
  Sample manifests provided for XXXXX products.
• Control of Non-Conforming Product – Procedure “Control of Non-Conforming Product “ provided for reference. BIA Reports in use for non-conforming products, sample provided.

 All above found well controlled & documented in-line with our audit checklist.

Hi Andrew and Lee

I just wanted to say thank you for your time and hospitality yesterday during our audit.

I continue to have great confidence in your controls and business systems. 

Summary:

• QMS Overview - Non-Conformances and Customer Complaints investigation found new format document in good use.
• Control of Documents - well controlled.
• Supplier Management - controlled well.
• Contract Review - well controlled, document reviewed.
• Goods Inwards - process demonstrated, in good control.
• In process controls - sample XXXXX production file reviewed, maintained.
• Product Release - Delivery Note, C of C reviewed, maintained.

General Summary:

• Tour of factory & facilities, found clean, tidy and organised.
• General Review of production files & data found in good order.
• Overview of the Quality System found well managed & controlled.
• New "ATEX" product discussed with suggestions raised by ACL & Customer to improve product assembly.
• New order to be placed with ACL.
• ACL to be added to "ATEX" certification.

Hello Andrew,

Thank you for your time – our visit was interesting and helpful. Thanks also of course to the others involved and for the documents you kindly sent.

I attach a copy of our report for your interest and, hopefully, signature!

Thanks to all at ACL.
Journey home was uneventful and the weekend good – hope yours was too,

Report Info:
During our visit we saw a well-run company with an effective management system.

ACL are audited against ISO 9001 and IEC 80079-34, both by UKAS accredited companies:
- Audit report from last ISO 9001 audit was seen;
- QAR from last IEC 80079 audit was seen.

ACL is an existing supplier of our product range and a summary from this audit:

• Quality Record Sheets, Production Job Cards, Inspection Records, Delivery Notes & Declarations of Conformity found evidence from orders given.
• Calibrated Equipment matched certificates and labels.
• ACL have effective process controls in place to fulfil the requirements
• Demonstrated by no findings being identified against ACL during this assessment.  

Thank you for your time

Audit Summaries:

This assessment has been carried out as part of XXXX Aerospace planned supplier surveillance activities 2017 and was identified as candidate for Boeing commercial aircraft (BCA) joint technical assessment (JTA).

ACL remain an approved supplier grade A to XXXX Aerospace and our sub tiers.

• ACL demonstrated awareness of requirements.
• Purchase Orders and build information flowed through organisation.
• ESD controls in place, along with ESD Containers.
• Work areas clean & tidy.
• In process checks, Inspection and final test inspection carried out.
• ACL produce required material to support FAI (First Article Inspection)
• Preventative maintenance for machines & equipment demonstrated.
• XXXX Aerospace Approved Suppliers used.
• Components & materials inspected upon receipt.
• Quality Records supporting manufacturing are maintained.

ACL demonstrated that plans are in place to obtain ISO 9001 2015 and showed commitment to ensure applicable customer requirements are identified, and steps taken to ensure the desired result is achieved.

The auditor would like to thank the team at ACL for hospitality openness and support thought out the audit.

Audit Report break down and summary:

Contract Review:
Process in place with clear documented evidence of review. Advanced quality planning is available on request and demonstrated. Clear and legible signatories showing responsibilities for review

Production:
Good controlled process, job cards are detailed, in order with full accountability and traceability control detailed.

Maintenance:
TPM well managed as per the demonstrated plan. Maintenance Works instructions within area controlled. Supplier Control: Approve Suppliers List electronically managed by ACL with reminders set in the company software to alert when certificates coming up to expiry date. Suppliers are monitored on a certificate life basis and an extra notes section allows the inclusion of any special requirements or alerts for poor quality from a particular supplier etc.

Process Control:
Excellent level of process control maintained with the routing packs as well as photographic process instructions for each production operation, linked via short-cuts on PCs and upon shop floor.

Inspection:
100% visual inspection performed on every component. More detailed testing can be performed but this is as per the customer request. Recorded upon job cards.

Training:
A well planned and maintained Training Matrix is set-up with training records hyperlinked to the matrix.

Summary:
ACL seem to have well established, processes that are controlled by well-established and documented methodology. Process control is to a high level with detail to continuous traceability maintained. Operatives have access to appropriate work aids to fortify the quality of the process. There appears to be a good variety of customers from a full spectrum of the market which would instill confidence in their longevity in the market place.

The visit consisted of meeting the Quality Manager and Quality Director for a site tour to see how they handle products including the XXXXXX  XXXX  XXXX.

They operate a lot of processes as well as SMT and prototyping capabilities.

The staff on-site are very friendly with lots of knowledge within various product ranges including non-automotive. 

Operators are open to talk about their processes and answer any challenging questions put to them from myself.

Management were very supportive in taking on board improvement suggestion with a great ‘can do’ attitude.

A great team overall with an open attitude to working closer with XXXXXXX to improve quality at both sides.

Keep up the good work and keep focus on delivering trouble free devices to XXXXXXX / XXXXXX.

Thank you

On Arrival: -

The reception area provided a professional aspect with a large glass panel providing a visual view of the clean production shop floor, along with our company and personnel details which were displayed on a large LCD screen.

A brief meet and greet then followed with Arthur Woode, Lee Williams and Andrew Colduck which outlined their customer focus and general Professionalism.

Andrew Colduck then gave us a full Factory tour from goods- in to final Dispatch, the facility showed good 5s in every area and had a very high standard of cleanliness throughout.

Audit Conclusions: -

Very Professional and immensely customer focused, competent and a sound understanding throughout the work force of customer’s requirements and the Quality required to succeed with ongoing continuous improvement from the Quality Department.

With this in mind I would have no issue in recommending Assembly Contracts (ACL) as a supplier.

Wanted to thank everyone for the warm hospitality and great support during my visit to ACL.

A special shout to Derek and Andrew for assisting me with the audit, greatly appreciated.

Looking forward to a long and successful enterprise with all of you at ACL.

A well-controlled documented system, everyone involved in the audit process answered the relevant questions with knowledge of their various processes in-line with the documented system.

Many thanks again for your support in this visit.

At time of visit processes observed were under good control and clearly the company is continuing to improve its approach on business continuity and risk

Evidence of physical security procedures.
Visitor procedures were followed on arrival.
Evidence ACL has continued to develop and improve its approach to business continuity and risk as Internal audit plan viewed and reports seen.
Verified data retention.
Soldering iron seen on the xxxxxxxxxxx line. Document written by Quality Mnager "lead free hand soldering iron" specified desired operating temperatures. Evidence of testing soldering irons.
Evidence of ESD procedures.
Password policy - Staff awareness in the xxxxxxxxxxx area evident.
Provided evidence of training records with improvements being made to training records & matrix.

Good Morning Derek & Andrew

Audit Report break down and summary:

Contract Review:
Rigid process with clear documented evidence. Advanced quality planning is available on request and demonstrated. Clear and legible signatories for the operation.

Production:
Well controlled process, routings are detailed, in order with full accountability and traceability control detailed.

Maintenance:
TPM well managed as per the demonstrated plan.

Supplier Control:
Electronically managed ASL with reminders set in the company software to alert when certificates are expired. Suppliers are monitored on a certificate life basis and an extra notes section allows the inclusion of any special requirements or alerts for poor quality from a particular supplier.

Process Control:
Excellent level of process control maintained with the routing packs as well as photographic process instructions for each production operation.

Inspection:
100% visual inspection performed on every component. More detailed testing can be performed but this is as per the customer request.

Summary:
ACL seem to have well established, rigid processes that are controlled by well-established and documented methodology. Process control is to a high level with detail to continuous traceability maintained. Operatives have access to excellent work aids to fortify the quality of the process. There appears to be a good variety of customers from a full spectrum of the market which would instill confidence in their longevity.

Delivery
No. of Shipments 6
No. of Late Shipments 0
Delivery Performance - % on time 100%
Delivery Performance Grade 1

Quality
No. of Units Delivered 260
No. of Reject Units 0
Quality Performance - % acceptable 100%
Quality Performance Grade 1

Overall Supplier Performance Grade 1

Dear Derek/Andrew/Lee

Many thanks again for making us so welcome during our visit last week and for giving us an insight into your operations.
Both David and I were very impressed with what we saw and this is reflected in the attached report. Please let me know if there is anything in the report which you feel should be amended.

We will keep you updated with the progress of the project and hope to see you again soon.

Best Regard

Summary:

The audit demonstrated that manufacturing processes at ACL are efficient and effectively controlled and there is full traceability of components.
All production personnel demonstrated good skills and knowledge for their roles and training is well controlled.

Good morning Derek and Andrew

Thanks again for your hospitality and co-operation during our recent visit. Both Gavin and I were very impressed with ACL, both in terms of the robust systems but also the co-operation and enthusiasm shown by everyone we spoke to.

As promised I have attached copy of the audit report. As explained on the day we did not identify any deficiencies during our visit.

Kind Regards

Thanks again for all your time yesterday showing Thatcham your quality documents and systems. It was clear that they were impressed and reassured about the systems/processes you have in place.

It's great to pass the assessment again without any issues.

Summary:

The business and processing areas were well presented and production areas followed clear stages using the company's on-line routing system. Positive actions in areas identified at last visit were evident. No new issues were found on this visit. Of particular note was the embracement of risk analysis in connection with business recovery.  This has included taking our recovery insurance.

Today we had our product and manufacturing audit by Thatcham, covering all our products.

We achieved a completely clean bill of health with no non-compliance's, which was an excellent result.

Needless to say, big thanks to ACL for the work they continually do to maintain this standard.

Regards