Spreadsheet: 62520d1263447025-copying-cells-from-one-worksheet-to-another-based-on-certain-conditions-draft-hot-list-2
Sheet: CMS

Element / Module | Question Number | Rating | Finding | Reference | Root Cause | Corrective Action | Assigned To | Target Completion Date | Actual Completion Date | Status / Comments | TCCMS CAP Audit             ([NAME])                Status / Comments | Days Past Due
3.2 Management Review
 | 1 | Improvement Opportunity | The Management Review "inputs" do not include an overall review and analysis of the status of corrective and preventive actions. | QMS 3.2.6                  Question 8 | The PHRED (continual improvement) system was managed in a different meeting. | A review and analysis of the status of corrective and preventive actions will be addressed during the Management Review meeting. | Hampton/Holt | 2009-03-31 00:00:00 | 2009-03-24 00:00:00 | Corrective and preventative actions were incorporated into the 3/31/09 Management review meeting.  This will continue to occur in future Management review meetings. | The next Management Review meeting is scheduled for 3/31/09.  Need to add that [NAME] has and will continue to review in meetings
3.3.1 Documentation
 | 2 | Improvement Opportunity | The records matrix and calibration matrix are not under document control | QMS 3.3.1                    Question 1 | The records matrix and calibration matrix had not been controlled in [NAME] due to numerous updates and changes that were being made up to the time of the audit. | Control both of the matrixes in Livelink system. | Barker | 2009-02-01 00:00:00 | 2009-01-19 00:00:00 | Has been controlled in Live link. | Has been controlled in Live link.
 | 3 | Improvement Opportunity | The Management System Manual (rev. 11/26/08) does not exclude from the plant's scope the determination and review of contractual requirements. | QMS 3.3.1                    Question 1 | SPC does not work directly with customers to determine and review contractual requirements.  This was not reflected in the Management System Manual as an exclusion. | Edit the Management System manual to reflect that SPC does not perform the determination and review of contractual requirements. | Vanderhall | 2009-02-01 00:00:00 | 2009-01-27 00:00:00 | Edits have been made to the Management System Manual.  Manual will be placed through the work flow for review. | Edits have been made to the Management System Manual.  Manual will be placed through the work flow for review.
3.5 Material and Product Integrity |  |  | 3.5.1 Sweeteners:
 | 4 | Minor Nonconformance | From June 1, 2008 to November 15, 2008 only five (5) of the sixteen (16) tankers of HFCS 55 had records of inspections of the incoming sweetener and seal checks that were recorded into the lab information system (LDMS).  Corrected | BO-RQ-010, 018, 019, 021, 022, 024, 036, 012.  Question 5 | Truck tanker receipts were not handled with the same paper work process as rail cars.  The data from the trucks was not entered in the LDMS data base due to this process failure. | Review HFCS receiving policy with all Blenders.  Ensure tanker receipts are added to paper work process and data added to the LDMS.  Raw Material Coordinator and [NAME] to follow-up and review data in LDMS to insure compliance. | Barker | 2009-01-01 00:00:00 | 2009-01-01 00:00:00 | Complete. Receiving of HFCS policy was reviewed with Blenders and training will be documented. | Some confusion as to where the training was documented and also missing the training records for one of your blenders.
 | 5 | Minor Nonconformance | The [NAME] storage room is not capable of maintaining 22-33 degrees Celsius (72-86 degrees [NAME]) for HFCS 5, i.e., incapable of cooling the sweetener.  The HFCS 55 temperature was up to 90 degrees F on several occasions in July and August of 2007 during Syrup batching. Repeat | BO-RQ-205 | Plant receives HPFS-55 at 95 F.  The plant does not have the capability of cooling the HFCS before it is used for batching. | Capital improvements to sweetener storage would be needed.  Plant will ensure requirements are evaluated when sweetener storage is upgraded. | Barker | 2010-12-30 00:00:00 |  | N/A | N/A
 |  |  | 3.5.2 Concentrate & Beverage Base:
 | 6 | Improvement Opportunity | There is no evidence of receiving inspection for concentrate and beverage base as required by the Incoming Raw Materials Inspection for Visual Damage or Tampering Policy CQAADO000016. There was no record of the required Bill of Lading stamp with trailer damage or odor, pallet damage, receiving signature as required by the policy. | BO-RQ-020/ BO-RQ-200 Question 1 | Plant did not follow the same process for receiving concentrate and beverage base as required by CCNA. | Plant will update current stamp to include all required inspections for incoming concentrate and beverage base.  Management will document training to policy for receiving. | Barker | 2009-02-01 00:00:00 | 2009-01-16 00:00:00 | Stamps have been received. | Stamps have been received.
 |  |  | 3.5.3 Auxiliary Material:
 | 7 | Improvement Opportunity | The RO water system was recharged on 9/27/08 and on the UV Towers on April 2006, but no retain samples for the granulated activated carbon were available. The plant stated that these were inadvertently discarded. | BO-SP-285, BO-SP-286, BO-SP-287 | Retained carbon samples were destroyed doing a plant 5-S project.  The samples were not labeled and stored to ensure these were not destroyed. | The plant will designate a storage area in the QA Managers Office for retained carbon samples.  These will be marked as "Do Not Destroy Retained Carbon Sample" | Barker | 2009-01-15 00:00:00 | 2009-01-10 00:00:00 | Complete. Carbon samples were retained from carbon change dated 01/10/2009 | Person normally responsible for this was out, so there was confusion as to the location of the sample.  Eventually it was found, but container was not labelled.
 | 8 | Improvement Opportunity | There is no evidence that processing aids such as CIP chemicals and water treatment chemicals are inspected and recorded for package integrity, identification and quantity delivered against a delivery sheet, product appearance and the presence of any visible damage or foreign matter, batch number, availability and conformity of the documentation as agreed in the conditions of the purchase contract. | BO-RQ-280 | Plant did not follow the same process for receiving chemicals as required by CCNA. | Plant will update current stamp to include all required inspections for incoming chemicals.  Management will document training to policy for receiving. | Barker | 2009-02-01 00:00:00 | 2009-01-16 00:00:00 | Stamps have been received. | Bulk chemical deliveries were stamped, drums were not.
3.6 Process Integrity |  |  | 2.6.13 Machine Guarding E/S:
 | 9 | Improvement Opportunity | The drill presses in the fleet shop, maintenance shop, maintenance cage area and contractor area were not guarded at the point of operation. | 29 CFR 1910.212      Question 3 | Plant was not aware of required guarding of drill presses. | Purchased required guarding and installed.  Issue corrected during audit. | [NAME] | 2008-12-04 00:00:00 | 2008-12-04 00:00:00 | Complete. Due to the fact that the plant was unaware of guarding requirements for drill presses, the topic will be discussed in the next monthly safety meeting. | Complete. Due to the fact that the plant was unaware of guarding requirements for drill presses, the topic will be discussed in the next monthly safety meeting.
 |  |  | 2.6.14 Fire Control and Combustible Materials E/S:
 | 10 | Improvement Opportunity | There are two exits in the ammonia compressor room. However, only one has a lighted exit sign. | Life Safety Code Requirement Question 6 | Signs were not installed. | Installed required signs.  Corrected during audit. | Holt | 2008-12-04 00:00:00 | 2008-12-04 00:00:00 | Complete | Complete
 | 11 | Improvement Opportunity | "No Smoking" signs were not posted at the outside Fleet fuel island. | Fire Control Requirements Question 7 | Signs were not installed. | Installed required signs.  Corrected during audit. | Holt | 2008-12-04 00:00:00 | 2008-12-04 00:00:00 | Complete | Complete
 |  |  | 2.6.15 Material Handling Equipment E/S:
 | 12 | Improvement Opportunity | Load rating specifications were not posted on the two new hoist rails recently installed in the WWTP (Blower Building). | Material Handling Requirements Question 3 | Signs were not installed. | Installed required signs.  Corrected during audit. | Fuentes | 2008-12-04 00:00:00 | 2008-12-04 00:00:00 | Complete | Complete
 |  |  | 2.6.22 GMP
 | 13 | Improvement Opportunity | Standing water noted near the RO water treatment area and on the floor above the clear well. | BO-RQ-200, BO-RQ-195 Questions 6 | Floor design does not allow for proper drainage. | Capital improvements for repairing the floor are needed to improve drainage.  Sanitation will monitor and clean until capital improvements occur. | Barker | 2009-12-31 00:00:00 |  |  | What is the status?
 | 14 | Improvement Opportunity | Some floor pitting and standing water outside the filling rooms for fillers 5 & 6 and fillers 3 & 4. | BO-RQ-200, BO-RQ-195 Questions 6 | Water, chemicals, and age of the floor are contributors to the damaged floor. | Repair floor | Holt | 2009-03-01 00:00:00 | ON GOING | Capital request has been approved and repairs are in progress.  Repairs will be on going and are being managed through the PM system.
 |  |  | 2.6.23 Proportioning, Carbonating & Filling:
 | 15 | Improvement Opportunity | The plant does not perform torque every hour as required. Torque testing is run every 3,000 bottles/capping head. | BO-RQ-170/PK-SP-080 Question 4 | CCBCC policy is following the OEM recommendation of the capper equipment for frequency testing. | CCBCC Quality Corporate will review with the RTM on compliance. | Barker/Shullaw | 2009-03-01 00:00:00 | Closed. |  | In process.  Improvements made.  Shullaw made a decision to maintain the testing frequency.
 | 16 | Improvement Opportunity | The plant did not demonstrate process capability for the following: o Torques on all lines indicate [NAME] of < 1.0  o Net Contents – [NAME] has a [NAME] value of  <1.0 | BO-RQ-174 Question 14 | PTOC closures and [NAME] capping systems have not shown capability at this point.  Net content on Ln4 [NAME] is less than 1 due to overfilling. | Plant is working with suppliers to improve the [NAME] on torques.  There is a PHRED problem currently being worked to improve capability.  Plant will evaluate all vent tubes on  Ln4 and establish correct lengths. | Barker/McNee | 2009-03-01 00:00:00 |  | Cuts performed on 1L, 20 oz., and 24 oz.. 1/2 L and 12 oz. needed. | Cuts performed on 1L, 20 oz., and 24 oz.. 1/2 L and 12 oz. needed.  New projected due date:  Still need to see data.
 |  |  | 2.6.24 Syrup Manufacturing
 | 17 | Improvement Opportunity | Not all storage requirements for final syrup are met: [NAME], diet coke was blended on 11/26/08 9:00 PM with packaging at 10:00 AM on 11/28/08 exceeding the requirements for 24 hours from the time of syrup preparation to syrup use. | BO-RQ-045 Question 6 | Plant schedule has diet syrups produced and held for more than 24 hours. | Review current scheduling opportunities to ensure plant will not hold Diet syrup longer than 24 hours. | Barker/Durham | 2009-03-01 00:00:00 | 2009-03-01 00:00:00 | Complete.  Management practice to ensure Diets aren't kept over the weekend. | Complete.  Management practice to ensure Diets aren't kept over the weekend. Is there anything in writing?
 |  |  | 2.6.25 HACCP Quality
 | 18 | Minor Nonconformance | The process for considering legal and statutory requirements is not documented. | TCCMS Ev. 3, HACCP 5.2 Questions 2, 3, 5, 6, 8 | HACCP plan did not clearly define where legal and statutory requirements were evaluated. | Update HACCP plan and ensure HACCP team is trained to new requirements. | Barker | 2009-04-01 00:00:00 | 2009-04-01 00:00:00
 | 19 | Minor Nonconformance | It is not clear that in all cases verification of pre-requisite programs has been planned and records are available as required. | Question 2 | Plant does not have a defined method of verification of pre-requisites. | Update HACCP plan and ensure HACCP team is trained to new requirements. | Barker | 2009-04-01 00:00:00 | 2009-04-01 00:00:00
 | 20 | Minor Nonconformance | Hand written notes were noted in the HACCP Program for sweetened products, which included changes from a severity rating of “Mild” to “Medium”. There were no initials or dating of the changes and no evidence of HACCP Team review and HACCP Program | Question 3 | HACCP plan had not been reprinted after notes were made to effect some changes. | Update HACCP plan and ensure HACCP team is trained to new requirements. | Barker | 2009-04-01 00:00:00 | 2009-04-01 00:00:00
 | 21 | Minor Nonconformance | A complete, up-to-date written description of raw materials, ingredients and product contact materials is not available as required. | Question 5 | HACCP plan had not been updated to include requirements for descriptions. | Update HACCP plan and ensure HACCP team is trained to new requirements. | Barker | 2009-04-01 00:00:00 | Complete
 | 22 | Minor Nonconformance | The HACCP Programs include in the product description “Products warehoused but not produced”. The contents include juices but not allergens such as dairy that are warehoused. | Question 6 | Plant does not have an allergen procedure and policy. | Create allergen policy and update HACCP plan.  Train all effected associates to allergen plan. | Barker | 2009-04-01 00:00:00 | Complete | Allergen program developed but not referenced in the FS manuals. | Allergen program developed but not referenced in the FS manuals.
 | 23 | Minor Nonconformance | The flow diagram does not clearly describe where re-working, recycling, and residual product waste takes place. There is no evidence of verified flow diagrams. | Question 8 | Flow diagram did not include all required process steps. | Update HACCP plan and ensure HACCP team is trained to new requirements. | Barker | 2009-04-01 00:00:00 | Complete
 | 24 | Minor Nonconformance | There is not evidence that the HACCP team has taken into consideration tampering, sabotage or intentional adulteration as a potential source of hazards. | Question 11 | HACCP plan did not describe where tampering, sabotage or intentional adulteration were considered. | Update HACCP plan and ensure HACCP team is trained to new requirements. | Barker | 2009-04-01 00:00:00 | 2009-04-01 00:00:00
 | 25 | Minor Nonconformance | There is not always evidence that the HACCP team analyzes, reviews and evaluates all the required items as required. There is not evidence that results of the analysis are reported to management review and used as input for updating the HACCP Program. | Question 22 | Management review records did not show evidence where analysis and reviews were documented. | Update HACCP plan and ensure HACCP team is trained to new requirements.  Ensure analysis is included in Management Review. | Barker | 2009-04-01 00:00:00 | 2009-03-27 00:00:00
3.9 Calibration |  |  | 3.9.1 Calibration
 | 26 | Improvement Opportunity | Records of calibrations and verifications in the LDMS calibration database does not provide traceability information (e.g., N.I.S.T.) of the certified reference materials (instruments or standards / calibrants) used for calibration of the equipment. | QMS/EMS/ES/ Standard 3.9    Question 1 | Plant did not have traceability to NIST or lot numbers for calibration standards. | Add NIST or lot number field to the LDMS calibration records | Barker | 2009-03-01 00:00:00 | 2009-01-30 00:00:00
 | 27 | Improvement Opportunity | Certified reference material (such as weight sets) used for calibration of lab equipment is not controlled through the Calibration Matrix or tracked in the LDMS database (to ensure that it is scheduled for recalibration). | QMS/EMS/ES/ Standard 3.9    Question 1 | Plant did not list certified reference materials on the Calibration matrix. | Add Certified reference materials to the calibration matrix. | Barker | 2009-02-01 00:00:00 | 2009-01-09 00:00:00
 | 28 | Improvement Opportunity | No calibration certificate was available for the air monitor (Lumidor Minimax) used by [NAME] for confined space entry. | QMS/EMS/ES/ Standard 3.9    Question 1 | LDMS does not have cells for data entry of the Equipment Maintenance information. | Work with software supplier to add data entry cells for the Equipment Maintenance information. | Barker/Padgett/Fuentes | 2009-02-01 00:00:00 | 2009-03-01 00:00:00 | Software will not be edited to support additional data fields. The air monitor will be moved from the [NAME] list of equipment to the Lab equipment list to capture required data cells.  Projected date 3/1/09. | Software will not be edited to support additional data fields. The air monitor will be moved from the [NAME] list of equipment to the Lab equipment list to capture required data cells.  Projected date 3/1/09.
 | 29 | Improvement Opportunity | The serial numbers were not listed on the Calibration Matrix for the four instruments used by the safety department  (ammonia sensor, ozone sensor, dioxide transmitter, and air monitor) | QMS/EMS/ES/ Standard 3.9    Question 1 | Plant did not list serial numbers for all EOSH equipment. | Add serial numbers to the calibration matrix. | Padgett/Barker | 2009-01-01 00:00:00 | 2009-01-01 00:00:00 | Complete.  Calibration matrix has been edited. | Complete.  Calibration matrix has been edited.
3.10 IMCR |  |  | 3.10.1 IMCR
 | 30 | Improvement Opportunity | A Business Risk Assessment was performed in 2008 and identified five potential “High” risk areas within the risk matrix.  However, only one of the high risk areas had any documentation in the comments section as to the plant’s response to mitigate the risk. | QMS/EMS/ES/ Standard 3.10    Question 1 | No identification of needs assessed. | Added to Business Risk assessment action column. | Durham/McNee | 2009-01-01 00:00:00 | 2008-12-23 00:00:00 | Complete. The business continuity risk assessment will be reviewed during the annual IMCR program review.  An SPC site specific assessment was developed in addition to the corporate version. | Complete. The business continuity risk assessment will be reviewed during the periodic IMCR program review.  An SPC site specific assessment was developed in addition to the corporate version. Change to annual review and add more verbage to risk assessment.
 | 31 | Improvement Opportunity | The plant does not post a key contact list, which includes 24-hour per day phone numbers, and specifies interfaces to the next level up and down within the company system. | QMS/EMS/ES/ Standard 3.10    Question 1 | No controlled copies of phone list posted. | IMCR book, with emergency contacts, will be located at the guard shack and receptionist desk. | McNee, Durham, Vanderhall | 2009-02-01 00:00:00 | 2009-01-01 00:00:00 | Complete. The need for additional distributions of manuals will be determined. EAP contact lists were updated. | Complete. The need for additional distributions of manuals will be determined. The receptionist still had Cloeann on the list.
 | 32 | Improvement Opportunity | The contractor / guard at the truck exit guard shack did not have a copy of the IMCR manual and did not appear to be aware of the IMCR process.  Corrected during the audit. | QMS/EMS/ES/ Standard 3.10    Question 1 | An IMCR manual had not been posted at the truck exit guard shack. | Provide an IMCR manual to the truck exit guard shack and verify understanding of the IMCR process. | McNee, Durham, Vanderhall | 2008-12-04 00:00:00 | 2008-12-04 00:00:00 | Complete. Distributed IMCR manuals will be controlled as off-line documents per the Documentation program. | Complete. Distributed IMCR manuals will be controlled as off-line documents per the Documentation program.
3.12 Audit |  |  | 3.12.1 Internal Audits
 | 33 | Improvement Opportunity | The connection between Corrective Action and Internal Audit is not clearly defined. Audit findings, if significant, may lead to a formal Corrective Action; however “significant” is not defined. The Audit Program states that external audits will be managed within the Corrective Action program. The Continual Improvement Program is not consistent with this statement, allowing for external audit findings possibly to be handled through Corrective Action. | TCCMS 3.12 Question 2 | 1. Continual Improvement program did not clearly define non-conformances identified as "significant" that should be managed through CCBCC's formal Corrective Action system.                        2. Under section 2.3  of the CI program, External Audit is defined as one of the types of "Actions" that can be supported by the CI program.  It also states that actions are determined by the auditee or an assigned team to resolve. | 1. Continual Improvement program's purpose section was edited to clearly define "significant" non-conformances that require a formal Corrective Action method of approach.  2.  Edits were performed to the CI program to remove the statement that actions are determined by the auditee or an assigned team to resolve.  The edits of the CI program clearly defines required actions to perform and under what criteria when addressing external audit non-conformances. | Vanderhall/Hampton | 2009-03-01 00:00:00 | 2009-02-16 00:00:00 | Decision has been made to incorporate Internal and External audit CAPs into the PID section of PHRED.  Audit program will be edited to reflect the changes. | Decision has been made to incorporate Internal and External audit CAPs into the PID section of PHRED.  Audit program will be edited to reflect the changes. The PTOC [NAME] was not added.
 | 34 | Improve. Op. | The Audit Program specifies monthly GMP audits. There is no GMP audit documented for June 2008. The Audit Program does not include a description of how the schedule may be changed and who can change it. There is no evidence of discussion of the audit schedule change in management review. | TCCMS 3.12 Question 2 | 1. Audit program did not state provisions for deviating from the audit schedules.      2. Documented discussions of audit schedule deviations were not in the Management Review meeting minutes. | 1. Audit program was edited to provide provisions for deviating from the established audit schedule. This included those authorized to approve deviations from the audit schedule when required.                       2.  In the event deviations from the audit schedule occur, document justifications and plans to conduct audit by lead auditor in the Management Review meeting minutes. | Vanderhall | 2009-03-01 00:00:00 | 2009-02-16 00:00:00 | Edits have been made to programs.  New program owners need to be trained to edits and programs routed in Livelink for control. | Edits have been made to programs.  New program owners need to be trained to edits and programs routed in Livelink for control.
 | 35 | Improvement Opportunity | There is not always evidence of verification activities as required by the standard.  The Audit of Audits performed in 8/08 is closed although the report does not include verification. Review of several audits indicated some findings were closed with verification information noted as “Complete”. | TCCMS 3.12 Question 2 | Lead auditors are not completing the audit reports consistently and completely for all types of audits. | Perform refresher lead auditor training and emphasize the importance of completing audit reports properly. | Vanderhall/Law | 2009-02-01 00:00:00 | 2009-01-16 00:00:00 | Discussions with Lead auditors have occurred to address audit reporting / practices deficiencies. | Discussions with Lead auditors have occurred to address audit reporting / practices deficiencies.
 | 36 | Improvement Opportunity | Not all audit forms are being completed: e.g., “Date of Review”, and “Reviewed with These Management Representatives” is not completed on 2 of 3 audits reviewed. | TCCMS 3.12 Question 2 | Lead auditors are not completing the audit reports consistently and completely for all types of audits. | Perform refresher lead auditor training and emphasize the importance of completing audit reports properly. | Vanderhall/Barker/Fuentes/Padgett | 2009-02-01 00:00:00 | 2009-01-16 00:00:00 | Discussions with Lead auditors have occurred to address audit reporting / practices deficiencies. | Discussions with Lead auditors have occurred to address audit reporting / practices deficiencies.
 | 37 | Improvement Opportunity | Some environmental audits are on file and findings documented as closed, indicating they had been corrected; however the corrective action is not dated. | TCCMS 3.12 Question 2 | Lead auditors are not completing the audit reports consistently and completely for all types of audits. | Perform refresher lead auditor training and emphasize the importance of completing audit reports properly. | Vanderhall/Barker/Fuentes/Padgett | 2009-02-01 00:00:00 | 2009-01-16 00:00:00 | Discussions with Lead auditors have occurred to address audit reporting / practices deficiencies. | Discussions with Lead auditors have occurred to address audit reporting / practices deficiencies.
3.14 Continual Improvement |  |  | 3.14.1 Continual Improvement
 | 38 | Improvement Opportunity | The criteria for determining what deviations require corrective action is not clearly defined. E.g. “Significant” is used but not defined. | TCCMS 3.14 Question 1, 3 | Continual Improvement program does not provide a clear definition of what is "significant" and therefore needs to managed through the program's formal Corrective Action Request (CAR) process via the PHRED system. | Edit the Continual Improvement program to clearly define what is "significant" and therefore requires the formal CAR process. | Hampton/Vanderhall | 2009-03-01 00:00:00 | 2009-02-26 00:00:00 | Edits to program have occurred.  Needs to be controlled in LL. | Edits to program have occurred.  Needs to be controlled in LL.
 | 39 | Improvement Opportunity | It is not always clear that verification has occurred or what the verification entailed. | TCCMS 3.14 Question 1, 3 | Verification steps for identified continual improvement (CAR) efforts were not properly documented. | Retrain to the PHRED CAR system to ensure that all users understand requirements associated with the verification stage.  Investigate incorporate all action plans from audits in the Problem Identification (PID) section of PHRED. | Hampton/Vanderhall | 2009-03-01 00:00:00 | 2009-04-03 00:00:00 | RCA training has been provided for management team, supervisors, and leads.
 | 40 | Improvement Opportunity | The Continual Improvement Program does not address all aspects of continual improvement/corrective action in place at the plant. For example: additional practices include action items and action plans for management review meetings and GMP tracking. | TCCMS 3.14 Question 1, 3 | The Continual Improvement program does not address action items out side of those derived from audits. | Edit the Continual Improvement program to address how other action decks are managed. | Hampton/Vanderhall | 2009-03-01 00:00:00 | 2009-02-26 00:00:00 | Edits have been made to the CI program to reflect the multiple sources of action plans.