Toller UPL Quality Audit Checklist V2

• Site conducted

• Conducted on

  Date

• Prepared by

• Location

1.1 Management and documentation

• 1.What is the certification status of the company?

  Yes

  No

  N/A

• 2. Is the management system described in full in a management manual?

  Yes

  No

  N/A

• 3.Are Q, S, E, others.. management systems integrated or described separately?

  Yes

  No

  N/A

• 4.Does the documentation cover all levels of the document hierarchy (processes, procedures, specifications, certificates, etc.)?

  Yes

  No

  N/A

• 5.Are the company Processes presented in a form that enables the mutual dependencies and process responsibilities to be identified (e.g. process model, process mapping)?

  Yes

  No

  N/A

• 6. Is the documentation system appropriately communicated and readely accessible (eg IT solutions)?

  Yes

  No

  N/A

1.2 Control and traceability of documents, data and records

• 8.Are appropriate users notified when new documents are issued or existing documents are updated?

  Yes

  No

  N/A

• 9.Are these documents & data available at the right places?

  Yes

  No

  N/A

• 10.Are these documents & data listed (hard / e-) and reviewed?

  Yes

  No

  N/A

• 11.Are there procedures to establish and maintain identification, collection, accessibility, indexing, filling, storage place & time, maintenance and disposition of records, including training, audit, reviews, problems, compliance certificates (MSDS,) and pertinent sub-contractor records, incl records related to Quality ?

  Yes

  No

  N/A

• 12.Are computorised records backed up and stored off site or in a secure environment. Paper records are maintained in a secure environment to prevent loss, damage, deterioration and confidentiality?

  Yes

  No

  N/A

• 13.Are the raw materials, tools, machines, processing aids, SFG and FG identified appropriately throughout the production process?

  Yes

  No

  N/A

• 14.Are processing aids and hazardous materials recorded appropriately?

  Yes

  No

  N/A

• 15.Provided a finished product lot number (given by the auditor), what product identification and traceability information can you provide on raw material lot identification (to what level can raw material components be traced, production process information (tools,...), production equipment used, manufacturing sequence, finished product test results, and shipment information? Approximately how long does it take to provide all these informations?

• 16.What is the level of detail of traceability (raw materials, tools, FG)?

• 17. How is the identity and traceability of reworked product/repaired tool maintained?

2. Management responsability

2.1 Management commitment

• 18. Is the development/introduction of the management system a strategic decision of the company management? (i.e. policies, MBO, budget, strategic plan...)

  Yes

  No

  N/A

2.2 Company policies

• 19.Does the company have written policies for Quality ?

  Yes

  No

  N/A

• 20.Are the policies consistent with UPL policies?

  Yes

  No

  N/A

• 21.Are the policies customer oriented?

  Yes

  No

  N/A

• 22. Do they include : -a commitment to continual improvement, - prevention of accidents -a commitment to comply with the law, local authority regulations and other contractual or market requirements?

  Yes

  No

  N/A

• 23.Are the policies endorsed by top management ?

  Yes

  No

  N/A

• 24.Are policies regularly reviewed in terms of their suitability and effectiveness?

  Yes

  No

  N/A

• 25. To what extend is the work force involved in the policy and decision making process?

• 26.Are business sustainability and social responsibility taken into account when the organisation defines and/or updates the policies?

  Yes

  No

  N/A

• 27.Are the policies accessible to interested parties and communicated to all employees so that it is understood and familiar at all levels of the organization?

  Yes

  No

  N/A

2.3 Planning

2.3.1 Identifying hazards, risk assessment and risk control (aspects+risk management)

• 28. Is there a method for risk assessment?

  Yes

  No

  N/A

• 29. Is the method is in line with UPL method?

  Yes

  No

  N/A

• .Are risks associated with identified hazards determined by:

• 36.Are identified hazards prioritised according to their risk?

  Yes

  No

  N/A

• 37. Is suitable and qualified consulting expertise engaged when specialised skill is required to identify hazards and assess risks?

  Yes

  No

  N/A

• 41.Has the company carried out a preliminary quality risk assessment?

  Select Yes No N/A

  • Yes
  • No
  • N/A

• 42.Has risk assessment identified all necessary Critical Control Point's?

  Yes

  No

  N/A

• 43. Is there a crisis management plan (emergency plan, contingency plan, crisis communication) which includes quality risk?

  Yes

  No

  N/A

2.3.2 Legal and other requirements

• 46. How can the company demonstrate knowledge of and accountability for, applicable regulations, company standards and customer's contracts, to which they are subject?

• 47. Is there a procedure for recording, maintaining and communicating (to appropriate users) regulations and legal & contractual requirements ?

  Yes

  No

  N/A

• 48.Are there any indications that the supplier is in compliance with established national and local regulations or with contractual specifications?

  Yes

  No

  N/A

• 49.Has the company never been cited for non-compliance with any regulations or contract? If no, when and for what ?

  Yes

  No

  N/A

• 51.Are responsibilities and competences for Regulatory Affairs (regulation watch, compliance check and certification) and PI defined?

  Yes

  No

  N/A

• 52. Is there an inventory of materials subject to regulations or contractual requirements?

  Yes

  No

  N/A

2.3.3 Objectives & targets

• 53. To what extend do measurable goals exist against which progress can be tracked (KPI's, programmes, objectives)? Try to assess the relevance and level of challenge in any programmes.

• 54. Is there a process for continuous setting and review of objectives of each individual level (i.e. KPI, MBO)?

  Yes

  No

  N/A

2.3.4 Quality program

• 55. Do programme(s) exist and are they current and enforced?

  Yes

  No

  N/A

• 56. Do these programme(s) specify the required activities and resources with specific responsibilities, the means and the time schedules in order to achieve objectives and targets?

  Yes

  No

  N/A

• 57.Are all hierarchy levels and the relevant functions included?

  Yes

  No

  N/A

• 58.Are the programs systematically reviewed and updated at planned intervals?

  Yes

  No

  N/A

• 59.Are the programs adapted to suit the changes that may occur in the activities, products, services or working conditions of the organisation?

  Yes

  No

  N/A

• 60.Are the applicable objectives integrated in the program(s)?

  Yes

  No

  N/A

2.4 Responsabilities, roles

• 61. How well does the organisational structure define quality responsabilities and authorities?

• 62.Clear organisational charts and job accountabilities are defined. Back-up personnel are appointed for key positions.

  Yes

  No

  N/A

• 63.Quality responsible has been appointed and is a member of the Company Management?

  Yes

  No

  N/A

• 64.Quality responsible has competence and authority to implement the system(s) and report on it?

  Yes

  No

  N/A

• 65. Do these procedures provide the availability of appropriate instruments for top-down communication and vice versa as well as for any communication with third parties affected/concerned ?

  Yes

  No

  N/A

• 66.Are changes in the activities and related effects communicated to the interested parties?

  Yes

  No

  N/A

• 67.- included within the development and review of the risk management policy and procedure,

  Yes

  No

  N/A

• 71. Is external feedback systematically evaluated and used to improve the process?

  Yes

  No

  N/A

2.6 Measurement, monitoring, analysis (statistical method)

2.6.1 KPI, PPI

• 74.Are there measures (KPIs) utilized to assess performance and drive process improvements.

  Yes

  No

  N/A

• 75.Costs of the Quality system are known (Prevention, Appraisal, Failures)?

• 76. Is there a process for describing the procedures on how data is collected and analyzed?<br>.Is the scope of the data collection and analysis sufficient to:

  Yes

  No

  N/A

• 77.- ascertain the system effectiveness,

  Yes

  No

  N/A

• 78.- ascertain process reliability and suitability,

  Yes

  No

  N/A

• 80.- ascertain agreement with the legal and stakeholders requirements,

  Yes

  No

  N/A

• 81.- ascertain all processes and product/service compliance,

  Yes

  No

  N/A

• 82.- evaluate suppliers?

  Yes

  No

  N/A

• 83.Does the system identify the critical success factors of the realization processes, which influence the fulfilment of the requirements for product/services (CCP) ?

  Yes

  No

  N/A

• 84.Are the procedures appropriate for monitoring Quality Incident?

  Yes

  No

  N/A

• 85. Is there evidence that these KPI's are reviewed by the management on a regular basis?

  Yes

  No

  N/A

2.6.2 Audits (internal, external)

• 86.Have internal audits been conducted?

  Yes

  No

  N/A

• 87.Are audits conducted according to the any reference standard?

  Yes

  No

  N/A

• 88.Describe your process for conducting internal/external audits (planning, scheduling, frequency, etc.)

• 89.Are the audit intervals appropriate and are the audit results taken into account when producing the program?

  Yes

  No

  N/A

• 90.The company has a program to audit affiliates/sister companies

  Yes

  No

  N/A

• 91.Are the auditors sufficiently qualified and independent?

  Yes

  No

  N/A

• 92.Has the company been audited by customers?

  Yes

  No

  N/A

• 93.Are the findings that are made during the course of the audit recorded and the competent personnel responsible informed accordingly?

  Yes

  No

  N/A

• 94.Are the required corrective actions done, reviewed, checked on effectiveness and documented on the basis of the audit results?

  Yes

  No

  N/A

• 95.Are the findings and actions communicated across the group/organisation ?

  Yes

  No

  N/A

• 96.Does the company have a program to audit suppliers?

  Yes

  No

  N/A

• 97. Are audits conducted according to the planning?

  Yes

  No

  N/A

2.7 Management review

• 98.Are the management systems, strategic plan, policies, programs and objectives reviewed periodicaly?

  Yes

  No

  N/A

• 99. Is there a documented review of the outcome of audits, client satisfaction, client complaints, employee satisfaction, product/service quality, non-conformance costs, CCP, adherence to requirements in respect of environment, safety and legislation as well as the evaluation of the financial results and the status of the improvement measures?

  Yes

  No

  N/A

• 100. Is a process for continuous improvement in the management system and the company's performance defined and implemented?

  Yes

  No

  N/A

• 101.Does the management review lead to an improvement program?

  Yes

  No

  N/A

2.8 Preventive & corrective actions, improvement

• 102.Are there processes or tools to prevent incidents, nonconforming products, equipments, services?

  Yes

  No

  N/A

• 103.What type of analysis is performed on records and customer/stakeholders complaints? (e.g. Pareto charts, trend analysis, control charts, Ishikawa, FMEA...)?

• 104. Is there monitoring of preventive and corrective actions?

  Yes

  No

  N/A

• 105.Are all the inputs taken into consideration (audits, complains, incidents, alerts, near misses, ...)?

  Yes

  No

  N/A

• 106. How is the effectiveness of corrective action evaluated?

• 107.Are all corrective actions from last UPL audit corrected as per time frame agreed on last audit corrective action plan?

  Yes

  No

  N/A

• 108. Is there a process to prevent the immediate (prior to risk analysis) recurrence of an incident or non-conformity?

  Yes

  No

  N/A

3. Resources

3.1 Resources availability

• 109.Does the management provide the necessary resources for the implementation, control of and improvement in the management systems?

  Yes

  No

  N/A

3.2 Support Processes

3.2.1 Human Ressources

• 110.Are job descriptions available for all relevant roles

  Yes

  No

  N/A

• 111.Are job descriptions reviewed when necessary (procedure exists, documented evidence)

  Yes

  No

  N/A

• 112.Job description contains necessary competences and skills (professional (and related regulations), Quality, aspects are considered and adapted to each role of the organisation)

  Yes

  No

  N/A

• 114.Are assigned personnel competent on the basis of training, skills or experience?

  Yes

  No

  N/A

• 115.Induction programs are established systematically ("role change", refreshing sessions (frequency?), deputies, temporary employees & contractors as well)

  Yes

  No

  N/A

• 116.There is a system for training needs evaluation

  Yes

  No

  N/A

• 117.There is a system to measure employee satisfaction

  Yes

  No

  N/A

• 120.Does the training ensure that all employees are aware of existing or potential consequences for their work activity in the event of failure to comply with the instructions,

  Yes

  No

  N/A

• 121.Deputies, back-ups and succession plans are established

  Yes

  No

  N/A

• 122. Is the training properly documented (docs signed by both parties and records are maintained as necessary e.g. on Quality topics)

  Yes

  No

  N/A

• 123. Is the training adapted to all employees (language, method, visuals,...)

  Yes

  No

  N/A

• 124. Training needs, performed, effectiveness and objectives are reviewed on a regular basis

  Yes

  No

  N/A

• 125.Does the company evaluate the effectiveness of training?

  Yes

  No

  N/A

3.2.2 Technical support (infrastructure)

• 127.The machinary, equipment, infrastructure show a suitable state of condition that will not adversely impact product quality, employee OHS or the environment.

  Yes

  No

  N/A

• 128. Are there inspection, cleaning, and sanitizing procedures? (for raw and in-process material storage vessels and containers, processing equipment, and material delivery systems to include pumps, conveyors, hoses, discharge lines, containers, and vehicles)

  Yes

  No

  N/A

• 129. How adequate are storage areas and facilities?

• 130.Have any requirements for laboratory environmental conditions been determined for impact on measuring equipment? How are these conditions monitored and controlled?

  Yes

  No

  N/A

• 131. Is a preventive equipment maintenance program in place?

  Yes

  No

  N/A

• 132. To what extend does the supplier document tool wear and utilise it in preventive maintenance?

• 133. Is there management of spare parts (critical ones) ?

  Yes

  No

  N/A

3.2.3 Quality, Safety, and Environment

• 134.Are Safe/Standard Operating Practices (related to QUALITY) available at the working place?

  Yes

  No

  N/A

• 135.Are Inspection frequency and size established on the bases of process capability and/or risk assessment (supplier recommendations, regulations, norms, customer specifications)?

  Yes

  No

  N/A

.3.2.4 Finance and Controlling

.3.2.5 IT

• 142.Does the company have an appropriate data and information management (hardware, software)?

  Yes

  No

  N/A

• 143.Does the company have for IT an appropriate crisis management plan and backups ?

  Yes

  No

  N/A

• 144.Does the company have a clear policy for data security (access rights, employees, contractors, temporary work, frirewalls, hackers) ?

  Yes

  No

  N/A

• 145.Does the company follow UPL Standards ?

  Yes

  No

  N/A

4 Implementation and operation

.4.1 Operational control

4.1.1 Sales

• 154. How is the client notified if contractual agreement can not be met.

4.1.2 Product development

• 167.Are there any restrictive patent or agreement ?

  Yes

  No

  N/A

• 168.Are all Q, aspects considered at the development stage (incl. Raw materials, waste, disposal, obsolete tools) ?

  Yes

  No

  N/A

• 169. Is the client informed about potential restrictions/limitations in the usage of the good or service due to the development stage?

  Yes

  No

  N/A

• 170. Is design/development verification carried out to check and document whether the requirements have been met?

  Yes

  No

  N/A

• 171. Is the know-how stored appropriately after the design and development project has been terminated/completed?

  Yes

  No

  N/A

4.1.3 Production & Logistique

Planning

Procurement

• 173. Do purchasing documents specify clearly the product or refer to a detailled specification sheet?

  Yes

  No

  N/A

• 174. Do purchasing specs define clearly quality, quantity, timing, purity, and regulatory requirements?

  Yes

  No

  N/A

• 175.Are suppliers periodicaly evaluated, audited and do they get feedback?

  Yes

  No

  N/A

• 176.Are alternative/backup raw materials, tools and suppliers submitted for approval for Quality?

  Yes

  No

  N/A

Reception

• 177. How are incoming materials received (tanker, rail car)? Are incoming raw material carriers dedicated to specific products? Describe raw material carrier inspection procedures. Are inspection procedures documented?

  Yes

  No

  N/A

• 178. How do you determine that incoming materials conform to specifications (COA, sensory evaluations, standard physical and analytical analysis, compositional analysis, and microbiological analysis)?

  Yes

  No

  N/A

• 179.Are COA's, supplier test data and/or your incoming test data evaluated against product specifications? Describe the process of reviewing COA's. When discrepancies are found between COA's, incoming inspection, and specifications, describe the steps taken for resolution?

  Yes

  No

  N/A

• 180.Are material audits conducts to verify conformance to COA's? What is the frequency of these audits?

  Yes

  No

  N/A

Manufacturing

• 193.Are the employees aware of the competencies and methods of approach to rectifying the deviations?

  Yes

  No

  N/A

• 195.Are inspection records kept?

  Yes

  No

  N/A

• 196.What test data or COA is currently provided to UPL?

• 197.Can all or a part of the manufacturing be subcontracted ? If yes, what are the checks ?

  Yes

  No

  N/A

• 199. How do you verify that only approved products/services are shipped/delivered?

• 200.Are responsibilities for status verification clearly defined?

  Yes

  No

  N/A

Storage Distribution

• 202.The infrastructure and transportation means show a suitable state of condition that will not adversely impact product quality, employee OHS or the environment.

  Yes

  No

  N/A

4.2 Operational support

4.2.1 Control of testing and measuring devices

• 204.Are all test materials and equipments systematically monitored, calibrated and maintained on a regular basis ?

  Yes

  No

  N/A

• 206. Is the verification of the test material and equipment based on acknowledged national or international standards? Otherwise, the basis used for calibration shall be recorded.

  Yes

  No

  N/A

• 207.Who is responsible for performing calibrations and maintenance of inspection, measuring, on-line control and test equipment? Is this person properly trained?

  Yes

  No

  N/A

• 208. How are calibration records maintained?

  Yes

  No

  N/A

• 209. How is calibration status identified for equipments or instruments?

  Yes

  No

  N/A

• 210.When equipment is found out of calibration, is the validity of previous inspection assessed and documented?

  Yes

  No

  N/A

• 211. Is the equipment identified accordingly?

  Yes

  No

  N/A

• 212.What are the backup solutions when an equipment is out of calibration/service?

  Yes

  No

  N/A

• 213.Are all inspections and test methods carried out according to defined procedures and methods? Are results compared to specification for identifying nonconforming products?

  Yes

  No

  N/A

• 214. How comprehensively are analytical methods documented and applied?

  Yes

  No

  N/A

• 215. Do you perform routine calibration checks with working standards between scheduled calibrations? Are these checks documented?

  Yes

  No

  N/A

• 216.Have any requirements for laboratory environmental conditions been determined for impact on measuring equipment? How are these conditions monitored and controlled?

  Yes

  No

  N/A

4.2.2 Treatment of non conformity, complaints & accidents

Raw materials, tools,services

• 217.Are there defined procedures which stipulate the responsibility and authority regarding the handling and analysis of accidents, incidents, non-compliance (non-conformities) and the introduction of corrective and preventative measures?

  Yes

  No

  N/A

• 218.Are appropriate measures initiated in the event of non-conformities being discovered following delivery/commissioning of the products/services (incl. recall process as required)?

  Yes

  No

  N/A

• 219.Is there a system for reporting non-conformance, which ensures that the competent departments are informed of the type and extent of non-conforming products and take the necessary decisions?

  Yes

  No

  N/A

• 220.Are corrective actions followed? Is effectiveness of actions undertaken checked?

  Yes

  No

  N/A

• 221.Is there a process for the control of non-conforming products/services defined and implemented?

  Yes

  No

  N/A

• 222.Are non-conforming products/services identified as such and picked out?

  Yes

  No

  N/A

• 223.Do you have a segregated nonconforming holding area? If so, summarize how nonconforming materials are inventoried and reconciled.

• 224.How do you verify that reworked product conforms to specifications?

• 225.Have you had any products or raw material recalls?

  Yes

  No

  N/A