Procedure MQC/SP/004
| Conduct of Audit |
| 1 Opening Meeting |
| An opening meeting between the client’s representatives and the assessment team takes place before the assessment starts |
| The Team Leader at this meeting ensures: |
| a record of the meeting is made and any significant discussion points are recorded |
| the client’s representatives and the assessors are all introduced. The Attendance Sheet shall be used to record those present during opening & closing meetings. |
| the proposed scope for which registration is sought is confirmed, any activities that are to be excluded from the assessment are also confirmed at this stage |
| the issue status of the firms documented quality system is confirmed |
| a representative of the client is available to accompany each assessor. The role of the representative should be explained |
| that office facilities are available, and confirms normal working hours, lunch arrangements etc. |
| Any Health and Safety hazards are identified and adequate protection is available |
| The Team Leader gives an explanation of how the assessment will take place including: |
| Confirming the documents which define the requirements e.g. relevant Standard, MERIT QUALITY CERTIFICATION’s Contract Terms & Schemes for Registration |
| Confidentiality Statement signed by the Team Leader and Team Members (If any) and given to the client |
| defining the content of the assessment schedule and ensuring key company personnel are available |
| confirming the assessment schedule to the client identifying each assessor’s responsibilities |
| Intermediate daily meetings |
| Closing meeting |
| Explaining that the assessment process is based on sampling |
| Describing the method of reporting non-conformities and categorizing them |
| Explain possible outcomes / recommendations |
| Explaining that if a major nonconformity is identified the Supplementary/ Re-assessment may be required |
| The client’s representatives are invited to ask questions |
|
2 Task Allocation |
| Task allocation is necessary to establish and confirm the assessment programme prior to or as an integral part of the Introductory meeting. |
| The Team Leader may ask if the team can be taken on a quick tour to become familiar with the size and geography of the site. This is particularly useful if the site is large or has not been visited before. |
| The Team Leader then holds a short briefing meeting with the assessment team to confirm: |
| they are fully aware of their individual responsibilities |
| the area allocated to each team member for assessment |
| they are familiar with the structure of the client’s documented quality system. |
| 3 Assessment |
| On a sampling basis each assessor (accompanied by a client’s representative) audits the system in their allotted area. |
| Each assessor maintains a legible and positive assessment trail, using the assessment detail report forms. The names |
| of client staff interviewed, locations, identities of relevant drawings, documents, data, procedures, observations and nonconformities |
| are recorded. The relevant clause of the standard is also recorded within the left-hand margin of the form. |
| Recording on forms an essential part of the final assessment report and provides a comprehensive cross-reference. |
| The Team Leader ensures that the assessment takes account of all requirements of the management standard. The Team |
| Leader is responsible for ensuring that each assessor supplies the required information and that the progress is regularly |
| reviewed during the assessment. Assessors should particularly note points, which require data from, or for, other assessors. |
| The team leader specifically ensures the assessment of internal Audit, Management Review, Corrective Action & Preventive |
| Action is done to ensure an effective management system being operated. |
| All reports, including the assessment detail report, are to be legible and in a language understood by the certification |
| authority who reviews the report. |
| 4 Nonconformity Reporting |
| Non-conformities are recorded within the body of the final assessment report. Only objective evidence of system, service or |
| product non-conformities is recorded, this includes non-conformities issued against the client’s documented procedures. |
| Observations and any opportunity for further improvements are also recorded. |
| Apparent non-conformities shall be discussed at the time of discovery with the client’s representative since they may be able |
| to give clarification, or may know where other information can be found. Each assessor shall be objective and open-minded |
| when judging conformity and shall never make decisions based on preconceived ideas or familiar practice. |
| Where an apparent (previously identified) nonconformity has subsequently been found to be invalid, then the reason for this |
| is documented. |
| Apparent major non-conformities are referred to the Team Leader in order to initiate the early warning. |
| Each non-conformity includes: |
| the management standard clause number, Quality Assessment Schedule (where relevant), quality plan, regulation, etc. |
| against which the nonconformity is issued |
| the company documentation reference, where appropriate |
| where the nonconformity was observed (e.g. incoming control) |
| the details of the nonconformity |
| the identification of documents or items involved |
| the nonconformity reference number comprising the assessors initials and a sequential number starting at 1. Each |
| assessor’s non-conformities are sequentially numbered from 1 |
| The nonconformity, worded in the same language as the requirement, indicates the observation which failed to meet the requirement. |
| 5 Notifying Major nonconformity to the client |
| If a major nonconformity is raised the Team Leader shall notify the client that the recommendation will be not to certify and |
| that a further assessment will be required. The Team Leader advises the client of this notification in the closing meeting |
|
6 Daily Intermediate Meetings |
| Where the assessment lasts for more than one day, the assessment team meet to review findings and progress at the end of |
| each day. |
| Following this, a review meeting is held with the client. |
| At this meeting the following topics are covered: |
| progress of the assessment |
| the number and category of any non-conformities raised |
| any areas where it seems likely that non-conformities will be raised |
| any difficulties in obtaining the required information |
| any difficulties advised by the client because of the way in which the assessment is being carried out |
| any other problems which could emerge |
| 7 Preparing Recommendations |
| When each assessor has completed his allotted task, the assessment team will meet, with the Team Leader as chairman. |
| The objectives are to: |
| Check that all aspects of the planned assessment have been completed |
| Obtain all team members’ views on what they have assessed |
| Categorise each observed nonconformity |
| Consider whether there are any patterns of related non-conformities |
| Draw an audit conclusion and record it. |
| Decide upon the team’s recommendation |
| The assessment team reaches its recommendation by consensus. If they are unable to reach consensus, the Team Leader |
| makes the final decision. The Team Leader is responsible for recording in the report that the decision was not reached by |
| consensus. |
| After this meeting, the Team Leader prepares the assessment report that contains the team recommendation and a statement of the situation found by the assessors based on the observed non-conformities. The report highlights particular areas that require corrective action but does not advise the client on how to correct non-conformities. |
| 8 Guidelines for Recommendations |
| Categorisation of non-conformities: |
| Nonconformity: a situation where there is a likelihood that non-conforming product or service will occur, or where the benefits |
| of the management standard are not being realised, because of the absence of, or lack of adherence to a procedure. |
| Major nonconformity: a nonconformity or a number of non-conformities which together are of such severity that its existence |
| would indicate that non-conforming product or service could be released to the customer or where the requirements of an |
| appropriate clause of the Management Standard has not been adequately addressed. |
| Some procedures may be newly implemented and operational evidence limited. Some objective evidence on implementation |
| must be found, as merely documenting procedures is insufficient. If there is only limited objective evidence the immaturity of |
| the system is reported and followed up with checks during Surveillance Assessment visits . |
| 9 Recommendations |
| Possible recommendations are: |
| Recommend certification, this is permissible: |
| Where no non-conformities and no doubts exist. |
| Where a number of non-conformities exist which together do not indicate a major failure of the client’s quality system, |
| provided that the submission date of a Corrective Action Programme is agreed with the client management |
| representatives. |
| Recommend further assessment, this is permissible: |
| Where a major non-conformity or a number of non-conformities exist which accumulate to form a major nonconformity |
| of the client’s quality system. |
| The Team Leader should discuss future action with the client and explain that the client will have to demonstrate that |
| satisfactory corrective action has been implemented to overcome the non-conformities and prevent reoccurrence. (See item |
| 14 below) |
| Agreement on the date by which the programme for corrective action will be submitted is confirmed, as appropriate. This |
| programme will detail the target implementation dates of the corrective action for each nonconformity and provide details of |
| the investigation, analysis preventative action and controls applied. |
| Team Leader is required to specifically mention that in the event of a Non-successful Supplementary Assessment or a Supplementary Assessment not arranged with in 6 months |
| period will lead to the repeat of full Registration Assessment. |
| 11 Presentation to the Client |
| The purpose of the closing meeting is to inform the client of the team’s recommendations and to present to them any nonconformities |
| raised. |
| a record of the meeting is made and any significant discussion points are recorded, |
| The sequence of the presentation is at the Team Leader’s discretion but includes, as appropriate: |
| Thanking the client for their hospitality and for their assistance and co-operation |
| A resume of the agreed scope of the assessment and the reference documents |
| Issue date 01 Aug 2009 Approved By Chief Executive |
| A presentation of the areas covered and non-conformities found by each assessor. This may be in the form of a summary where appropriate |
| Ensure signatures have been obtained for the report to acknowledge receipt and understanding |
| When necessary, observations and any opportunity for future improvement on particular activities of the client that will |
| also be included in the assessment report |
| An overall summary and conclusion which will make the point that the assessment was conducted by sampling, so |
| that non-conformities may exist even when not observed |
| An invitation to the client to discuss specific points |
| The recommendation on Certification and Surveillance Assessment, emphasising that the team’s recommendation is |
| subject to confirmation |
| Advise the client of the Appeals procedure when certification has not been recommended and the client is in dispute |
| with the teams recommendation |
| Agreement on the date by which a corrective action plan will be submitted providing detail of the investigation, |
| analysis, preventative action and time scales for resolution of each nonconformity recorded |
| When certification is recommended: |
| Explain the evaluation of the corrective action programme and that certificate issue may be delayed until some or all |
| of the non-conformities have been corrected. |
| Explain the Surveillance Assessment process including the Reassessment requirements . |
| Explain that any future significant changes to the quality manual must be brought to the attention of MERIT QUALITY CERTIFICATION. |
| Explain the extent to which the MERIT QUALITY CERTIFICATION reports may be made available to customers to maximise the benefits of certification. |
| Explain briefly how the logos may be used. |
| Small Business |
| In case the client being a very small enterprise( strength less than or equal to 5), the registration assessment is completed |
| within one day and covers the whole system. Re-assessment for recertification is conducted once in three years |
| Obtain the signature of the Client’s Representative to acknowledge receipt of the report. |
| The client is advised accordingly to keep all records of assessments and corrective actions for review by assessment |
| personnel whenever required |
| 12 Distributing Report |
| Responsibility – Team Leader |
| The report copies are distributed as follows: |
| The first copy of assessment report is handed over to client |
| The Second copy of assessment report is forwarded to the Manager (Assessments) as part of the |
| assessment pack including any other informatory material taken during assessment such as Product Catalogue etc. |
| 13 Planning |
| Following a successful recommendation for Certification, the team leader produces an outline plan for the |
| assessment cycle. |
| The forward plan should identify the organisational units to be assessed. Additionally, a detailed plan for the first |
| Surveillance assessment is prepared on a Form No:- |
| The plans should form part of the assessment pack submitted for Certification Review. |
| 14 Further Assessment |
| Reassessment |
| The assessment is conducted in accordance with this procedure. |
| The scope of the assessment as a minimum, reviews the progress made against each of the non-conformities raised |
| during the initial assessment. The implementation of effective corrective action in relation to the Major Nonconformities |
| should be confirmed. If the Corrective Action has not been implemented or is not seen to be effective, or |
| further Major Non-conformities are realised, then another recommendation for further assessment is made. |
| 15 Records |
| All documentation is archived in the Client file, procedure |
| refers. |
| TITLE: SURVEILLANCE ASSESSMENT |
| Introduction |
| This procedure defines the responsibilities and authorities for conducting surveillance assessment visits. |
| These include: |
| all activities following the issue of the certificate |
| initiation and completion of surveillance assessment visits |
| processing and distribution of reports |
| Surveillance assessment is the process employed to ensure that the compliance to the |
| standard established at the registration assessment is maintained and to collect sufficient, verifiable information to justify and record any adjustments to the Surveillance / Re – Assessment Programme |
| Purpose |
| The purpose of this procedure is to ensure that: |
| the client’s documented system continues to meet the requirements of the specification |
| and the scope of registration |
| this system is followed in practice |
| the client remains fit to hold MQC certificate of Registration. |
| 1 Surveillance Assessments & Teams |
| The CE or delegate schedules the visit(s) on a specified date, informs the Client in advance and confirms through the Assessor Allocation / Intimation letter / mail. The assessor allocation is done as per the Procedure of Assessment Preparation |
| First Notice to inform the due dates to client are released 3 / 2 months in advance to the actual due date. |
| (The actual due date is 6 months from the date of |
| Registration assessment or 12 months depending upon the cycle being 6 monthly or annually resp. In case). |
| Second Notice or a follow up call (calls) is arranged appx. I month before the due date. |
| In case if the date is not agreed till 7 days before the due date , a Notice indicating a suspension warning is released. |
| In case if the due date is approached and the date is still not agreed or not responded from client , with in 7 days after the due date the Client’s Registration is Suspended with intimation to suspend the use of Registration Status. |
| Suspension period may vary 1 to 3 months depending upon the circumstances and may be extended to 6 months only by CE in exceptional cases. |
| In case if the attempts failed to conduct the Surveillance Assessment with in Suspension period , the Registration is Withdrawn. |
| Client is notified of the all communications time to time. |
| A fresh certification cycle may be started if any Full Re assessment is done prematurely based on circumstances. |
| CE or delegated Surveillance coordinator agrees the dates and assign the Assessment with approval from CE |
| . At all time during the cycle the |
| original RA Report is considered. |
| Concerned assessor releases the Audit Plan in advance to the visit for client’s confirmation thru the MERIT QUALITY CERTIFICATION Office ( Surveillance) Coordinator. |
