ASC Multi-Site Certification Proposal Overview

Transcription

1 ASC Multi-Site Certification Proposal Overview Multi-site certification is designed for clients that own or have full operational control of up to 50 production sites and wish to have them all certified under a single certificate. Some producers prefer this approach because it is aligned with how their operation is run: as a single operation that has a number of production sites under central control that all follow the same operational procedures. This proposal is designed to achieve the following objectives: Ensure that ASC multi-site certificates achieve the same level of assurance as ASC single site certificates do; Reduce the cost of certification for multi-site operations over having each site individually certified; and Ensure ongoing monitoring of all certified sites by the client, which is then audited by the CAB. In this proposed Multi-site Certification methodology, all the sites included in the scope of certification are considered as one unit of certification. In the same way that any non-conformities found at any site during an audit, are to be closed as part of the responsibility of the multi-site management operation. ASC multi-site certification is designed to be used by operations that operate multiple sites using the same operating procedures for all sites and have a professionally managed and well-developed system to ensure that each site, as well as the central office, consistently meet or exceed performance objectives set in the ASC standards. This proposed ASC multi-site certification proposal includes five elements: 1. This overview document 2. Revisions to the ASC CAR that set the conditions that multi-site clients must meet. 3. A new Annex E to the CAR that sets the additional requirements that a CAB must follow in auditing a multi-site operation. 4. The ASC multi-site sample size combined calculator 5. Revised ASC audit report template that includes additional elements to be included for reports on multi-site audits. It is a work in progress. ASC intents to review this methodology after two years and improve it, as required. March 2017 Page 1 of 5

2 How does a multi-site operation get audited and monitored? Multi-site operations are audited by CABs that have been accredited for multi-site certification by ASI. That means that they have the resources, expertise and capacity to audit multi-site operations and have been authorized to make certification decisions based on their audits against the ASC requirements. Audits of multi-site operations include two distinct elements. First is an evaluation of the central office. This is conducted to: ensure that the client has full operational control of all sites included in the certificate, that procedures are in place to ensure full conformity with the ASC requirements, that the procedures have been implemented by trained and qualified personnel, and that the central office conducts monitoring and oversight of all sites to ensure that each is in full conformity with ASC requirements. Second is an evaluation of the sites. The initial audit will include onsite evaluations of all sites. For surveillance and re-certification audits, the number of sites to be evaluated is based on a risk assessment of the operation. Sites for audit are selected based on identified risks. In most cases, some of the sites are selected randomly to ensure that all elements of the operation are covered in the audit. The site evaluations are conducted to: ensure the operation at each site conforms with ASC Standard requirements, and ensure that the operational procedures of the central office are fully implemented. It is important to note that the requirements for multi-site certification included in this package for consultation supplement the requirements in ASC Standards and the CAR. Nothing in this proposal removes or replaces requirements that currently apply to individual certificate holders. ASC is also planning the development of a document ASC Certification Requirements which will include all requirements an applicant for certification or a certificate holder must know and comply with. Currently this information is in the ASC CAR. The ASC Certification Requirements will be a normative document for the CABs, just as the applicable species standard. FAQ The following questions have arisen in the consultations on this proposal: 1. This sounds really complex will ASC and the CABs be able to implement it? First, most professional conformity assessment bodies (CABs) have staff that are already trained and experienced in evaluating management systems and in conducting risk assessments, so yes, they can do it. March 2017 Page 2 of 5

3 Secondly, this system is designed for a certain type of client not all operators of multiple sites will benefit from this approach, unless they meet the specified requirements in the proposed methodology. CABs should be able to guide applicants to the best option for their operation. Thirdly, yes it is complex. Operations that can manage complexity are the prime candidates for this option. Operations that manage multiple sites have a tough job and those that are successful have in place the systems, staff and capacity to make sure that each site is managed to the level mandated. This proposal has been designed to draw on the best elements of management system requirements measured against the performance delivered at the operational sites. Fourthly, multi-site certification is more difficult to achieve than single site certification because of the need to have a robust central office and to consistently deliver performance that meets ASC Standards at all the certified sites. 2. Why a maximum of 50 sites? This number is a place to start with. If an applicant has more than 50 sites, meets all the other multi-site certification requirements and wants them all in a single certificate, the CAB can submit a variance request to ASC. ASC may choose to adjust this number in the future based on experience. 3. Why are multi-site applicants not evaluated using the same rules as groups? Put briefly, because multi-site operators are not groups. Groups are made up of separately owned or managed sites that have joined for the benefits of working with others. Because of this difference it is necessary to have different rules for group and multi-site certifications. 4. Will a focus on the management system of the central office take away from making sure that the ASC Standards are met? No. If it does ASC will change the rules so that it does not. Strong management systems that are supported by trained and qualified staff can deliver consistent performance at a site level and that is the reason that both are included in this proposal. The CABs will audit the management system of the multi-site operations but will also audit sites against the species standard. 5. Why use risk as part of this system? Auditors that are aware of the risk factors that may affect performance can ensure that particular attention is paid to those areas that may reduce the effectiveness of the management system or the performance level at individual sites. When auditors know the risks that may compromise performance they can pay special attention to those areas. March 2017 Page 3 of 5

4 6. What s with the sampling rate? Is it too high or too low? First, all audits use sampling. This includes single site audits as well. Normally samples are taken from a larger set for example an auditor faced with 1,500 invoices to check will normally select a sample of 39 invoices ( 1,500 = 39.) and check those. In this proposal, during the initial audit all sites must be audited and a square root of employees must be interviewed. As for surveillance and re-certification audits, formulas are set for low, medium and high risks that determine the size of the sample selected from the population. Medium risk is the default since it is the same sampling rate used in all single site audits. How the sample is selected is also important, an auditor may choose specific elements to audit based on risk and randomly select other elements. Auditors may also select some of the sample based on findings of previous audits. Note: the sample applies to the checking of performance against a particular requirement the auditor is required to check performance of all the ASC requirements. (So, no, an auditor is not free to just pick some of the ASC requirements to check, they must check all requirements at the picked sample sites.) 7. What happens when a non-conformity is raised? Multi-site certificates are issued to the client and cover all their operations. This means that individual sites are not certified separately. If a non-conformity is raised, it is the responsibility of the certificate holder to resolve it following the steps laid out in section of the CAR. This includes conducting a root cause analysis and developing an action plan that includes corrective and preventive actions. Corrective actions are those that correct the non-conformity and preventive actions are those that ensure that the nonconformity does not reoccur. In multi-site operations, steps may be taken that address a non-conformity that is contained to a single site. The CAB may require that product from a site to be segregated and not enter the certified chain of custody or quarantined to prevent the spread of an infection or other contaminant. These actions are normally designed to ensure that a product that does not conform to ASC requirements does not get sold as certified. The CAB may lift these restrictions once they are satisfied that the risks are mitigated. In addition, the certificate holder may request that the CAB remove the site from the scope of the certificate. This action would likely be taken if the CAB finds that addressing the non-conformity is not possible by the certificate holder. This could result from external factors such as infections or contamination from sources outside the control of the certificate holder. New sites can only be added by the CAB after he/she has conducted an audit of each new site. Sites that are removed from a certificate can only be added back into a certificate at the next full re-certification audit and after each site has been audited. March 2017 Page 4 of 5

5 It must be clear that one or several well performing site(s) cannot be used to excuse one or more poor performing sites. A major non-conformity at one site does not become a minor nonconformity because there are sites where it does not occur. A major non-conformity remains such no matter where it is found. At the same time a minor non-conformity that occurs at each site sampled may also be evidence of a major non-conformity of the central office s responsibility to ensure that obligations at the site level are being met, either through a failure of the management system, its implementation or the training of the staff that do the work. March 2017 Page 5 of 5